Category Archives: Biomedical Engineering

Biochemicals, Biomedical Engineering, Biopharmaceutical, Biotech, Biotechnology, Healthcare, Microarrays, Pharmaceuticals, Science

MicroTissues, Inc. Announces New Product Launch for the 3D Petri Dishâ„¢

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MicroTissues, Inc. announced today the launch of its 3D Petri Dishâ„¢ line of products. The 3D Petri Dishâ„¢ is a new tool for the world wide industry of life sciences research and drug discovery. Invented at Brown University, the 3D Petri Dishâ„¢ grows living human cells in three dimensions (3D) where they replicate the function of natural tissues and organs. There are important applications for these human 3D microtissues in cancer and stem cell research as well as toxicity testing, drug discovery and cell therapy.

“The scientific community has recognized the need for a reliable 3D cell culture technology that accurately produces natural cell-to-cell interactions and is easy to use” said Brian Morgan, Marketing Manager of MicroTissues, Inc. “Not only does our 3D Petri Dish™ line of products create 3D microtissues without artificial scaffolds, the microtissues are uniform in size, easy to harvest and accessible to the standard biochemical and microscopy methods that cutting edge labs demand. No other 3D cell product has all these technical advantages. And, we have the only reusable product.”

MicroTissues, Inc offers eight products that are precision micro-molds used to cast 3D Petri Dishesâ„¢ that fit in standard multi-well plates. The micro-molds are autoclavable and reusable. In a single pippetting step, the 3D Petri Dishâ„¢ forms hundreds of spheroids (hepatospheres, cardiospheres, mammospheres, neurospheres, and embryoid bodies), and microtissues with more complex shapes and geometries. Over thirty different cell types, including primary human cells, have been shown to form 3D microtissues in the 3D Petri Dishâ„¢.

MicroTissues, Inc. a privately held company with an exclusive worldwide license to US and international patent applications on the 3D Petri Dish™, is advancing technologies and applications of 3D cell culture.

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MicroTissues, Inc.’s 3D Petri Dishâ„¢ Is Helping to Reduce Animal Use in Research

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MicroTissues, Inc. announced today that its 3D Petri Dish™ is targeted towards helping to reduce the numbers of animals used in research. The 3D Petri Dish™ is a new tool for the world wide industry of life sciences research and drug discovery that grows living cells in three dimensions (3D). These 3D microtissues replicate the function of natural tissues and organs better than conventional 2D methods and are increasingly being used in toxicity testing of new drugs and cosmetics.

“Worldwide, efforts are underway to reduce the use of animals in research and we’re excited to be offering a new technology for toxicity testing” said Brian Morgan, Marketing Manager of MicroTissues, Inc. “The 3D Petri Dish™ is a reliable 3D cell culture technology that accurately produces natural cell-to-cell interactions and is easy to use. And, it forms 3D microtissues from human cells, so toxicity testing data is more relevant.”

Effective 2009, the European Union banned the use of animal testing for cosmetic products and many believe the trend to reduce the use of animals in research will continue worldwide. MicroTissues, Inc. is helping to address this issue by offering eight products that are precision micro-molds used to cast 3D Petri Dishesâ„¢ that fit in standard multi-well plates. The 3D Petri Dishâ„¢ forms hundreds of multi-cellular 3D spheroids from cells useful for toxicity testing including hepatospheres, cardiospheres, mammospheres, neurospheres, and embryoid bodies. The 3D Petri Dishâ„¢ technology also forms microtissues with complex shapes having geometries that mimic natural organs. Over thirty different cell types, including primary human cells, have been shown to form 3D microtissues in the 3D Petri Dishâ„¢.

MicroTissues, Inc. a privately held company with an exclusive worldwide license to US and international patent applications on the 3D Petri Dish™, is advancing technologies and applications of 3D cell culture. The company’s products stand above the rest because they are designed to create more natural and more reliable 3D cell culture environments based on cell-to-cell interactions in convenient and consistent formats that generate high content information. The company’s lead line of products, the 3D Petri Dish™, is serving the needs of researchers in a wide range of areas including cancer research, stem cell biology, toxicity testing, developmental biology, drug discovery, regenerative medicine and tissue engineering. In addition to products for basic research, MicroTissues, Inc. is using its platform technology to pursue applications in drug discovery and cell therapy. For more information, please visit www.microtissues.com.

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MicroTissues, Inc.’s 3D Petri Dishâ„¢ Used in Time Magazine’s Medical Breakthrough of 2010

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MicroTissues, Inc. announced today that its 3D Petri Dish™ was used in one of Time magazine’s medical breakthroughs of 2010. Researchers at Brown University and Women and Infants Hospital used the 3D Petri Dish™ to invent the first artificial human ovary, a discovery important for fertility research and a possible infertility treatment for cancer patients. In lab studies, the investigators used the 3D Petri Dish™ to assemble three different cell types into a 3D structure resembling an ovary where they functioned for all intents and purposes like a real ovary, even successfully maturing a human egg from its earliest stages in the follicle to a fully developed form.

“This is an exciting medical breakthrough and an significant validation of the importance of the 3D Petri Dish™ technology” said Brian Morgan, Marketing Manager of MicroTissues, Inc. “Cell-to-cell interactions are critical for the function of the ovary and the 3D Petri Dish™ is designed to promote these interactions. The honeycomb shaped 3D microtissue used in these studies is a great example of the kinds of complex shaped microtissues that can only be produced with the 3D Petri Dish™.”

MicroTissues, Inc offers eight products that are precision micro-molds used to cast 3D Petri Dishes™ that fit in standard multi-well plates. The micro-molds are autoclavable and reusable. The 3D Petri Dish™ is used to form 3D spheroids and microtissues with more complex shapes and geometries such as toroids and honeycombs. Over thirty different cell types, including primary human cells, have been shown to form 3D microtissues in the 3D Petri Dish™.

MicroTissues, Inc. a privately held company with an exclusive worldwide license to US and international patent applications on the 3D Petri Dish™, is advancing technologies and applications of 3D cell culture. The company’s products stand above the rest because they are designed to create more natural and more reliable 3D cell culture environments based on cell-to-cell interactions in convenient and consistent formats that generate high content information. The company’s lead line of products, the 3D Petri Dish™, is serving the needs of researchers in a wide range of areas including cancer research, stem cell biology, toxicity testing, developmental biology, drug discovery, regenerative medicine and tissue engineering. In addition to products for basic research, MicroTissues, Inc. is using its platform technology to pursue applications in drug discovery and cell therapy. For more information, please visit www.microtissues.com.

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Gene Therapy and Stem Cell Therapy Standard Developed For A Unique Derivative Of Post Hetero-Plastic Inplantation Chronic Inflammation Syndrome, The NIDO Disease

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Researchers task force, led by faculties of T-Protocol, registered Genom Project as controlled genom project in the hosted database of NCBI, a publication matter authority and function assigned organization under oversee of Department of Health & Human Services, reached once to share the exegetical impression officially pre-published concerning the understanding specific spectrum of symptoms covering boroad range of character usually complained and observed through chronic inflammation, granuloma, some types of lymphoma and various uncommon symptoms to let physician scientists suspecting indicium of neurological diseases, NIDO disease, an unique type of post hetero-plastic implantation chronic inflammation syndrome and setting Massachusetts indications of treatments standardized manual (Massachusetts manual) & diagnostic and standardized medical treatment manual for post hetero-plastic inplantation chronic inflammation syndrome, specific edition against NIDO Disease.

The once defined causes of NIDO disease, an unique type of post hetero-plastic implantation chronic inflammation syndrome are considered each of a common living organism to cause conformational diseases like Creutzfeldt-Jakob disease, Alzheimer’s disease, Parkinson’s disease, Huntington’s disease and kinds of and a set of biochemical and physical reaction and response realized by cross-species gene- mutation, as biotransformation, easily describing natural physiological and biochemical changes in vivo substrate of human bodies. After this studies, standardized protocol of gene therapy and applied stem cell therapy is now in practice and on available.

Faculties,committing themselves entirely to the project, of each institutes and organizations participating the project to ascertain proteins and DNA/genomic DNA/genom of human, other mammal and virulent microorganism including bacillus/virus affecting each symptom and the symptoms’ spectrum expressed generally and observed commonly on patients suffered from NIDO disease, extraordinarily unique derived type of post hetero-plastic implantation chronic inflammation syndrome and to develop diagnostic standard and treatment protocol standardized and to find a clue compose gene therapy protocol and applied stem cell therapy protocol to entirely heal NIDO disease, an unique type of post hetero-plastic implantation chronic inflammation syndrome and to let all of current suffered patients from various combined symptoms directly derived by chronic inflammation and various tumors, have to express full surprise at the fact that these disease and patients suffered are made up and left no attention and no relief.

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Nationaly Registered T-Protocol Of Genom Project Successfully Applied To Retrieve Bio Mechanism Of Hair Regrowth

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Division of Gene Medicine & Stem Cell Application, School of Medical Science, complete the research and established completely new protocol totally recovering natural bio mechanism of hair regrowth.

The researchers, led by Lord. Prof. Dr. Daichent Otto Rie, specified protein and genom to affect internal bio mechanism to generate hair and control the level of successful growth being low which is the baldness.

The key cast of the set of the bio cycle is hair follicles, which is stem cell on head skin and effect or holding function to cure many neurotic diseases and disorders like Alzheimer’s disease – Prion Disease and even Trion Disease (Post Hetero-Plastic Implantation Chronic Inflammation Syndrome; PhCIS) has absolutely unique character being retrieved absolute stem cell, which can recover the ability as stem cell after got adult. The key genom and DNA has been found through the Genom Project’s T-Protocol research developing in the government registered Genom Project since 2005. The most concentrated attention of researchers is not “what is cause” but “What protocol is best”.

The team of Prof.Daichent has successfully completed in vivo and in vivro experiment actually using voluntary patients whose types of hair loss being across over highly wide range extent to even lymphoma and cancer and finally established next genetic hair loss curing treatment protocol mainly composed of stem cell therapy and gene therapy.

Most of cases are treatable through entry level stem cell theraputic technique or HIV-1 Vector using high level technique but A20 introduction as gene therapy is required when treating patients being suffered from lymphoma, cancer or any neurotic diseases like Alzheimer’s disease – Prion Disease and even Trion Disease (Post Hetero-Plastic Implantation Chronic Inflammation Syndrome; PhCIS).

As Prof.Daichent points since 2005 being on School of Public Health of Harvard, in the treatment manual (published 2005), the key factor to overcome of lymphoma and chronic inflammation on human skin is extraordinary redundancy coding of polyglutamine DNA synthesis as the type of disease caused by pathological proteins and lack or heavy impairment of an specific DNA of A20.

Actually, the treatment protocol curing for baldness is also found through T-protocol which was essentially aimed at achieving causal and complete treatment of lymphoma, cancer, chronic inflammation and many neurotic diseases. Under control over the T-Protocol, all of clinical practitioner must always keep their eyes on the fact of using steroid is taboo over administration so being strictly prohibited. And also the technique must be under control of the competent faculty accredited by board in accordance with Europ.Gene Institute or specifically set physically area solely for research and clinical practice of nations like Switzerland, Germany, India, Hongkong, U.K. territories (NEVER inside U.K.) appointed by protocol developer and assigned practice entity.

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Turkey’s Biopharmaceutical Sector Attracts, Boosts Research and Development Expenditures

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A recent report on the biopharmaceutical sector presence, employment, economic output and research and development activity in the European States highlights Turkey’s long-term prospects for growth. The report notes that the industry is creating a positive ripple across the region’s economy, improving the quality of life for its citizens and increasing access to medicine.

In particular, strong public-private industry collaborations and an emphasis on research and development are highlighted as aiding in the development of new medicines, improving access to medicine and increasing the economic benefits of the region. Güler Hülya Yılmaz, head of Deloitte Turkey’s Health and Drug Industry division, emphasizes the importance of research and development (R&D) in the biopharmaceutical sector. Yilmaz states, “In R&D, it’s important that there be a strong foundation for laying the bricks of innovation. Turkey has that foundation, but with this there is a need for government support of new research and partnerships between industry and academia.”

Global Health Progress (GHP) also believes proper support for research and development in the pharmaceutical industry can contribute to the Turkish economy far beyond drug development and production. For example, the Turkish biopharmaceutical market has expanded rapidly, generating approximately US $8.5 billion in revenue in 2008 and contributed thousands of high-quality, highly skilled jobs to the region. Fortunately, recent reforms and policy changes by the Turkish government have created a more favorable environment for R&D investment. For example, the Turkish government has implemented a number of Technology Development Zones, which feature exemptions from income and corporate taxes on profits derived from R&D activity, an exemption from taxes on the wages of R&D personnel employed in the zones and value added tax (VAT) exemptions, all through 2013.

Additionally, the country’s sizeable pool of patients for clinical trials can bring health benefits, diffusion of medical knowledge and greater patient access to medicine and high quality care to citizens. With a population of approximately 72 million and a growing middle class, chronic diseases represent the majority of Turkey’s disease burden. An increased focus on prevention, early intervention, new treatments, and public-private partnerships, including recent government, university and industry collaboration facilitated by the establishment of several research institutes, is critical to reducing the health and economic burden of disease in Turkey.

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Catalent to Present Webinar on Regulatory Documents Surrounding Extractables and Leachables Testing Requirements

Catalent Pharma Solutions will host a free webinar featuring Principal Scientist, Alan D. Hendricker, Ph.D. The one-hour webinar provides an introduction to the regulatory documents surrounding leachables and extractables testing requirements for pharmaceutical products intended for US submission. The presentation, titled “Leachables and Extractables: Regulatory Context,” will be held on Thursday, March 18th from 2:00 p.m. to 3:00 p.m. EDT. To register for the webinar, please visit: https://www2.gotomeeting.com/register/290022131.

Catalent to Present Webinar on Regulatory Documents Surrounding Extractables and Leachables Testing Requirements

The presentation will be beneficial to all managers, directors, and vice presidents of small and large pharmaceutical companies that are working in product development of all dosage forms. The regulatory documents covered will include those for MDI, DPI, nasal spray, topical, oral and parenteral drug products. Additionally, the webinar will explore other applicable guidance and recommendation documents including: ICH guidance, Product Quality Research Institute (PQRI) recommendations, and EMEA and FDA guidance on genotoxic and carcinogenic impurities. The webinar will conclude with direction on modern approaches to applying this information in an analytical laboratory.

Catalent Pharma Solutions provides expert extractables and leachables services to the pharmaceutical industry with a focus on applying their industry leading scientific, regulatory and compliance expertise to all dosage forms and drug delivery platforms. Participants can expect to learn from Catalent’s expertise in these areas and take away an understanding of regulatory documents surrounding extractables and leachables testings, modern approaches and strategies to these testings, and guidance in analytical laboratory actions.

For more information on Catalent’s broad range of drug and biologic development services, go to www.catalent.com/development.

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Gregory T. Bleck, PhD. To Co-Chair Cell Line Development And Engineering Conference

Gregory T. Bleck, PhD., Senior Director of Cell Line Engineering for Catalent Pharma Solutions, will be co-chairing the Cell Line Development and Engineering conference being held in San Francisco, California on February 25-26, 2010.

Gregory T. Bleck, PhD. To Co-Chair Cell Line Development And Engineering Conference

In addition to co-chairing the conference, Dr. Bleck will be presenting “Characteristics of an Effective Mammalian Cell Line Generation Process for Bio-Pharmaceutical Production.” His session will explore how steps in the generation of mammalian cell lines have been optimized to make the process more efficient. Dr. Bleck will also outline certain approaches to improve timelines and throughput. Additionally, data collected f r o m Catalent’s development of more than 200 cell lines, each producing a different antibody or recombinant protein, will be reviewed.

Dr. Bleck received his BS and Ph.D. f r o m the University of Wisconsin-Madison, and performed postdoctoral work at the University of Illinois-Urbana working in the areas of gene regulation and expression, and joined Catalent Pharma Solutions in 1998. At Catalent, he transferred his knowledge of gene expression and transgenic systems to the development and continued optimization of retrovector expression systems and is one of the developers of the GPEx® gene expression technology. Dr. Bleck has published over fifty-five research papers and authored three book chapters. He has seven issued patents and eight patents currently under review.

For more information on Catalent’s broad range of biopharmaceutical development services, go to http://www.catalent.com/development.

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Maastricht University And PharmaCell Publish Results On Possible Improved Immune

In a collaborative publication in the prestigious journal Blood that appears this week, PharmaCell BV, the Maastricht University, Institute for Research in Biomedicine in Switzerland and the Research Center for Allergy and Immunology in Japan present data on a novel approach to improve treatment of acute leukemia patients. In a study that received a grant from the Dutch governmental organization SenterNovem, the consortium has shown that hematopoetic stem cells, commonly used in the treatment of those patients, can be cultured such that they show clear signs of an improved capacity to repair the immune system.

Maastricht University And PharmaCell Publish Results On Possible Improved Immune

Patients suffering from acute myeloid leukemia can be cured by hematopoetic stem cell transplantation, but many viral or bacterial infections occur after the treatment and are life threathening. The protocol developed by the consortium can potentially reduce the period after treatment that the patient is susceptible to such opportunistic infections.

The proposed treatment may greatly reduce morbidity and mortality in those patients. In the study that was conducted in mice, it was found that the stem cells treated with their protocol quickly migrated specifically to the thymus and matured there into effector cells of the immune system. Further research is needed to delineate the precise mechanism of action and to prepare the technique for application in patients.

Alexander Vos, CEO of PharmaCell comments: “The outcome of this projects shows the strength of consortia in which academia collaborates with industry. It has enabled us to keep a focus towards clinical application in a research project that had fundamental questions. As a company that focuses on the development and production of cell therapies, this research fitted very well in our profile. We are very pleased with the collaboration as well as with the outcome. PharmaCell intends to closely follow future developments in this project and will expertly support future clinical application of this cell therapeutic application where possible.”

Dr. Gerard Bos, who together with Dr. Wilfred Germeraad,is the lead investigator of the Division of Heamatology, Department of Internal Medicine of the Maastricht University Medical Center+ announces: “We believe that the potential of this technique to improve patient care is high. Further research is needed before application in patients is possible, but we feel very confident about that. The research has been carried out by a very strong international group of scientist and the results are convincing. We are looking forward to further developing the method.”

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Catalent Solidifies Inhalation Product Development Capabilities With New Offering

Catalent Pharma Solutions has acquired advanced fine powder filling capability, which solidifies Catalent’s position as a leader in development and manufacturing services to the pharmaceutical inhalation sector. With the purchase of Harro Höfliger’s Omnidose filling equipment, Catalent now offers its customers fully scaleable dry powder inhaler (DPI) filling capability. This widely-accepted technology, to be housed in Catalent’s Research Triangle Park, North Carolina facility, provides a flexible platform to reliably support all clinical manufacture through Phase II/III and a scaleable path to higher volume late stage clinical and commercial manufacturing.

The Harro Höfliger equipment is an advanced technology specialized in powder filling for microdosing, in the 1 – 300 mg of powder range, into an array of DPI formats to include both capsule-based and pre-metered blister device formats. This new capability gives Catalent a full range of pulmonary and nasal services, filling a gap in the marketplace for advanced powder filling capabilities. Catalent will now be able to serve as a one-stop-shop for the development of all inhalation dosage forms, possessing both the capital assets and technical experience. This recent addition complements Catalent’s pre-existing automated pMDI infrastructure.

Catalent’s primary location for inhalation product development is in Research Triangle Park, North Carolina where its experienced team offers comprehensive pulmonary and nasal services to help take a product from concept through regulatory approval. Catalent has extensive experience with all pulmonary dosage forms including pMDIs, DPIs, nasal sprays and solutions/suspensions for inhalation. For more information on Catalent’s proficiency in dosage form selection, technology assessment, formulation development, analytical testing and supplying toxicological and clinical trial materials, please visit www.catalent.com/development.

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Senior Director of Biotechnology at Catalent To Lead Immunogenicity Course

Ana T. Menendez, Ph.D., Senior Director of Biotechnology at Catalent Pharma Solutions, will lead a two-day international course on immunogenicity. The course will take place at the Regus Victoria in London on Wednesday, December 2 through Thursday, December 3, 2009.

The interactive course, titled “Introduction to Immunogenicity,” will enable attendees to better understand ways to detect, reduce and characterize unwanted immunogenicity. Additionally, Menendez will aid in interpreting the latest regulatory guidelines, and will assist attendees in formulating a winning strategy to implement in their business immediately.

The sessions will include a formal presentation by Menendez followed by facilitated breakout groups where delegates will be given the opportunity to apply the principles taught in the sections. Case studies, cut-point exercises and protocol workshops will increase the participants’ hands-on experience in developing and validating sensitive and rugged methods to detect and characterize unwanted immunogenicity.

As part of Catalent’s Development and Clinical Services Segment, Dr. Menendez is responsible for the release tests required to verify the functionality and purity of biotechnology products and the complex processes involved in their manufacture. Menendez implemented biotesting at Catalent and currently leads the following laboratories at the North Carolina Research Triangle Park facility: Cellular Technologies, Molecular Technologies, Virology and Analytical Biosafety. The expertise of the department ranges from proteins (i.e., monoclonal antibodies, enzymes, growth factors) to therapeutic viruses, bacterial vaccines and aptamers. Menenedez is an international instructor on bioassay development and validation and a frequent speaker at biopharmaceutical conferences.

For more information on Catalent’s broad range of drug and biologic development services, go to www.catalent.com/development.

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Senior Director of Biotechnology at Catalent To Present Course on Bioassays

Ana T. Menendez, Ph.D., Senior Director of Biotechnology at Catalent Pharma Solutions, will be leading a course in Bioassay Method Development and Validation. The course is being offered through IBC Life Science on November 12-13, 2009 in Boston, MA.

Menendez will present a lecture outlining sensible approaches to developing reproducible bioassays using live systems and/or biologically derived reagents. Additionally, Menendez will conduct a workshop on writing validation protocols, and will give participants hands-on experience and case studies, which will add relevance to lecture material as well as create a point of discussion. Targeted audiences are bio-analytical scientists, validation specialists, project management leaders and bioassay scientists involved in bioassay execution. Upon completion of the course, participants will receive a certificate of attendance.

Bioassays are necessary components of the biopharmaceutical development process as functional potency assays during release, stability and formulation studies. The course expands on the importance of the appropriate use of non-analytical techniques that are critical during PK/PD evaluation and measurement of systematic responses to drugs, such as immunogenicity. Also included are immunological and enzymatic methods that are widely used in the detection of biological impurities due to their increased sensitivity and specificity over analytical methods.

As part of Catalent’s Development and Clinical Services segment, Dr. Menendez is responsible for the release tests required to verify the functionality and purity of biotechnology products and the complex processes involved in their manufacture. Menendez implemented biotesting at Catalent and currently leads the following laboratories at the North Carolina Research Triangle Park facility: Cellular Technologies, Molecular Technologies, Virology and Analytical Biosafety. The expertise of the department ranges from proteins (i.e., monoclonal antibodies, enzymes, growth factors) to therapeutic viruses, bacterial vaccines and aptamers. Menendez is an international instructor on bioassay development and validation and a frequent speaker at biopharmaceutical conferences.

For more information on Catalent’s broad range of drug and biologic development services, go to www.catalent.com/development.

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Catalent Develops New Decorin Molecule Form, Strikes Deal With Euclid

Catalent Pharma Solutions, a leading provider of advanced technologies and outsourced development and clinical services to the global pharmaceutical and biotechnology industry, has announced the development of the Galacorin™ molecule, a proprietary form of the decorin molecule.

Catalent Develops New Decorin Molecule Form, Strikes Deal With Euclid

Catalent combined its proprietary GPEx® gene expression technology, Triplet-FixTM codon optimization technology and advanced scientific capabilities to greatly improve production and secretion of the GalacorinTM molecule in CHO cells. In addition, Catalent has developed a full cGMP production process for the GalacorinTM molecule.

Catalent has reached an agreement to provide the GalacorinTM molecule to Euclid Systems of Herndon, Virginia for an ophthalmic clinical trial. Financial terms of the agreement have not been disclosed. Additionally, Catalent is in the process of seeking partners for other indications.

Catalent’s proprietary GPEx® method of cell line engineering generates high-expressing, genetically stable cells for all mammalian cell types. Antibiotic selection is not needed as part of the procedure; multiple gene constructs can be added individually, at different gene ratios without any requirement for antibiotic resistance markers. The method allows re-production of cellular pathways within mammalian cell types as well as the ability to easily add protein processing enzymes to an already established cell line. Using conventional gene insertion and expression techniques, developing a stable biosimilar production cell line for a target protein can take as long as 18 months. Catalent’s GPEx® technology can overcome the inefficiencies of conventional systems and deliver a stable production cell line for target proteins in as little as 4.5 months.

For more information on Catalent’s broad range of drug and biologic development services, go to www.catalent.com/development.

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Senior Director of Biotechnology at Catalent To Lead Workshop on Immunogenicity for Biologics 2009

Ana T. Menendez, Ph.D., Senior Director of Biotechnology at Catalent Pharma Solutions, will be teaching a pre-conference workshop titled “Detection and Characterization of Immunogenicity of Therapeutic Biologics” on Monday, September 7, 2009 in Prague, Czech Republic. The course will focus on the practical technologies used to measure antibody responses to biologic drugs. The pre-conference begins at 10:00 a.m. The Immunogenicity for Biologics 2009 conference will be held on September 8-9, and will include additional discussion on outstanding technical issues, such as standardization and validation of assays as well as the interpretation and application of regulatory guidelines.

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As part of Catalent’s Respiratory, Analytical and Biotechnology group, Dr. Menendez is responsible for the release tests required to verify the functionality and purity of biotechnology products and the complex processes involved in their manufacture. Menendez implemented biotesting at Catalent and currently leads the following laboratories at the North Carolina Research Triangle Park facility: Cellular Technologies, Molecular Technologies, Virology and Analytical Biosafety. The expertise of the department ranges from proteins (i.e., monoclonal antibodies, enzymes, growth factors) to therapeutic viruses, bacterial vaccines and aptamers. Menendez is an international instructor on Bioassay Development and Validation and a frequent speaker at biopharmaceutical conferences.

The Immunogenicity for Biologics 2009 conference will cover case studies on assay challenges, FDA and European submissions IgG4 and IgE, pre-clinical and clinical strategies and aggregation. Participants will benefit from practical advice on the design and validation of neutralizing assays.

About Catalent
Headquartered in Somerset, New Jersey, Catalent Pharma Solutions is a leading provider of advanced dose form and packaging technologies, and development, manufacturing and packaging services for pharmaceutical, biotechnology and consumer healthcare companies in nearly 100 countries. Catalent applies its local market expertise and technical creativity to advance treatments, change markets and enhance patient outcomes. Catalent employs approximately 9,500 at more than 30 facilities worldwide and in fiscal 2008 generated more than $1.8 billion in annual revenue. For more information, visit http://www.catalent.com.

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Michael Jenkins, Phd, Of Catalent To Present Their GPEx® Technology At The 2009 BIO Process Theatre Taking Place At This Year’s BIO International Convention

Dr. Jenkins’ talk will focus on Catalent’s proprietary GPEx technology for mammalian cell culture engineering. The 2009 BIO International Convention takes place in Atlanta, GA, May 18-21.

GPEx® Technology

Dr. Jenkins’ presentation is titled “Bench to the Clinic: Using GPEx® Mammalian Cell Culture Engineering to Shorten Timelines, Reduce Risk, and Prepare for Success.” Presentation abstract: The speed at which a recombinant protein product progresses through candidate selection, process development, toxicology production and cGMP manufacturing is of vital importance to both small and large biotechnology companies. Dr. Jenkins will present ways to balance risk, speed and cost as well as ways in which Catalent’s proprietary GPEx technology for mammalian cell line engineering facilitates this process.

Catalent’s Middleton, WI facility is part of the organization’s Respiratory, Analytical and Biotechnology group. The 43,000 sq. ft. site houses process development laboratories, R&D and QC laboratory space, and cGMP product dedicated manufacturing suites withstirred tank bioreactors. Middleton also performs the proprietary GPEx™ technology for the engineering of high expressing, stable mammalian cell lines suitable for cGMP production of biopharmaceuticals.

About Catalent
Headquartered in Somerset, New Jersey, Catalent Pharma Solutions is a leading provider of advanced dose form and packaging technologies, and development, manufacturing and packaging services for pharmaceutical, biotechnology and consumer healthcare companies in nearly 100 countries. Catalent applies its local market expertise and technical creativity to advance treatments, change markets and enhance patient outcomes. Catalent employs approximately 9,100 at more than 30 facilities worldwide and in fiscal 2008 generated more than $1.8 billion of annual revenue. For more information, visit www.catalent.com.

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Two Catalent Scientists, Dr. Tom Feinberg, Director Of Structural Chemistry Services, And Dr. Craig Davies-Cutting, Director Of Research And Development, Will Host A 45-Minute Interactive Workshop At RDD Europe 2009

Two Catalent scientists, Dr. Tom Feinberg, director of structural chemistry services, and Dr. Craig Davies-Cutting, director of research and development, will host a 45-minute interactive workshop at RDD Europe 2009. The conference is designed for academic, industrial and regulatory scientists involved in the development, investigation, preparation and delivery of existing and new therapeutic entities by inhalation. It takes place in Lisbon, Portugal, May 19-22, 2009.

The Catalent sponsored workshop is titled “Formulation and Leachables Considerations in Component Selection for Inhalation Drug Products.” Workshop abstract: Although the range of inhalation delivery devices and components has increased, the rate of new product approvals has not. One explanation is the need to thoroughly explore hardware and formulation compatibility and performance during product development. Additionally, global regulatory expectations have been raised since the publication and dissemination of the Product Quality Research Institute’s Safety Thresholds and Best Practices for Extractables and Leachables in Orally Inhaled and Nasal Drug Products. This workshop outlines an optimized approach for formulation-device combination screening and selection, and discusses the impact of leachables and materials characterization methods selection on the testing timeline.

Dr. Feinberg and Dr. Davies-Cutting are members of Catalent’s Respiratory, Analytical and Biotechnology group, based in North Carolina’s Research Triangle Park.

About Catalent
Headquartered in Somerset, New Jersey, Catalent Pharma Solutions is a leading provider of advanced dose form and packaging technologies, and development, manufacturing and packaging services for pharmaceutical, biotechnology and consumer healthcare companies in nearly 100 countries. Catalent applies its local market expertise and technical creativity to advance treatments, change markets and enhance patient outcomes. Catalent employs approximately 9,100 at more than 30 facilities worldwide and in fiscal 2008 generated more than $1.8 billion of annual revenue. For more information, visit www.catalent.com.

Via EPR Network
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Catalent Scientist’s Article Featured by Biotechnology Industry Organization

An article written by Ana T. Menendez, Ph.D., Senior Director of Biotechnology at Catalent Pharma Solutions, was featured in the Biotechnology Industry Organization’s (BIO) March 2009 e-Newsletter. The article, titled “A Guide to Accelerating Bioassay Transfer in the GMP Environment,” highlights important questions and steps to set timelines and prepare for a successful bioassay transfer. Dr. Menendez’s work, along with a number of articles written by industry leaders, is being offered for free download on BIO’s website - www.bio.org.

According to Dr. Menendez, “Setting realistic timetables, creating thorough documentation to transfer bioassays between organizations, and working with a highly qualified CRO are the keys to streamlining the production of biologics and accelerating their time to market.” Her article goes on to provide guidelines to help increase clarity in setting timelines, along with illustrative case studies where delays could have been avoided.

As part of Catalent’s Respiratory, Analytical and Biotechnology group, Dr. Menendez is responsible for the release tests required to verify the functionality and purity of biotechnology products and the complex processes involved in their manufacture. Dr. Menendez implemented biotesting at Catalent and currently leads the following laboratories at the North Carolina Research Triangle Park facility: Cellular Technologies, Molecular Technologies, Virology and Analytical Biosafety. The expertise of the department ranges from proteins (i.e., monoclonal antibodies, enzymes, growth factors) to therapeutic viruses, bacterial vaccines and aptamers. Dr. Menenedez is an international instructor on Bioassay Development and Validation and a frequent speaker at biopharmaceutical conferences.

About Catalent
Headquartered in Somerset, New Jersey, Catalent Pharma Solutions is a leading provider of advanced dose form and packaging technologies, and development, manufacturing and packaging services for pharmaceutical, biotechnology and consumer healthcare companies in nearly 100 countries. Catalent applies its local market expertise and technical creativity to advance treatments, change markets and enhance patient outcomes. Catalent employs approximately 9,100 at more than 30 facilities worldwide and in fiscal 2008 generated more than $1.8 billion of annual revenue. For more information, visit www.catalent.com.

Via EPR Network
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Consistent Development Of Stable-High Expressing Mammalian Cell Lines In Four Months Using Gpex®

Dr. Greg Bleck, the senior director of cell line engineering at Catalent Pharma Solutions, will present later this month at the 12th Annual Pep Talk 2009 Protein Expression Conference to be held in San Diego, C.A., January 12-14, 2009. The conference offers a strong scientific program with more than 120 presentations and poster sessions reviewing the latest research and leading edge technologies in the field.

Dr. Bleck’s presentation is titled “Consistent Development of Stable-High Expressing Mammalian Cell Lines in Four Months Using GPEx®.” Catalent’s proprietary GPEx® method of cell line engineering generates high-expressing, genetically stable cells for all mammalian cell types. Antibiotic selection is not needed as part of the procedure; so multiple gene constructs can be added individually, at different gene ratios without any requirement for antibiotic resistance markers. This allows re-production of cellular pathways within these cell types as well as the ability to easily add protein processing enzymes to an already established cell line. Specific productivities of GPEx® antibody producing cell lines range from 30 -70 picograms/cell/day without upstream process development, while cell lines producing non-antibody proteins as expected have a much broader range of productivities, but if the protein has no secretion problems and does not inhibit cell growth, specific productivities similar to antibodies are obtained.

About Catalent
Headquartered in Somerset, New Jersey, Catalent is one of the leading providers of advanced dose form and packaging technologies, and development, manufacturing and packaging services for pharmaceutical, biotechnology and consumer health companies in nearly 100 countries. Catalent applies its local market expertise and technical creativity to advance treatments, change markets and enhance patient outcomes. Catalent employs approximately 9,500 at more than 30 facilities worldwide and generates more than $1.8 billion of annual revenue. For more information, visit www.catalent.com.

Via EPR Network
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Dr. Greg Bleck Of Catalent Pharma Solutions, Will Present At The 2nd International Cell Engineering Conference

Dr. Greg Bleck, the senior director of cell line engineering at Catalent Pharma Solutions, will present this week at the 2nd International Cell Engineering Conference to be held in Santa Barbara, C.A., December 2-4, 2008. The conference will include presentations by leading pharmaceutical companies, small biotech organizations, academics, and key technology supply firms covering the latest advancements in cell line development. Special emphasis will be placed on the reliability and reproducibility of the more promising cell engineering techniques. The conference is produced by the Williamsburg BioProcessing Foundation.

Dr. Bleck’s presentation is titled “Generation of Stable-High Expressing Mammalian Cell Lines in Four Months without Antibiotic Selection or Gene Amplification Using GPEx®.” Catalent’s proprietary GPEx® technique for cell line engineering allows high-expressing, genetically stable cells for any mammalian cell type to be produced without antibiotic selection or gene amplification. The lack of selection and amplification allows these master cell bank candidate cell lines to be made in four months, and permits research and development scientists to contemplate new paths for improved expression of their proteins. The candidate cell lines range in specific productivities from 30-95 picograms/cell/day for antibodies and have reached as high as 50-70 picograms/cell/day for some recombinant protein producing cell lines. Cell lines producing over 150 different antibodies and 40 different recombinant proteins have been developed with GPEx®. Data showing the consistency and speed of the technology, as well as the stability and productivity of the cell lines will be presented.

About Catalent
Headquartered in Somerset, New Jersey, Catalent is one of the leading providers of advanced dose form and packaging technologies, and development, manufacturing and packaging services for pharmaceutical, biotechnology and consumer health companies in nearly 100 countries. Catalent applies its local market expertise and technical creativity to advance treatments, change markets and enhance patient outcomes. Catalent employs approximately 9,500 at more than 30 facilities worldwide and generates more than $1.8 billion of annual revenue. For more information, visit www.catalent.com.

Via EPR Network
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