Category Archives: Biopharmaceutical

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Now, Women Can Bank On ‘Monthly Miracle’ For Future Treatment

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Women in the city will soon have the option of banking their menstrual blood so that menstrual blood stem cells can be used for treatment of serious disorders through stem cell therapy.

In six months, Life Cell International, in technology partnership with Cryo-Cell International, will set up the facility, which will be the first to store menstrual blood in the country.

Cryo-Cell, which has patented technology to decontaminate samples, started menstrual blood banks in the US last year, and other countries are yet to catch up. Cryo-Cell calls it ‘your monthly miracle’. The endometrium-lining of the uterus regenerates every month, suggesting the presence of stem cells. However, there is no published scientific work on the curative properties of such cells.

Stem cells have the ability to regenerate themselves through cell division and act as a repair system for the body. Research on stem cells provides knowledge about how healthy cells replace damaged ones in adults, leading to the possibility of cell-based therapy to treat diseases.

“Menstrual blood contains millions of stem cells that have many properties and characteristics similar to those of stem cells found in bone marrow and embryos. These stem cells exhibit capabilities for self-renewal and multi-potency,” says LifeCell International executive director Mayur Abhaya. Stem cell research hopes to find answers to problems such as cardiac and degenerative diseases, besides cancer.

The women would be given a collection kit comprising a menstrual cup and collection tubes. The blood would be processed and preserved in liquid nitrogen at extremely low temperatures.

Though the Chennai bank has not decided on the rates, it hopes registration will cost less than that charged for preserving cord blood. At present, the bank, which has stored over 13,000 samples of cord blood at a facility near Chennai, charges Rs 41,100 for collection, processing and storage of the blood for the first year. From the second, the client pays an annual fee of Rs 3,500 to preserve the blood for two decades.

The biggest advantage of menstrual blood, according to LifeCell chief scientific officer Dr Ajit Kumar, is that it can be easily harvested in a painless, non-invasive manner. “And it also extends the scope of stem cell therapy to a larger section of the people. Cord blood is an option open to only those who are pregnant or those planning babies,” he says.

At a time when legal restrictions on collection of embryonic stem cells have been stymieing research, the option to save menstrual blood is a boon because these cells have similar properties to that of cord blood, he adds.

Via EPR Network
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New Transplant Therapy, Shift in Drug Discovery

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On August 23-25, 2010, industry scientists, CEOs, and academics will convene at Philadelphia’s Four Seasons Hotel for the “Ubiquitin Drug Discovery and Diagnostics Conference” to discuss the Next Big Thing in drug discovery research—the ubiquitin pathway. Advances in oncology, infectious diseases, neurodegeneration, inflammation, diabetes, and muscle wasting will be covered.

New Transplant Therapy, Shift in Drug Discovery

A pathway is a sequence of reactions converting one molecule into another. Ubiquitin, which is a small protein, is used often to mark larger proteins within a cell for breakdown. This pathway plays fundamental roles in human health and disease; many human pathologies have been linked to changes in ubiquitin pathway enzymes. Attracting experts in this growing field, the three-day conference is unique in its focus on drug discovery within the ubiquitin pathway.

Rejection hurts; but for the recipient of organ donation, rejection can be fatal. New combination therapies for treating antibody-mediated rejection (AMR) in transplant patients are possible, thanks in part to manipulation of the ubiquitin pathway.

When a transplant recipient’s body rejects donor tissue, the recipient’s plasma cells, which typically fight off infection, are in fact the aggressors in the attack. Dr. Woodle suggests stalling the proteasome (or “cellular waste-bin”) via the ubiquitin pathway (or “cellular tagging and shipping information hub”) thereby depleting plasma cells and treating rejection. Dr. Woodle will present his latest findings during the final conference session.

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Website Recognizes Benefits of Biotech Crops

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A new website by The United Soybean Board (USB) highlights the important role biotechnology plays in allowing U.S. farmers to continue to meet the world’s food demand as well as ensuring our environment and food supply remains as safe as ever. Whether you know it as biotech, genetically modified or GM—the technology that allows farmers to grow more per acre with fewer inputs plays a critical role in feeding our growing world.

Website Recognizes Benefits of Biotech Crops

Biotechnology allows researchers to select the desired characteristics in a variety of seeds and crops, resulting in improved nutrition, increased pest and disease resistance and greater crop yields. This technology enables farmers to generate a sustainable supply of food, feed and fuel for customers here at home and abroad.

Click here for additional information on biotechnology.

About the United Soybean Board
The United Soybean Board (USB) represents a group of volunteer farmer-leaders administering a U.S. soy research and promotion program known most commonly as the “soybean checkoff.” Through the soybean checkoff, U.S. soybean farmers invest a portion of their sales in research and promotion to provide food, feed, fuel and fiber to the world. By building demand for such things as soy biodiesel, soybean meal, soybean oil, soy exports and more, USB and the soybean checkoff help provide profit opportunities for all U.S. soybean farmers.

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Stem Cells From Menstrual Blood May Benefit Stroke Patients

Cryo-Cell International, Inc. today announced results of a study published [this month] in the cover article of Stem Cells and Developmentshowing that stem cells found in menstrual blood may one day be a potential source for stem cell therapies in stroke and other central nervous system disorders. Menstrual stem cells, known as MenSCs, offer an easily accessible, non-controversial and renewable stem cell source with the potential to one day treat a host of diseases, such as stroke, osteoporosis, Alzheimer’s and Parkinson’s disease, according to a number of early studies. The study, entitled “Menstrual Blood Cells Display Stem Cell-Like Phenotypic Markers and Exert Neuroprotection Following Transplantation in Experimental Stroke,” was conducted by researchers at Cryo-Cell International, the University of South Florida , Saneron-CCEL Therapeutics and the Medical College of Georgia.

Stem Cells From Menstrual Blood May Benefit Stroke Patients

Because the cell damage after an initial stroke episode occurs over an extended time, treatment strategies directed at quickly rescuing these nerve cells have the potential to slow the disease progression and possibly restore nerve function. In this study, researchers found that transplantation of MenSCs, either directly into the brain or peripherally, significantly reduced behavioral and histological abnormalities, suggesting that the MenSCs had a protective effect on brain cells, averting further apoptosis, or cell death, and potentially reversing the neural trauma experienced during a stoke.

“The data shows immediate behavioral recovery at an early period after transplantation although the exact mechanism underlying the neural benefits of MenSCs remains unknown,” said lead researcher Cesar V Borlongan Ph.D., Professor and Vice-Chair of Neurosurgery and Brain Repair at the University of South Florida Health . “ We do know that several trophic factors have been identified post transplant that may potentially point to a secretion of therapeutic substances from MenScs versus one of cell replacement. Equally important, is that there was no instance of complications or negative effects such as detectable tumor, ectopic formation or overt graft-versus-host in any of the transplanted animals.”

During the study, the investigators analyzed shed menstrual blood and tissue to identify MenSCs. The samples were obtained using a menstrual cup and transferred to a laboratory for processing and cryopreservation. After inducing a simulated stroke (oxygen glucose deprivation, OGD) on adult rats, the researchers injected the rats withmenstrual blood –derived stem cells and found that those who were exposed to MenSCs exhibited a significantly reduced death rate. Behavioral assessments of motor coordination and neurological function were performed on the rats 14 days after stroke-transplantation and indicated improvements in both motor and neurological abnormalities.

“Compared to other stem cell sources, such as bone marrow and umbilical cord blood , MenSCs are harvested from a readily available and renewable source of adult mesenchymal stem cells. These novel and highly prolific stem cells are easily obtained using non-invasive methodology and create the potential for matched cell transplantations in large scale clinical trials,” said Julie Allickson, Ph.D., study investigator and Vice President, Laboratory Operations, Research and Development at Cryo-Cell International, Inc.

The benefits of stem cells derived from menstrual blood were first indicated in a study sponsored by Cryo-Cell that was published in Cell Transplantation in April 2008. That study demonstrated that MenSCs are stromal stem cells, meaning they have the capability to differentiate into important cells, such as such as bone, cartilage, fat, nerve and cardiogenic cells.

“Stroke is the third leading cause of death and disability in U.S. adults,” said Mercedes A. Walton, Cryo-Cell’s Chairman and CEO . “According to the American Heart Association, stroke will cost almost $68.9 billion in both direct and indirect healthcare costs in 2009. In view of these statistics, we are clearly encouraged by research study results that demonstrate significant promise for the development of regenerative medicine therapies to potentially treat and manage the debilitating conditions caused by stroke and possibly other neurological disorders.”

The Celle SM service is based on Cryo-Cell’s expansive IP technology portfolio and was introduced in November, 2007 as the first and only service that empowers women to collect and cryopreserve menstrual flow containing undifferentiated adult stem cells for future utilization by the donor or possibly first-degree relatives in a manner similar toumbilical cord blood stem cells. Based on the continued success of MenSCs in the research setting, Cryo-Cell is actively expanding its portfolio of research collaborations with world renowned scientists committed to study this novel stem cell population for a broad range of regenerative therapeutic development.

Via EPR Network
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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.

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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.

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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.

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LC Sciences announced the availability of probe content miRBase 10.0 for their microRNA (miRNA) microarray customers

Taking advantage of its flexible µParaflo™ Chip Technology, Houston based LC Sciences today announced immediate availability of probe content miRBase 10.0 for their microRNA (miRNA) microarray customers. This announcement comes less than a week after Sanger Institute’s update of their sequence database for known miRNAs (miRBase) 1 to version 10.0 (http://microrna.sanger.ac.uk/sequences). As the jump in

version numbers from 9.2 to 10.0 suggests, this update marks a major milestone and features significant changes: 489 new hairpin sequences and 971 novel mature miR and miR* experimentally verified products have been added.

These numbers represent an increase of unique miRNA sequences by 42%. “This exciting increase in data means that researchers using pre-spotted glass arrays with probe content based on versions as recent as 9.1 are missing 49% of mouse, and more than 50% of human sequences, just to give two examples. The other important point is that these sequences are experimentally verified and publicly available data. Unlike with proprietary probe content the researcher has full access and control over the results.” said Chris Hebel, Director of Business Development at LC Sciences.

The importance of this update is emphasized by another aspect of the release: many human, mouse and rat mature miRNAs were renamed and the sequence boundaries changed to reflect the predominant forms identified in recent large-scale cloning studies. The public miRBase sequence database serves as the primary probe content for many commercially available miRNA profiling microarrays. Detection of miRNAs using a microarray offers the opportunity for genome-wide miRNA expression profiling by examining all known miRNA transcripts in a single experiment. However, the continued updating of the database can be problematic for researchers using pre-spotted glass slide arrays as the probe content of the arrays immediately goes out of date whenever a new miRBase version is released. Especially, in a rapidly evolving field as miRNA research it is important to scientists to have the most complete picture of miRNAs expressed in their experimental samples.

LC Sciences miRNA microarrays make use of a microfluidics on-chip synthesis platform, termed µParaFlo™, versus a traditional spotted array based on pre-synthesized oligonucleotides. This on-chip synthesis platform solves the issue of out of date microarrays because made-to-order microarrays can be produced, delivering the most up-to-date research tools to researchers.

In addition to providing much more uniform and reproducible features than a spotted array, on-chip synthesis permits the total customization of content on each individual microarray opening up additional applications such as the discovery of new miRNAs and other small non-coding RNAs.

About microRNA (miRNA)
miRNAs are small non-protein-coding RNA molecules that function as negative regulators of gene expression by base pairing with specific mRNAs. This either inhibits translation or promotes mRNA degradation. About miRBase – The miRBase sequence database is a comprehensive database of miRNA sequence data, annotation, and predicted gene targets and is the primary public repository for these data. Release 10.0 of the database contains 5071 entries representing hairpin precursor miRNAs, expressing 4922 maturemiRNA products, in primates, rodents, birds, fish, worms, flies, plants and viruses (miRBase release summary). miRBase also provides a gene-naming service for assigning official miRNA names to novel miRNAs before they are published. It is freely available to all at http://microrna.sanger.ac.uk/.

About LC Sciences
LC Sciences offers specialty microarray services for nucleic acid/protein profiling and functional analysis, biomarker-discovery, and novel drug screening. Our array service products are based on Atactic Technologies’ µParaflo™ platform technologies that encompass advanced digital chemical synthesis, pico-liter scale biochemical assays, and microfluidic reaction devices containing high density individual 3D chambers.

 

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EPR Biotech News is a new blog, part of EPR Network, that is going to be focused on and will be covering the biotech news and stories from press releases published on EPR Network.

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