Tag Archives: pharma

Combined Shigella and ETEC vaccine candidate enters Phase 1 clinical study with radically innovative approach

VIENNA, 24-Sep-2020 — /EPR BIOTECH NEWS/ — Eveliqure Biotechnologies GmbH, an Austrian biotechnology company, today announces the initiation of clinical testing for its ShigETEC vaccine candidate, with the dosing of the first subject in a Phase 1 safety and immunogenicity study in Europe. ShigETEC is an orally administered vaccine candidate targeting Shigella and Enterotoxigenic E. coli (ETEC), two of the major pathogens responsible for diarrhoeal diseases in travelers to endemic countries, as well as a major threat to children living in low- and middle- income countries.

Currently no effective vaccines against these two pathogens exist and previous attempts to develop vaccines against Shigella and ETEC have failed. Eveliqure has employed a radically innovative approach based on a live attenuated Shigella vaccine strain rationally designed to provide broad, serotype independent protection against both Shigella and ETEC, and is developing the vaccine for both travelers to endemic countries and for children living in resource-poor countries. Following this initial Phase 1 study run in Hungary, further clinical development of ShigETEC will include Phase 1 testing in non-endemic adults, immune characterization of vaccine responses, vaccine formulation studies and clinical testing of ShigETEC in the pediatric population in resource poor-countries. These activities are supported by the EU-funded SHIGETECVAX international consortium of world-leading vaccine organizations – the European Vaccine Initiative, Eveliqure Biotechnologies, University of Gothenburg, icddr,b and PATH.

“Entering clinical development with ShigETEC marks a major milestone for Eveliqure, culminating from our extensive preclinical work performed over the past five years” – commented Gábor Somogyi, MD, MBA, Chief Executive Officer of Eveliqure. “We believe that ShigETEC has the potential to reduce the burden of diarrhoeal diseases for travellers, while also saving hundreds of thousands of children in endemic areas of the world”.

“Initiating the Phase 1 study for ShigETEC in adult volunteers is a crucial step towards establishing safety and immunogenicity of our vaccine candidate, and will help us define a well-tolerated, and effective schedule of dosing for our planned Phase 2 human challenge studies”. – commented Frank Malinoski MD, PhD, Chief Medical Officer of Eveliqure.

Compared to single pathogen approaches, ShigETEC has the potential to have a major impact on diarrheal diseases, protecting both travelers to the developing world and children in endemic populations.

SOURCE: EuropaWire

Global leader in flexible containment solutions ILC Dover expands its Irish production footprint by opening a location in Blarney, County Cork, Ireland

FREDERICA, DE, USA, 01-Nov-2018 — /EPR BIOTECH NEWS/ — ILC Dover, a global leader in flexible containment solutions for the pharmaceutical and biopharmaceutical industry is expanding its Irish production footprint by opening a location in Blarney, County Cork, Ireland.

The building will be operational in the first quarter of 2019 and outfitted with 4,000 square feet of

ISO 7 clean room capacity and 6,500 square feet of Class 8, both dedicated to the company’s pharmaceutical and biopharmaceutical product lines. When at full production, the company expects to hire 60-70 new ILC Dover employees. The company’s original operation in County Cork will be relocated to the Blarney site as part of the expansion project.

ILC Dover President and CEO Fran DiNuzzo expressed enthusiasm about the new launch: “The expansion of our production capabilities in Ireland will allow us to better serve our global customer base and strengthen our position as the leading single-use powder handling solutions provider to the global pharmaceutical and biopharmaceutical marketplace.”

In addition to production space, the new facility will contain state-of-the-art offices, meeting rooms and a product demonstration area for client visits. Curtis Gingles, Vice President and General Manager of the company’s Pharmaceutical Division, added, “Clients of ILC Dover will be happy to see that we’re focused on providing additional capacity located in the region with expanded technical resources. The market for our products is experiencing incredible growth and this expansion will ensure we can keep up with the growing demand for the high-quality products used in manufacturing lifesaving therapies.”

SOURCE: EuropaWire

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.

Via EPR Network
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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.

Via EPR Network
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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.

Via EPR Network
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