Tag Archives: Medicine

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
More Biotech press releases

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
More Biotech press releases

Welcome to EPR Biotech News

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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