WHITE PAPER The High Bar for Gene Therapy CMC How drug developers can step up to meet regulatory expectations for gene therapy chemistry...
Read moreGene Therapies
Viral Clearance Studies for Gene Therapies—Easier Said Than Done
While incidents of biotherapeutic viral contamination have occurred, due to well-established knowledge of the potential sources of contamination and procedures to prevent...
Gene and Cell Therapy Developers Are Getting Creative to Keep Programs on Track During the Pandemic
Jeanette Young, senior consultant for analytical services at BioTechLogic talks with Tonia Becker, Life Sciences Editor, Macon Raine As it became clear that the COVID-19...
Lessons from the Pandemic and Addressing Gene Therapy Process Development Challenges
It’s a fascinating time to be in the biotherapeutics industry. What will the remarkedly rapid COVID-19 vaccine development effort teach us about how to develop and scale...
Gene Therapy CMC & Manufacturing Approaches Are Maturing
The gene therapy sector is maturing and the industry is poised to be able to produce products in more consistent and scalable ways. Although the COVID-19 pandemic caused...
Process Validation for Expedited Approval Drugs
WHITE PAPER Process Validation and Regulatory Review in the Age of Expedited Approval Drugs This paper explores those dynamics and offers some revised approach suggestions....
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