Potency is a critical quality attribute of biological products, defined by the US FDA as the specific ability of the product to cause the required therapeutically clinical benefit. Potency assay will ...
Since biological therapeutics are derived from living organisms, their manufacture and validation presents difficulties not encountered during traditional small molecule drug development. Despite the ...
Learn how viral vector release testing for AAV and lentiviral vectors utilizes orthogonal assays for titer, capsid content, ...
Armatus Bio, a late-preclinical stage biotech innovator developing vectorized RNAi medicines in neuromuscular disorders, today announced a new publication in Molecular Therapy Advances summarizing the ...
A good bioassay, like a good marriage, joins two partners in a bond and is mutually beneficial. In the case of bioassays, optimal design and development and accurate statistical analysis comprise a ...
Development of process analytical tools for rapid monitoring of live virus vaccines in manufacturing
In the development of end-to-end large-scale live virus vaccine (LVV) manufacturing, process analytical technology (PAT) tools enable timely monitoring of critical process parameters (CPP) and ...
Quality by design is critical for cell and gene therapy manufacturing where process controls directly influence product ...
MarinBio publishes validated GMP/GLP cell-based potency assay for AAV-delivered anti-CD3-anti-CD19 diabody (GP101) in Journal of Immunological Methods. This publication is a milestone for the cell & ...
Lot release testing of diphtheria, tetanus and acellular pertussis vaccines traditionally relied on in vivo protection models involving challenge of laboratory animals with toxins. Meanwhile, many ...
Officials from the US Food and Drug Administration’s (FDA) Office of Therapeutic Products (OTP) within the Center for Biologics Evaluation and Research (CBER) urged developers of gene therapies to ...
Amid the coronavirus pandemic, the US Food and Drug Administration has issued guidance on potency assays for manufacturers of monoclonal antibodies and other therapeutic proteins to treat COVID-19.
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