Bioprocessing White Papers
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Response To FDA Black Box Warning
3/1/2024
The FDA has launched an investigation into the risk of T-cell malignancies following CAR-T cell immunotherapies. Review the key points of this announcement concerning the CGT research community.
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Understanding Potency In Gene Therapy Development
2/28/2024
Explore the importance of understanding potency in cell and gene therapy (CGT) development and the challenges in developing potency assays for CGT products.
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Optimizing AAV Purification for High Recovery
2/27/2024
How can you improve purification methods for your AAVs and enhance the efficacy and safety of your gene therapy treatments?
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Mycoplasma Contamination In Biopharmaceutical Manufacturing
2/9/2024
Learn how following strict laboratory practices and conducting routine testing for Mycoplasma contamination using nucleic acid-based assays can help ensure the production of safe and high-quality biopharmaceutical products.
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Impact Of Immunogenicity On Efficacy And Safety Of Biosimilars
2/9/2024
The presence of anti-drug antibodies (ADAs) can affect the effectiveness and safety of biologic drugs. Read why regulatory agencies emphasize the need for extensive immunogenicity evaluation in biosimilar development.
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Quantitation Of Monoclonal Antibodies In Serum
2/8/2024
Monoclonal antibodies (mAbs) are a rapidly growing group of targeted therapeutics. Gain insight into the importance of optimized bioanalytical assay platforms for mAb development.
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Metabolite And Nutrient Analysis As Crucial Components For Optimal Upstream Process
2/8/2024
Discover how insights into cell metabolism can further enable the development of efficient cell culture processes through tailored nutrient supplementation and monitoring.
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Development And Regulation Of Veterinary Monoclonals
2/8/2024
Although veterinary mAbs have achieved commercial success, ongoing discussions and clinical developments surrounding them are expected to outline a clear regulatory pathway in the near future.
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Revolution In The EU Pharmaceutical Legislation Ahead
2/8/2024
Discover the impact revised pharmaceutical legislation will have on the industry by superseding regulations that have fostered the availability of safe and effective medicines for the past two decades.
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The Latest Trends In The Prevention And Treatment Of Cervical Cancer
2/8/2024
Unearth what immune checkpoint inhibitors are showing promise in treating cervical cancer and how advancements in these treatments paired with additional prevention strategies are improving patient outcomes.