Search results for " production" in Articles / App Notes
Article
Drug Quality Key to Innovation and Access
Similarly, modern, agile, and reliable production systems that adhere to standards and ensure data integrity are vital for development and access to biosimilars, cellular and gene therapies, complex d…
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Biopharma Advances Demand Specialized Expertise
BioPharm: What are the prospects for continuous manufacturing to be firmly established in bioprocessing? What are the roadblocks to implementation?
Lorimer (Patheon Biologics): Continuous productio…
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Detecting Protein Aggregates and Evaluating their Immunogenicity
Mar 01, 2015
By Randi Hernandez
BioPharm International
Volume 3, Issue 28
Aggregation in biopharmaceuticals remains a major concern and threatens the stability of a product. Protein …
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Elucidating Biosimilars Characterization
The global market for biosimilar drugs has been forecasted to be $2.445 billion in 2013 according to a report by the British market-research firm, Visiongain (1). The growth corresponds to a …
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Supply Chain Challenges for Single-Use Systems
In September 2018, MilliporeSigma announced its first Mobius single-use manufacturing facility in Wuxi, China would begin production in 2019 (2), and in November 2018, Cytiva announced a collaboration…
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FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
It’s “not simple” to bring a clinical production process to commercial scale, he says, voicing fears that important manufacturing issues could hinder efforts to advance new discoveries able to transfo…
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CoAs Help Secure the Supply Chain
CoAs Help Secure the Supply Chain
Certificates of analysis can be used to monitor the reliability of products and their suppliers.
By Susan J. Schniepp, distinguished fellow at…
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The New World of Biopharmaceutical Manufacturing
Companies are implementing end-to-end single-use platforms for monoclonal antibody, antibody drug conjugate, and vaccine production. Flexible facilities are likely to become an important part of large…
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From Darwin to Recombinant Fc Multimers
While not all questions could not be answered in this public forum, press releases already revealed that Creat will invest £100 million in BPL to expand production capacity. Perkins expected more merg…
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Witnessing Major Growth in Next-Generation Antibodies
Including next-gen antibodies in pharma pipelines is considered essential for future success.
By Cynthia A. Challener
Next-generation antibodies are designed to be more specific and are ofte…