Search results for " development" in Articles / App Notes
Article
Putting Viral Clearance Capabilities to the Test
…n model using appropriate model viruses,” says Kate Smith, principal scientist, global operational development services, MilliporeSigma. “The study should be carefully designed to ensure the capacity…
Article
Manufacturing Standards Key to Advancing Cellular and Gene Therapies
More than 100 experimental chimeric antigen receptor T-cell (CAR-T) therapies are in development, generating optimism that regenerative medicine will transform treatment and lead to cures for many dea…
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N-Glycan Analysis of Biotherapeutic Proteins
…te (CQA), making the characterization of N-glycan structures an essential part of the biotherapeutic development process. The complex, branched structure of N-glycans present a unique analytical chal…
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CMOs Concerned With Cost of Single-Use Equipment
Suppliers indicate prices for single-use equipment are likely to increase.
By Eric Langer
Contract manufacturing organizations (CMOs) have been enthusiastic adopters of single-use technologi…
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Advanced Technologies Facilitate Scale-up and Technology Transfer
With this approach, data that are representative of large process behavior can be collected early in the development process and at lab-scale costs, according to Galliher. He adds that better-designed…
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Use of Multivariate Data Analysis in Bioprocessing
In this 33rd article in the “Elements of Biopharmaceutical Production” series, the authors review major developments in use of MVDA in bioprocessing applications that have occurred in the past five ye…
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Ensuring the Quality of Biologicals
moved into the 21st Century, it increased its activity in the biological field to address increasing numbers of biologicals and challenges driven by development of biosimilar products.
Pharmacopei…
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Securing the Single-Use Supply Chain
Single-use systems (SUS) have become established in biopharmaceutical drug development. As confidence in the technology has increased, the adoption of disposable equipment for commercial manufacturing…
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New Era for Generic Drugs
Generic drugs now account for more than 85% of US prescription drug use, and the development of biosimilars promises to extend this trend to large molecules. Such transformation was unanticipated back…
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Continued Process Verification for Biopharma Manufacturing
…a biopharma manufacturing process might be implemented and explaining the thought process behind the development of a CPV plan (2). Its recommendations are based on a typical cell culture production …