Search results for " biopharmaceutical" in Articles / App Notes
Article
DoE Provides Benefits, but Preparation Is Necessary
An added benefit of this efficiency, Yang notes, is the reduced quantity of material needed for formulation development, which can be important early in the development of a biopharmaceutical product …
Article
Single-Domain Antibodies for Brain Targeting
With 25 mAb products on the market and more than 100 undergoing clinical trials (1-3), it is evident that engineered antibodies have come of age as biopharmaceuticals (4).
Intact antibodies (immun…
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Quality by Design—Bridging the Gap between Concept and Implementation
… by EMA, included real-time release testing (RTRT), application of QbD to continuous manufacture and biopharmaceutical production, dealing with post-approval changes to QbD processes, and the need fo…
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Trends in BioPharma Approvals in 2013
A total of 16 approvals were recorded in Europe, while only six biopharmaceuticals came on the market in the US in that same period. This trend can partly be explained by Europe playing catch up in th…
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Q&A with Industry Leaders: Rita Peters
With additional product lines through acquisition or innovation, many suppliers emphasized capabilities of providing end-to-end technologies, equipment and support to the biopharmaceutical manufacturi…
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Best Practices in Adopting Single-Use Systems
The adoption of single-use systems in biopharmaceutical production originated with the desire to minimize cleaning and associated validation. Before long, bioprocessors recognized the value of flexibi…
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Bioprocessing Advances in Vaccine Manufacture
Single-Use Adoption
BioPlan's 10th Annual Report documents increasing adoption of these technologies and their impact on biopharmaceutical manufacturers. Survey data show that bioprocessing at pre…
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Milestones and Moderate Progress in 2012 Drug Approvals
Twelve biopharmaceutical marketing applications were approved in the United States and/or the European Union in 2012 (see Table I). Approval numbers for the past year are in line with those recorded o…
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Advancing QbD in the EU
EU authorities are stepping up their efforts to incorporate QbD principles.
The European Commission (EC) and the European Medicines Agency (EMA), have been supporting quality-by-design (QbD)…
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PDA's Technical Report for Biotech Cleaning Validation
Cleaning validation plays an important role in reducing the possibility of product contamination from biopharmaceutical manufacturing equipment. It demonstrates that the cleaning process adequately an…