Search results for " Biopharm" in Articles / App Notes
Article
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
Identifying CQAs for a biotech therapeutic is the first and arguably the most difficult step in implementation of quality by design (QbD) for development and production of biopharmaceuticals (3, 4). …
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FDA Urged to Preserve Biosimilar Naming Conventions
The Generic Pharmaceutical Association (GPhA) is reporting that 32 organizations, including pharmacies and labor unions, have signed a letter urging FDA to require biologics and biosimilars to have …
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Concentrating Feed—an Applicable Approach to Improve Antibody Production
Recombinant protein production in the biopharmaceutical industry mostly relies on fed-batch mammalian cell culture (1, 2). Often in fed-batch processes, the feed volume can be more than 1000 L for a 5…
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Bureaucratic Roadblocks Threaten Biopharma Growth
This is particularly true in knowledge-intensive sectors such as biopharmaceuticals.
The good news is that some mature and emerging economies are making growing use of patent systems to facilita…
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Biopharma Takes a Nervous Glance Over Its Shoulder
The US biopharmaceutical industry’s status as the global leader in innovative biopharmaceutical R&D is not guaranteed. Both R&D and manufacturing could shrink or shift to other countries if the busine…
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Raw Material Variability
Sometimes the supplier is a big company selling materials to many industries and biopharmaceutical manufacturing is a small part of their overall business. In this case, their willingness to help coul…
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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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Biopharma Outsourcing Activities Update
Virtually all of the others, however, are being outsourced by fewer biopharma respondents this year.
The following are some notable changes found in this year’s study:
Fill/finish operations (…
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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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Manufacturers Struggle with Breakthrough Drug Development
Accelerated testing and production create challenges in documenting product quality.
Biopharmaceutical companies are eager for FDA to designate potential test therapies as “breakthrough drugs…