Search results for "biopharm"
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Single-Use and Continuous Processing Technologies Change Facility Design
In parallel, another change on the horizon in biopharmaceutical plants is continuous processing--the impact of which could be as significant in the pharmaceutical industry as it was in the car and ele…
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Applying GMPs to the BioPharma Supply Chain
Manufacturing biopharmaceuticals carries great responsibility. The drugs produced must be available when needed, effective for their intended purpose, and safe to use. At an operational level, it is v…
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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 for…
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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 (…