Search results for " biopharms" in Articles / App Notes
Article
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
An approach for establishing the CQAs of a mAb product by evaluating impact and uncertainty during risk assessment.
A critical quality attribute (CQA) has been defined as “a physical, chemical, …
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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
In this study, the authors evaluated different approaches to prepare highly concentrated feed media for fed-batch Chinese hamster ovary cell culture. By raising the pH or by adding surfactants, the fe…
Article
Bureaucratic Roadblocks Threaten Biopharma Growth
Protecting intellectual property rights is vital to biopharmaceutical innovation.
There is a clear link between a country’s rate of economic development and the strength of its intellectual p…
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Biopharma Takes a Nervous Glance Over Its Shoulder
Changes are needed to maintain US biopharma innovation leadership.
The US biopharmaceutical industry’s status as the global leader in innovative biopharmaceutical R&D is not guaranteed. Both…
Article
Raw Material Variability
The biopharmaceutical industry is developing a new approach to controlling variability in raw materials.
It would seem that raw materials used in bioprocessing operations are a relatively straig…
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Quality by Design—Bridging the Gap between Concept and Implementation
The drive to embed quality-by-design (QbD) principles into the pharmaceutical regulatory framework of the European Union has reached a key point 10 years after the European Medicines Agency (EMA) firs…
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Biopharma Outsourcing Activities Update
Outsourcing activity remains strong and unlikely to abate, especially in more traditional areas.
Over the past 11 years, BioPlan’s annual report and survey of biopharmaceutical manufacturing ha…
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Q&A with Industry Leaders: Rita Peters
This week, Process Development Forum's new Q&A feature interviews Rita Peters, Editor of BioPharm International Magazine, about second quarter trends in drug development.
Q: What trends have yo…
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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…