Search results for " biopharmaceuticals"
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Challenges and Trends in Biopharma Facility Design
Reduced scale considerations such as the ability to make smaller batches of biopharmaceuticals for innovative or personalized therapies, or those for rare diseases, have all contributed to the current…
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Challenges in Analytical Method Development and Validation
The manufacture of biopharmaceuticals presents some unique challenges when ensuring product quality and patient safety. Analytical testing can provide the data needed to produce a safe and effective d…
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The Outlook for CMO Outsourcing in 2019
FDA approved approximately 25 new biopharmaceuticals in 2018 (1), and the number of annual approvals is expected to increase in coming years, as new classes of products receive approvals, particularly…
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Driving Improved Access to Biosimilars
Although approved, these drugs are not “interchangeable” with name-brand biopharmaceuticals, as that term has been defined in the US. Unlike small-molecule generics, biosimilars cannot automatically b…
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Maximum Output Starts with Optimized Upstream Processing
By Cynthia A. Challener
Biopharmaceutical companies and contract manufacturers respond to changing demand dynamics for upstream bioprocessing capacity.
Significant growth in the develo…
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Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
As work continues to extend best practices to innovative therapies, manufacturers are collaborating to bring greater understanding to existing biopharmaceuticals and their manufacturing. This article …
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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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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…
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Understanding Validation and Technical Transfer, Part I
Subsequent revisions to US and international regulations and guidance documents stressed the need for process validation and quality management systems to ensure pharmaceuticals and biopharmaceuticals…
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Advanced Technologies Facilitate Scale-up and Technology Transfer
Single-use and modular technologies plus continuous manufacturing are increasingly important to biopharma scale-up and tech transfer.
Jun 01, 2015
By Cynthia A. Challener
BioPharm Inte…