Search results for " Biopharm"
Article
Advancing Single-Use Technology Through Collaboration
By Cheryl Zigrand
The use of disposable, single-use components within the biopharmaceutical manufacturing process is not a new phenomenon. Silicone tubing, capsule filters, tissue culture flasks, …
Article
Framing Biopharma Success in 2016
Peters
The US biopharmaceutical industry turned a new page in 2015 when FDA approved Zarxio (filgrastim-sndz), the first biosimilar approved for use in US markets, in March 2015. Biotechnology sto…
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Biosimilars Will Bring Significant Litigation and Patent Challenges
… will still be the subject of significant litigation in years to come, she said in an interview with BioPharm International.
Pre-litigation steps for biologics has been set out by the BPCIA, wher…
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SEC in the Modern Downstream Purification Process
A recent trend in biopharmaceutical manufacturing is disposable or single-use technologies. If vaccine manufacturing becomes decentralized to locations throughout the world, as current trends imply, d…
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Viral Clearance Challenges in Bioprocessing
Challener is a contributing editor to BioPharm International.
Article
Setting Standards for Biotech Therapeutics in India
With the ongoing shift from small molecules to biologics, the Indian biopharmaceutical industry is also set to replicate the success received by the Indian pharmaceutical companies (Figure 1B) (1). Th…
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 …
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Application of Quality by Design to Viral Safety
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The biotech industry has begun to implement a quality-by-design (QbD) approach to ensure the quality of biopharmaceuticals. Using this approach, products are developed with a thorough under…
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Challenges of Protein Aggregation During Purification
Barrett adds that it has been recently found by some biopharmaceutical manufacturers that the addition of copper at the cell-culture stage leads to a significant reduction in aggregation downstream, a…
Article
2014 Manufacturing Trends and Outlook
In a recent survey of current trends and practices in biopharmaceutical manufacturing, BioPharm International readers revealed a preference for disposable systems, identified challenges for different …