Search results for " biologics"
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A Look into the Future of Biopharmaceutical Quality
Regulations
BioPharm: With the fast development of the biopharmaceutical industry over the past 30 years, how have quality regulations adapted to address the complex nature of biologics?
Ne…
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Automation Trend in Fill/Finish Reduces Contamination Risk
The rise of costly biologics over the past 20 years, however, has put greater pressure on downstream fill/finish operations to ensure that quality, safety, and cost efficiency are not compromised at t…
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Understanding Validation and Technical Transfer, Part I
Understanding Validation and Technical Transfer, Part I
This is the first of a series of three articles about validation and technical transfer in the bio-pharmaceutical industry. Part 1 || Part 2 |…
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N-Glycan Analysis of Biotherapeutic Proteins
In this article, the biological effects of N-glycosylation on protein biologics are reviewed—together with the range of analytical techniques that are used to elucidate the N-glycosylation characteris…
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Witnessing Major Growth in Next-Generation Antibodies
…most prevalent technologies, according to Mike Riley, vice-president and general manager at Catalent Biologics.
The various formats can be placed into four main categories. One involves technolog…
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Managing Biomanufacturing Capacity Expectations
These findings could have implications for future demand calculations for biologics, as well as biosimilars with numerous market competitors—especially if the Centers for Medicare and Medicaid Service…
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Innovative Therapies Require Modern Manufacturing Systems
By Jill Wechsler
FDA set a 19-year record in 2015 in approving more new drugs and biologics, and agency officials expect this pace to continue. Manufacturers are testing a full pipeline of importa…
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mAbs to Watch in 2016
Clinical-trial supplies of ibalizumab were manufactured at WuXi's biologics manufacturing facilities in China for its partner, developer TaiMed Biologics, according to a WuXi press release. The drug r…
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Biosimilars Will Bring Significant Litigation and Patent Challenges
Even though one of the key objectives of the Biologics Price Competition and Innovation Act (BPCIA) is to identify and limit the number of patents that can be the subject of litigation, according to E…
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Detecting Protein Aggregates and Evaluating their Immunogenicity
The very nature of aggregation is challenging, says St John Skilton, senior global market manager of biologics at SCIEX, a life-science analytical technologies company. The fact that aggregation is “d…