Search results for "biologic"
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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
Biopharmaceuticals are often complex molecules, or mixtures of molecules, produced in biological systems and it is not always possible to fully characterize these products in the laboratory. Therefore…
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N-Glycan Analysis of Biotherapeutic Proteins
…cans) to a peptide backbone, is a common post-translational modification (PTM) that imparts various biological functions (1). More than half of all biotherapeutics are glycosylated (2), including mon…
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Witnessing Major Growth in Next-Generation Antibodies
…ost 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 technologi…
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Managing Biomanufacturing Capacity Expectations
This demand underestimation is an important finding considering the large number of biologic, immune-oncology therapeutics (with various proposed indications) that are currently in the pipeline. The a…
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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
Reslizumab—Teva is gunning for FDA approval in 2016 for its biologic reslizumab (trade name Cinquil), which targets IL-5. Although the company will first seek an approval for the medication for the tr…
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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…