Search results for " industry"
Article
Reducing Cross-Contamination Risks in Process Chromatography
To address the industry need for continuous processing, MilliporeSigma acquired Natrix Separations, a provider of hydrogel membrane products for single-use chromatography. The company has also impleme…
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Manufacturing Standards Key to Advancing Cellular and Gene Therapies
…ate partnership with a group related to the Alliance for Regenerative Medicine (ARM) to advance such industry-wide standards.
FDA’s Oncologic Drug Advisory Committee meeting on July 11, 2017 …
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Avoiding Investigational Failures and Discrepancies
Historically, corrective actions and preventive actions (CAPAs) have been overused industry-wide as a part of the investigation process within the overall quality event management scheme. Even industr…
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Improving Process-Scale Chromatography
“Initially, many people in the industry expected disposables to be less environmentally sound than traditional technologies, but our studies have revealed the opposite,” she observes. Most notably, si…
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Defining Risk Assessment of Aseptic Processes
In September 2004, FDA finalized their guidance for industry titled Sterile Drug Products Produced by Aseptic Processing-Current Good Manufacturing Practice (1).
This document placed considerable e…
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Managing Biomanufacturing Capacity Expectations
…operations, and increased modularization of production systems were identified as the top things the industry must do to avoid further capacity restrictions at biomanufacturing plants (Figure 1). Ana…
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Adherent Cell Culture in Biopharmaceutical Applications: The Cell-Detachment Challenge
The successful development of biopharmaceuticals produced from animal cell culture and other applications of adherent cells in the biopharmaceutical industry has spurred research on alternative cell-d…
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Antibody Production in Microbial Hosts
Rathore, Jyoti Batra
The biopharmaceutical industry is growing exponentially, driven by an ever-increasing demand for monoclonal antibodies (mAbs) and related products that are capable of treating…
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Biopharma in 2015: A Year for Approvals and Innovations
Twenty approvals (39%) went to biological drugs—up from 35% in 2014 and 22% in 2013—which confirms the growing importance of biopharmaceuticals in the industry pipeline.1
Process Development Forum …
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USP Stresses Pharmacopeial Standards at CPhI China
Topics included global harmonization with industry standards and regulations, compliance monitoring, and accountability. The USP requirements for elemental impurities, FDA’s metrics program, and the g…