Search results for " industry" in Articles / App Notes
Article
Optimizing Resin Performance with Disposable Chromatography Solutions
…see growth? In what areas?
Royce and Lundström (Cytiva): The highly regulated biopharmaceutical industry does not tend to adopt new technologies quickly and, as with any novel technology, it take…
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Continued Process Verification for Biopharma Manufacturing
Preparation of the CPV plan has provided a basis upon which to build and share knowledge and initiate further clarifying discussion across the industry.
What is Continued Process Verification?
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Relationship Building at Top of Mind for Clients
Indeed, when BioPlan surveyed 238 industry decision-makers from around the world about the critical issues they consider when selecting a CMO, a leading 71% said it was ‘very important’ that they be a…
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Single-Use and Continuous Processing Technologies Change Facility Design
Facilities in use today and built during the past decade would easily be recognised by the original engineers who started this industry in the mid-1970s, whereas facilities designed now are beginning …
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Global Expansion Shapes Drug Oversight
Few FDA officials discuss pharmaceutical regulation these days without reference to how the international reach of the biopharmaceutical industry has altered drug research, production, and regulation.…
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Raw Material Variability
The industry is now developing an additional approach, which seeks to make the external inbound raw material supply chain fit for purpose. At a recent BioPhorum Operations Group meeting, 17 companies …
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Outsourcing Trends in Biopharmaceutical Manufacturing
The biopharmaceutical industry is changing the way it manufactures. According to BioPlan Associates’ 10th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production (1), outso…
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Early Communication with Regulators is Essential for SMEs
EMA stresses that in its efforts to forge closer ties with SMEs, it is not trying to undermine the position of consultants and other experts in the pharmaceutical industry. Its role is not “to substit…
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Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
As the pharmaceutical industry tries to embrace the methodologies of quality by design (QbD) provided by the FDA’s process validation (PV) guidance (1) and International Conference on Harmonization (I…
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A Look Ahead at BioPharma Manufacturing and Regulation
What does FDA and the industry hope to gain by focusing on these areas?
FDA: FDA is responsible for protecting the consumer through the availability of quality products. These approaches fo…