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Article The Lifecycle Change of Process Validation and Analytical Testing
The 2011 guidance aligns process validation with product lifecycle principles that are now part of current regulatory thinking and principles.  CHALLENGES   BioPharm: What are the key…

Article Sterilization Trends for Single-Use Consumables
The first step in establishing an effective sterilization process for SU consumables, according to James Hathcock, senior director of regulatory and validation strategy at Cytiva, is to select a steri…

Article Digitalization: The Route to Biopharma 4.0
By transforming data into an intelligence-supporting decision-making tool, it is easy to realize the longstanding regulatory initiatives of process analytical technology (PAT) and quality by design (Q…

Article Ensuring Viral Safety of Viral Vaccines and Vectors
However, because achieving robust clearance is challenging using chromatography, regulatory documents urge caution but remain encouraging. European guidance states that if the virus reduction is repro…

Article Understanding Validation and Technical Transfer, Part 3
This information serves as the foundation for producing material for clinical studies, initial regulatory filings such as investigational new drug applications (INDs) and biologics license application…

Article Putting Viral Clearance Capabilities to the Test
When applying for regulatory approval, a drug license holder must demonstrate that its proposed manufacturing process can remove or inactivate potential viral contaminants. Viral clearance studies…

Article Understanding Validation and Technical Transfer, Part I
It is not a stack of protocols and reports designed to satisfy regulatory expectations. It is not following by rote a series of “qualifications” such as design (DQ), installation (IQ), operational (OQ…

Article Process Development: What May Lie Ahead in 2018?
Safety and Regulatory Concerns As scientific breakthroughs continue to advance the biopharmaceutical industry, safety issues (new and old) must also remain a top-of-mind concern for the biopharmac…

Article Transformative Medicines Challenge FDA and Manufacturers
OCP receives hundreds of inquiries on issues related to product classification, many seeking early advice on the regulatory designation process. FDA officials emphasize the importance of achieving con…

Article Patenting Prospects for Cell-Based Therapies
Accordingly, patent exclusivity will be important to defray high development and regulatory compliance costs. The nature of such therapies, and recent patent law trends regarding natural products and …

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