Search results for " regulatory"
Article
Making the Move to Continuous Chromatography
Some regulatory aspects must still be addressed, however, and for companies with extensive existing infrastructure, switching to continuous chromatography might not be cost-effective.
Continuous v…
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Applying GMPs in Stages of Development
I work in the quality and regulatory departments of a contract manufacturer. We have clients with products in various stages of development that are using multiple contracts with multiple services pro…
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Manufacturing Standards Key to Advancing Cellular and Gene Therapies
Such advances, though, require further clarification of regulatory policies governing gene therapy production and quality assurance.
FDA is considering at least three CAR-T applications, and mo…
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Avoiding Investigational Failures and Discrepancies
By Walt Murray, James Jardine
Investigations-focused regulatory standards that apply to life-sciences organizations, such as FDA 21Code of Federal Regulations (CFR) 211.192, mand…
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Managing Residual Impurities During Downstream Processing
“They are intended,” he adds, “to support and complement regulatory assessment and could be applied throughout the product lifecycle.” USP sets public quality standards and FDA enforces such standards…
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Speed and Flexibility Are Dual Goals for Biopharma Operations
What are some challenges in bringing new manufacturing technologies to commercial operations?
Developing a process to produce a biologic-based drug—and gaining regulatory approval for that process…
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Innovative Therapies Require Modern Manufacturing Systems
CDER further aims to encourage manufacturer adoption of cutting-edge pharmaceutical production technology by providing assistance in meeting regulatory requirements for innovative systems. A draft gui…
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GMP Challenges for Advanced Therapy Medicinal Products
They lack the regulatory expertise and resources to establish and operate GMP-compliant manufacturing processes. In particular, they often do not have adequate systems in place for evaluating the qual…
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Modular Manufacturing Platforms for Biologics
…titive advantage, especially in crowded therapeutic markets where similar products are in a race for regulatory approval. Emel writes on CRB’s website, “Being able to compress project schedules also …
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Drug Discovery and Development in India
Changes in the regulatory environment in the same year led to other developments with the emergence of the country as a favorite destination for “chemistry” outsourcing followed by “collaborative drug…