Search results for " regulatory"
Article
Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
Failing to demonstrate similarity can come at a significant cost and can trigger a more extensive (and expensive) clinical examination prior to receiving regulatory approval. Guidance documents from r…
Article
Nurturing Knowledge from Disparate Data Streams
Pharmaceutical scientists must be able to integrate and interpret these data in an efficient manner that ensures reliability, security, and regulatory compliance.
Digitalization creates difficulti…
Article
Using Multiple Techniques in Biosimilar Analysis
Whether they are called ‘sameness’ for generic drugs, ‘comparability’ for biologics, or ‘analytical similarity’ for biosimilars, these tests are crucial for any regulatory submission, which is vital t…
Article
FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
A new INTERACT program (Initial Targeted Engagement for Regulatory Advice on CBER producTs) replaces current pre-pre-IND meetings for all CBER products. The aim is to help less experienced sponsors an…
Article
The Challenge of Disruptive Technologies in Bioprocessing
…ctivity and have platformable processes for these new modalities, while meeting the high quality and regulatory standards for the therapeutic,” says Terova.
The biomolecule purification scheme…
Article
CDMOs Driving Emerging Bio/Pharma Success
…t small molecules, antibody drug conjugates, and gene and cell therapies
• A favorable regulatory environment that offers faster routes to new drug approval
• A robust equity investment…
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Leveraging Data for Better Biopharmaceutical Process Control
You need to understand the organization, its quality culture and the regulatory framework.
Leveraging soft sensors
BioPharm: Has the industry grown more comfortable with the concept of soft se…
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Biopharmaceutical Market in Asia: Q&A with Günter Jagschies, Strategic Customer Relations Leader, Cytiva
Specific topics will be the review of health challenges in Asia and future approaches to address them, creative technology solutions, facility and regulatory aspects, as well as vaccines and plasma de…
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3rd BioProcessing Asia Preview: Q&A with John Curling
… • Innovation and creative technology implementation
• Change and challenge in the regulatory environment in Asia
• Prevention rather than cure: vaccine development and manufacturing trends
…
Article
Bioburden Control in the Biopharmaceutical Industry
Hughes, “Aseptic Processing of Biological Products: Current Regulatory Issues,” presentation at the WCBP 2016 Symposium (Washington, DC, 2016).
4. CFR Title 21, 210.1-3, 211.4-31.
5. FDA, …