Search results for " guidance" in Articles / App Notes
Article
Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
EC Notices from European Union Institutions, Bodies, Offices and Agencies “Note for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary med…
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Microbiological Testing: Time is of the Essence
Pressures to accelerate current and next-gen therapies are challenging traditional microbiological testing methods.
By Cynthia A. Challener
Effective microbiological testing during biopharmace…
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Selecting a Comprehensive Bioburden Reduction Plan
FDA guidance documents, PDA TRs, and the peer-reviewed literature all provide descriptions of potential point-sources of contamination. Bioburden may be associated with personnel, incoming raw materia…
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Cleaning of Dedicated Equipment: Why Validation is Needed
International Conference on Harmonization (ICH) guidance ICH Q9 (1) encourages that a quality risk management approach be considered and that, based on the level of risk, cleaning processes may be sub…
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Robust Optimization, Simulation, and Effective Design Space
Even though there are ICH guidance documents such as Q8 and Q11 that define what a design space is, there is still a poor understanding of the meaning and application of a design space.
ICH Q8, Ph…
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Taking a “Development-by-Design” Approach to Cell Therapies
Mazzo, arguably one of few life-science company CEOs to even articulate the QbD concept, explains that the company has gone a step further, and broadened the International Conference on Harmonization …
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What’s In a Name? For Biosimilars, A Lot
This determination may ultimately factor into future FDA policy or guidance documents on biosimilar naming. While FDA and USP work closely on nomenclature policy, “USP naming is not directly implicate…
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Vaccine Development and Production Challenges Manufacturers
A Committee report (2) recommended that FDA issue guidance for manufacturers on developing new vaccine assays and adjuvants and supported efforts to devise a “universal” flu vaccine. Committee members…
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The Bullish Outlook for Biosimilars
While not formalized yet, preliminary guidance suggests that this pathway will require the comparison of a biosimilar molecule to a single reference product. Similar to other markets, head-to-head com…
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Technologies and Practices Must Evolve to Meet Demand
Barriers to implementation remain; almost half of the respondents cited a lack of knowledge or training; 39% noted a lack of clarity on regulatory guidance; more than 25% noted a lack of management bu…