Dublin, Oct. 28, 2025 (GLOBE NEWSWIRE) -- The "Biopharmaceutical Manufacturing Process Validation (Nov 17th - Nov 18th, 2025)" training has been added to ResearchAndMarkets.com's offering. This ...
Regulators are modernizing their expectations, and it's become clear that validation can no longer function as a point-in-time event.
PETACH TIKVA, Israel, Sept. 19, 2023 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced ...
The Company’s presentation showcased promising early data on the viability and potency of cells from its proprietary Master Cell Bank (“MCB”). The MCB represents a valuable and key strategic asset in ...
The track by which API manufacturing processes are prepared for commercial use is comparable to overlapping integrative process evaluations at commercial scale. This ensures the process is ...
The concept of lifecycle control of manufacturing process validation (5) addressed the shortcomings of the linear approach to process validation using Stage 3–Continued Process Verification (CPV).
Laser micromachining is a versatile process that can be used for an array of medtech applications. Yet when using it, it is crucial to select the appropriate method of process qualification or ...
Pharmaceutical manufacturing requires defining quality target product profiles and critical quality attributes (CQAs) to ensure desired product quality. Process development identifies critical process ...
(MENAFN- GlobeNewsWire - Nasdaq) This training session presents opportunities in enhancing compliance and efficiency in drug manufacturing by deepening understanding of FDA and EU guidelines, ...
Completes a Substantial Requirement Toward the Planned Submission of D-PLEX 100 NDA and MAA Regulatory Filings PolyPid’s ongoing Phase 3 SHIELD II trial of D-PLEX 100 for the prevention of surgical ...
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