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 ...

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 ...

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 ...

Pharmaceutical manufacturing requires defining quality target product profiles and critical quality attributes (CQAs) to ensure desired product quality. Process development identifies critical process ...

Incorporating Q8, Q9, Q10 into good manufacturing practices (GMP), guidance on process validation, health based exposure limits covering cleaning validation and computerized system validation are the ...

FREMONT, Calif.--(BUSINESS WIRE)--Tivic Health® Systems, Inc. (Nasdaq: TIVC), a diversified therapeutics company, announced today it has entered a definitive agreement with Scorpius BioManufacturing ...

Girindus has won its second process validation contract this year. The process is for the manufacture of an oligonucleotide currently in Phase III testing. It has been granted orphan drug status and ...

(MENAFN- GlobeNewsWire - Nasdaq) This training session presents opportunities in enhancing compliance and efficiency in drug manufacturing by deepening understanding of FDA and EU guidelines, ...

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 ...