Colombian and Mexican GMP certifications expected during Q1'21 and Q2'21, respectively The Company confirms that its recently completed Processing and Extraction Center at its Rionegro facility, ...

NEW YORK--(BUSINESS WIRE)--Regulatory News: Cellectis (Paris:ALCLS) (NASDAQ:CLLS) (Alternext: ALCLS – Nasdaq: CLLS) today announced that a series of three production runs of UCART19, its lead TALEN ® ...

Small biotechs in early development of cell therapies are often surprised by the strictness of commercial manufacturing standards. That’s the view of Luděk Sojka, PhD, CEO of contract developer and ...

Main opportunities include integrating process validation with modern, science-based approaches, utilizing risk-based strategies like QbD, DOE, and PAT, and adhering to global regulatory standards to ...

Eurofins CDMO Amatsiaquitaine S.A.S., the GMP manufacturer, to support Polyrizon in future commercialization efforts Raanana, Israel, Jan. 23, 2025 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (PLRZ) (the ...

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. The Therapeutic Goods Administration (TGA) of Australia has released guidance and a web-based tool to ...

Australia’s Therapeutic Goods Administration (TGA) has revised its process for handling the closeout of on-site good manufacturing practice (GMP) inspections. The updated process ends the practice of ...

Cannabis company Flora Growth Corp. FLGC announced Tuesday that its wholly-owned subsidiary, Cosechemos, has produced the first batch of crude oil through its newly constructed extraction facility.

All health products registered with the Health Ministry must have a valid MAL registration number or hologram security label.

Eurofins CDMO Amatsiaquitaine S.A.S., the GMP manufacturer, to support Polyrizon in future commercialization efforts Raanana, Israel, Jan. 23, 2025 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (the "Company" or ...