AI accountability, faster FDA pathways, rare disease CMC review, and next-gen GLP-1 formulation lead this week’s PharmTech roundup.
|Articles|July 22, 2016
PTSM: Pharmaceutical Technology Sourcing and Management
- PTSM: Pharmaceutical Technology Sourcing and Management-08-03-2016
- Volume 11
- Issue 8
CSafe Opens Facility in Puerto Rico
Author(s)Pharmaceutical Technology Editors
The company opened a new service center in San Juan, Puerto Rico.
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On July 18, 2016, CSafe Global announced that it has opened a new service center in San Juan, Puerto Rico. The company procured multiple 747F charter aircrafts to move multiple CSafe RKN ULDs to the facility. According to CSafe, the containers will be used to support the country’s global manufacturing industry. CSafe’s passive and small active solutions will also be available for use at the new Puerto Rican Facility.
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Articles in this issue
about 10 years ago
Slower Bio/Pharma Investment Could Hurt CDMOs in 2017about 10 years ago
Supply Chain Partner Scrutiny Moves Beyond GMPsabout 10 years ago
Chiral Advances Demonstrate Promise for API Synthesisabout 10 years ago
NIST Issues mAb Reference Standardabout 10 years ago
EMA Suspends Drugs Due to Flawed Bioequivalence Studiesabout 10 years ago
CordenPharma Expands into Oligonucleotide APIsabout 10 years ago
Shimadzu System Combines HPLC and UHPLC Methodsabout 10 years ago
Catalent to Commercially Supply Palatin FSD Pen Injectorsabout 10 years ago
Zenith Appoints Serialization DirectorAdvertisement
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Ishani Maharaj of Ingredients + Specialties from Univar Solutions explains how to stabilize GLP-1 multi-agonists, weigh delivery formats, and qualify novel excipients and suppliers.
MASH and cardiomyopathy AI collaboration: AstraZeneca pays insitro $40M upfront for target discovery, then leads clinical development and CMC planning.
Boyang Wang, Immortal Dragons, discusses how the FDA’s Expedited IND Pilot must prove efficiency as sponsors chase the fastest route to valid first-in-human data.
Nate Edwards of Arya Consulting moderates a discussion with Elisabeth Gardiner of Tevard Biosciences and Donny Xu of the RTW Institute about rare disease treatment development and navigating the FDA’s Rare Pediatric Disease Priority Review Voucher Program.
The FDA’s Rare Disease Framework Initiative brings risk-based CMC review and pre-approval inspections into scope for sponsors, CDMOs, and quality teams.
NVIDIA’s $250M, five-year compute donation funds UK agentic AI safety research, with implications for how GMP teams validate and govern autonomous AI.
Jaenisch, Muraru, and Pandey join PharmTech's Cole to discuss FDA's generative AI paper, ARPA-H's SURPASS trials, and AI accountability.
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