Novartis licenses Abogen's mRNA-encoded T-cell engager for autoimmune disease, raising scale-up questions for mRNA-lipid nanoparticle manufacturing.
News|Articles|April 2, 2005
- Pharmaceutical Technology-04-02-2005
- Volume 29
- Issue 4
Analytical Methods Validation In-Process Control Methods for the Manufacture of Active Pharmaceutical Ingredients
The authors propose a strategy for classifying and validating inprocess testing methods.
Advertisement
Articles in this issue
over 21 years ago
April 2005over 21 years ago
Management Controls for GMP Complianceover 21 years ago
PAT and Process Understanding: A Call to Armsover 21 years ago
Cold Chain Concernsover 21 years ago
Evolutions in Direct Compressionover 21 years ago
X-ray Microtomography of Solid Dosage Formsover 21 years ago
Orient ExpressAdvertisement
Related to this article
Ron Scarboro, Azurity Pharmaceuticals, explains why real-world usability belongs at product definition and how post-launch feedback should guide drug formulation.
Gene manufacturing platforms, patient-centric formulations, contract services, packaging innovations, and sterile filling lines are in the spotlight at CPHI Milan 2026.
Content on PharmTech.com this week ranged from fundamentals on the use of digital pathology in drug development, discussions on the use of AI in pharma, and regulatory actions impacting the industry.
The FDA approves Lilly's once-weekly insulin efsitora for type 2 diabetes, raising Fc-fusion manufacturing, high-concentration pen, and capacity questions.
The agency issued a direct final rule that supports the use of innovative testing methods to limit the use of animals and maintain existing safety standards.
The FDA approves Inluriyo-Verzenio combo for ESR1-mutated breast cancer; EMBER-3 data double PFS, with supply chain and diagnostics implications for manufacturers.
This week, the FDA opened applications for its Expedited IND Pilot, quality experts presented at the PDA/FDA Joint Regulatory Conference, and Hovione expanded its spray drying capacity.
Advertisement
Advertisement