April 5th 2025
The authors examine the risks of extractables and leachables, and present solutions that emphasize the importance of a strategic, multi-prong approach.
There is a great need for sensitive, precise, and easily accessible analytical detection techniques for protein sequencing.
Sterility Test Isolators for Aseptic and Toxic Drug Products are Ergonomically Designed
May 24th 2018The sterility test isolator (STISO) for testing aseptically filled drug products and for testing toxic aseptic drugs (STISOtox) from Metall+Plastic, a subsidiary of Optima, are modular and ergonomically designed.
Impact of Agitator Design on Bioreactor Performance
May 15th 2018Aerobic bioprocesses are highly dependent upon the oxygen transfer rate (OTR) from sparged to dissolved gas. The relatively low solubility of oxygen, however, makes the choice of mixer impeller configuration a critical design factor for the bioreactor vessel. This article describes a series of experiments and computational fluid dynamics (CFD) simulations to detail the effect of mixer configuration on the efficiency and effectiveness of a bioreactor vessel with respect to blend time and mass transfer.
Establishing Acceptance Limits for Uniformity of Dosage Units: Part 3
May 2nd 2018The working acceptance limits for acceptance values (AV) are determined using the critical values at, for example, 95% coverage over the corresponding AV distributions. However, validity of such limits needs to be elaborated.
Proteus is Extending the Reach of the Digital Pill
April 26th 2018Proteus Digital Health is collaborating on a pipeline of digital, oral solid-dosage drugs for various therapies, including cardiovascular and oncology drugs, based on its first NDA, which used ingestible sensors in an antipsychotic treatment.