The company received a complete response letter from FDA in response to the biologics license application for a proposed trastuzumab biosimilar. / read more /
Research from Gladstone Institutes suggests that transplanting genetically altered interneurons could improve cognitive function for Alzheimer's disease. / read more /
FDA sent a warning letter to Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd. for failure to follow current good manufacturing practices. / read more /
The agency updated its list of recommended influenza virus strains that manufacturers should include in vaccines for the autumn 2018 season. / read more /
Proteus 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. / read more /
The authors discuss expectations of regulators on the selection of drug substance regulatory starting materials (RSM) and the justification of their designation in the pharmaceutical supply chain, the scope of the RSMs' presentation required in regulatory filings, and how to mitigate and prepare for "push backs" in the event of a major objection to the sponsor's RSM designation. / read more /
The study describes a methodology to establish, control, and characterize an aerosolized bioburden within a test chamber and determine the settling rate of the bioburden. The intention of this article is to stimulate the necessary discussion for the establishment of the standard criteria for all aerosol tests to generate comparable and reproducible data. / read more /
Aston Particle Technologies has developed a technology that produces functionalized particles in a one-step, environmentally friendly process. / read more /
SMA MicroParticle ICSTM
VAI is pleased to announce the addition of the SMA MicroParticle ICS line of non-viable particle counters that utilize the latest innovation in particle counting technology, to our contamination control portfolio. / Read more/
Vaccines—from childhood and influenza immunizations, to epidemic prevention, to cancer and therapeutic treatments—present unique development challenges. In this Vaccine and Manufacturing eBook, the editors explore development and manufacturing options to make vaccines more accessible.
