News & Analysis on Clinical Trial Services & Contract Research And Development
Goodwin Biotechnology has teamed up with Coldstream Laboratories to offer clients ADC services as another example of biopharma demand driving contract manufacturing and development.
Dispatches from Excipient Fest in Baltimore
China’s implementation of GMPs for excipient manufacturers, as well as a developing US FDA-style DMF system, have added another layer of safety requirements but challenges remain for the regulators in ensuring compliance, experts say.
Dispatches from Excipient Fest in Baltimore - UPDATE
As the USP, ICH and US FDA all aim to tackle elemental impurities testing for pharmaceuticals and excipients, questions still remain on whether the manufacturers will be able to comply with the looming requirements.
Live From Interphex in New York City - Updated
Following the completion of remediation efforts to deal with an FDA warning letter, Chris Phillips, AMRI's senior director of its Burlington, Massachusetts site, discusses what he considers to be a "new bar" in enforcement activity from the agency since...
Updated
New auto-injector technology that is user-friendly and capable of delivering high viscosity drugs may be the next big thing for pharma and biotech companies pushing further into niche biologics and biosimilars.