Initiative, together with the Broad Institute of MIT and Harvard, aims to accelerate efforts to mine genetic data for insights into disease mechanisms.
The importance of reagent quality control, especially endotoxin testing, during CGT development and the selection of reagents and suppliers to ensure safety.
Garrett Perry, Technical Services Specialists at Teknova09.14.21
Spray drying is an established particle engineering technology that offers several advantages over other methods used for improving API bioavailability.
Dendritic cell vaccine production capacity for personalized immune therapies increases from about 4 - 6 patients per month to about 40 - 45 patients per month.
John Mosack head GMP mfg. at Baltimore site; Adam Sachs to lead program mgmt. and client alliance; Deborah Wild is chief quality and reg. affairs officer
New drug product manufacturing facility in Waigaoqiao Free Trade Zone of Shanghai has passed its first GMP inspection by the European Medical Products Agency
Gains licenses for manufacture, downstream processing into capsules and tablets, as well as spray dried formulations of biotherapeutics and small molecule APIs
What level of GMP need to be followed for clinical trial materials (for a generic ANDA) intended for animal studies if the drug is already in the market?
Labtec GmbH, a subsidiary of tesa SE, has opened its new GMP manufacturing facility for transdermal drug delivery systems (TDS) and oral dispersible films (ODF) employing its RapidFilm technology.
ICON has opened a purpose-built clinical pharmacology unit in the Central Manchester University Hospitals Foundation Trust (CMFT) campus in Manchester, UK.
Azopharma Drug Development Services has received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) for production of commercial product.
Laureate Pharma and Iconic Therapeutics, a developer of ophthalmic products, have completed the manufacture of the first GMP lot of hI-con1 recombinant Fc-Factor VII fusion protein for the potential treatment of macular degeneration and other diseases.
Novozymes Biopharma's Recombumin and albucult products are the first to comply with the new excipient monograph standard for recombinant human albumin, published in the U.S. Pharmacopoeia - National Formulary (USP-NF). First
Sinovac Biotech Ltd. has received GMP certification from the Chinas State Food and Drug Administration (SFDA) for its filling and packaging production facility.