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.
Will leverage integrated services from Selexis and KBI as part of Immatics’ development of TCR Bispecifics, designed to detect, target and attack tumor cells.
Supports Mirus’ expansion of GMP production of its flagship product TransIT VirusGEN for large scale manufacturing of AAV and LV viral vectors for gene therapy.
Lonza’s Robert Beland discusses best practices for manufacturers to shorten development timelines, as well as some of the capabilities at the CDMO's Tampa site.
ProBioGen to provide cell line development, process development and GMP manufacturing at 1000 L bioreactor scale of Asher's lead immuno-oncology candidate.
Recognizes manufacturing facility and processes are in compliance with GMP requirements and readiness to provide commercial aseptic fill/finish services.
To show the impact to autologous and allogeneic cell therapies by integrating novel transfection technology with other steps in the manufacturing process.
Will increase 7000L drug substance capacity (MFG21) and drug product capacity (DP11) for liquid and lyophilization within its global manufacturing network.
Dendritic cell vaccine production capacity for personalized immune therapies increases from about 4 - 6 patients per month to about 40 - 45 patients per month.
Instead of closing its doors on China, Western pharma industry needs to take a balanced approach and perform proper due diligence based on objective criteria.
ProBioGen is conducting cell line development, process development and GMP manufacturing of the mAb intermediates of Heidelberg’s ATAC molecules for cancer.
Karen will work to further expand the company's contract manufacturing business, which delivers GMP materials to third parties developing COVID-19 vaccines.
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.