Our teams, backed by 50+ years of experience and a proven track record of excellence, optimize, adapt, and perfect innovative technologies and drug substance development approaches to deliver world-class solutions for pharmaceutical manufacturing. We thrive on the vexing challenges few CDMOs would hav...
Our Blog features regular News of chemistry, manufacturing and controls (CMC) of pharmaceutical products, Biologics, and Drug Development
Our Blog features regular News of chemistry, manufacturing and controls (CMC) of pharmaceutical products, Biologics, and Drug Development
Study Phase by Lead Product Company by Lead Product Top Deals by Deal Size (USD bn) 01 HCW Biologics U.S.A Biotech Showcase Not Confirmed 02 HCW Biologics U.S.A Biotech Showcase Not Confirmed 03 HCW Biologics U.S.A Biotech Showcase ...
Product Type Dosage Form Lead Product Target Therapeutic Area by Lead Product Study Phase by Lead Product Company by Lead Product Top Deals by Deal Size (USD bn) 01 Chime Biologics China Duphat Not Confirmed 02 Chime Biologics China Duphat ...
From initial characterization of drug substance to commercial batch release, each phase of your drug product development requires analytical methods to qualify the product for safety, integrity, strength, purity, and quality. With these critical attributes in mind, Alcami’s biologics analytical developme...
Kingham R, Klasa G, Hessler Carver K. Key regulatory guidelines for the development of biologics in the United States and Europe. In: Wang W, Singh M, editors. Biological drug products: development and strategies. 1st ed. Hoboken, New Jersey: John Wiley & Sons, Inc.; 2014....
A global contract development manufacturing organization (CDMO/CMO) offering development & manufacturing for protein expression biologics, pDNA, mRNA, viral vectors (AAV, LVV, RVV) and genetically engineered cells.
WuXi Biologics announced that its two Drug Substance facilities and a Drug Product facility located in Wuxi city received regulatory approvals from the European Medicines Agency and the U.S. Food and Drug Administration.
the structure-function relationship of drug delivery systems based on cell-penetrating peptides, lipid nanoparticles and polymeric colloidal, and biophysical and biochemical stability of peptide, protein, monoclonal antibody, and vaccine, as the integrative efforts on drug product design, will be ...