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Drug Substance Articles & Analysis
42 news found
Before a new drug enters the market, its manufacturers would voluntarily submit drug master files (DMFs) to regulatory agencies like FDA. ...
Boston: Microneedle technology, driven by high demand in dermatologic procedures and its versatile applications in drug delivery, vaccine administration, and disease diagnostics, faces challenges in its complex manufacturing process. Ongoing research and numerous products in development make this market dynamic for newcomers entering the field. “According to the latest BCC Research study, ...
These new technologies, including drug half-life extension technologies, injection site drug reservoir technologies, and drug physicochemical enhancement technologies, offer new possibilities in the treatment of many chronic diseases. ...
Innovations in manufacturing processes, more complicated formulations, and increasingly complex global supply chains are just some of the factors making it more difficult for companies to assess and control impurities in drug substances and drug products. BOC Sciences is confident to employ its custom manufacturing capabilities and make ...
CD Formulation’s cGMP-compliant laboratory is well-equipped to identify both the chemical and structural composition of each drug substance. More recently, the company announced to broaden its service range to tablet fragility test, dissolution test, and disintegration test. ...
” CONCLUSION Next steps include receiving the Quantoom’s NtensifyTM midi system in Afrigen, and etherna’s proprietary lipid to enable Afrigen to replicate the production of mRNA drug substance and drug product according to Quantoom and etherna’s processes, respectively. ...
ByeTheRNA
“In the beginning, people may view pharmaceutical analysis as analytical chemistry dealing with drug substances and pharmaceutical products, but in fact, analytical chemists are involved in many more studies, including the analysis of the chiral purity and quality of pharmaceutical formulations, drug quality control as well as ...
Impurity identification is the process of using various analytical techniques to elucidate the identity of unknown substances in pharmaceuticals, medical devices, combination medicinal products or consumer products. ...
BySTEMart
Scandinavian Biopharma continues to strengthen its organization in manufacturing and is pleased to welcome Anna Sumic as our new DS & DP Manufacturing Specialist. Anna has a Master of Science in Chemistry and Chemical Engineering from KTH, Royal Institute of Technology, with 15 years of experience within the pharmaceutical industry. She is joining us from AFRY, a consulting company, where ...
“Chief among these was the RubrYc asset acquisition, which provides us with a differentiated, AI-powered drug discovery platform and four promising new candidates to go along with our lead asset, IBIO-101, an IL-2 sparing anti-CD25 antibody. ...
The company operates three state-of-the-art facilities for the production of biologic drug substance, which addresses a critical gap in the value chain of Fresenius Kabi. ...
“Pharmaceutical formulation development is an indispensable step that makes the new drug substance being discovered gradually develop into a commercial drug product,” commented a senior scientist from CD Formulation. The scientist responsible for drug formulation must determine the most appropriate administration ...
We know that a drug substance is usually more stable by itself than in a formulation with excipients. Inappropriate dosage forms can interact with drug substances and in worst cases can even cause drug degradation,” says the Marketing Chief of CD Formulation. ...
The rapidly dissolving yarn is a key element in the innovative EsoCap system which enables local placement of drug-loaded films and targeted, long-lasting drug delivery in the esophagus (Rosenbaum et al., Pharmaceutics 2022, 14, 1229). ...
The experts discussed the role of EsoCap’s technology for the topical treatment of Barrett esophagus and explored the application of EsoCap’s drug delivery platform in combination with monoclonal antibodies, siRNA-based technology, oncology drug substances as well as other agents. ...
To ensure the safety and efficacy of the drug product, chemical stability is of paramount importance. Earlier this month, CD Formulation announced its decision to launch forced degradation studies to help researchers find ways to promote drug stability. The forced degradation study, also known as stress testing, is carried out to produce representative samples ...
” Julie Cherrington PhD, Chair, Board of Directors Julie is an accomplished life science executive with extensive insight in bringing drugs into the clinic and through to commercialization. She has been a key contributor to the successful development of multiple FDA-approved products, including SUTENT®, PALLADIA®, VISTIDE®, VIREAD®, and HEPSERA®. ...
VeriSIM Life (VeriSIM), the leading artificial intelligence (AI)-enabled, unique R&D decisions de-risker for breakthrough drug development, announced today it has been awarded a $312,310 grant from the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH), to fund AI-driven development of medications for ...
Attempts to drug bilirubin have been made, but have failed each time. This is because of the insoluble nature of bilirubin in water. The anti-war drama was written by a domestic bio company, Vilix. It was the first successful drug substanceization by dissolving bilirubin in water. Kim Myung-rip, CEO of Vilix (pictured), said on the 16th, "We ...
G-CON, the leader in off-site prefabricated, flexible cleanroom solutions, today announced its capabilities to manufacture and deliver the company’s signature standardPOD cleanrooms in Europe. standardPODs, launched in the U.S. in 2020, are off-the-shelf cleanrooms designed to maximise efficiencies related to production, qualification, delivery and cost reduction and provide timeline ...