Why has it taken so long, historically, to bring a new drug to market? In a word: complexity. At one end of the spectrum, there is the complexity of disease, genetic variability, the presence of environmental variables that cause patients to respond differently to the same treatment. The thread extends into clinical development, where the…
CEO of CDMO AustinPx on its exclusive agreement with Thermo Fisher’s Patheon division
Thermo Fisher’s Patheon division has signed an exclusive agreement with AustinPx to install the Texas CDMO’s KinetiSol technology at Patheon’s Bend, Oregon, and Cincinnati sites. AustinPx specializes in bioavailability enhancement for orally delivered small molecules, and the placement plugs into Patheon’s Quadrant 2 platform, which applies AI/ML to formulation prediction. It expands access to KinetiSol-enabled…
As cell therapies scale and CDMOs cut staff, process know-how is often getting lost in tech transfer
Technology transfer enables the movement of documented processes and knowledge from one unit, such as R&D, a pilot plant or an existing manufacturing site, to another, such as an internal site, CMO or CDMO. However, tacit knowledge, expertise that can’t be written down, is often lost in the process. As of 2022, over 86% of…
Sai Life Sciences plans to recruit 700+ professionals in FY27 as Indian CRDMO demand accelerates
Sai Life Sciences announced plans to hire more than 700 scientific, technical, and management professionals during 2026–27, citing growing global demand for integrated drug discovery, development, and manufacturing services. The Hyderabad-based CRDMO said the recruitment will span medicinal chemistry, biology, DMPK, process and analytical development, formulation development, process engineering, technology transfer, quality, peptides, business development,…
Cellares raises $257M Series D to automate cell therapy manufacturing
The cell and gene therapy boom is running into its manufacturing bill. Traditional production remains manual and expensive, which makes the ROI for many therapies murky at best. Venture funding in the sector has plunged more than 80% from its 2021 peak. Cellares is betting the path forward is industrial. The South San Francisco company…
Sai Life Sciences to double process R&D capacity with new Hyderabad facility
New CMC Process R&D center will add peptide and oligo-intermediate capabilities, expand analytical and formulation labs and target completion by September 2026. Sai Life Sciences plans to build a 100,000-sq-ft CMC Process R&D center at its integrated R&D campus in Hyderabad, aiming to double its process R&D capacity by September 2026. The project adds dedicated…
Sai Life Sciences exec: GLP-1 boom has ‘exploded the peptide field’ as firm opens new center
Demand for next-generation GLP-1 drugs is fueling a boom in peptide research, prompting companies like Sai Life Sciences to expand capabilities amid a hot market for obesity and diabetes treatments. “The GLP-1 agonists have exploded the peptide field,” said Maneesh Pingle, Ph.D., executive vice president and head of discovery services at Sai Life Sciences, in…
BioVectra chief commercial officer has played a pivotal role in firm’s success
Two decades ago, the Canadian CDMO BioVectra installed Heather Delage as its director of business development. She was named vice president of business development in 2014. In 2021, she assumed the role of chief commercial officer. At the outset of her tenure with BioVectra, the company was beginning its journey to invest in large-scale cGMP…
Why BioVectra has big mRNA biomanufacturing ambitions
Founded in 1970, BioVectra is a CDMO with specialties in microbial fermentation, complex chemistry and biologics. The company is looking to bolster its mRNA manufacturing capability. In November 2021, the Canadian company announced its intent to build a new $79.6 million facility dedicated to producing and manufacturing mRNA vaccines and therapeutics. The initiative resulted from…
Novartis refiles paperwork to FDA for novel cholesterol drug inclisiran
Novartis (NYSE: NVS) has resubmitted paperwork to the FDA for inclisiran, a subcutaneously-delivered drug candidate for treating hyperlipidemia in adults whose low-density lipoprotein cholesterol (LDL-C) remains elevated after taking a maximum tolerated dose of statin therapy. In Dec. 2020, FDA issued a complete response letter (CRL) for inclisiran. A CRL indicates that the agency has decided…
Answering the CDMO shortage: A new paradigm for drug development
What can the pharma industry do about the critical shortage of contract manufacturing organization (CMO) and contract development and manufacturing company (CDMO) facilities? For a growing number of young entrepreneurial drug companies, the answer is a middle ground between building their own facilities and outsourcing to the saturated CMO/CDMO market. This middle ground lies in…