Contract Manufacturing, Drug Substance, API

The deal is worth up to $36 million with an initial upfront consideration of $14 million, with an additional $22 million in contingent value rights (CVRs) that is payable upon achieving certain milestones.

Detection of nitrosamines in several commercial drugs has resulted in manufacturing batch recalls followed by a review of the APIs’ synthesis processes by MAHs.

What factors do CDMOs consider vital to their success?

Actylis new 30,000-ft² API manufacturing facility is located in Eugene, Ore.

Snapdragon Chemistry concentrates in API batch and continuous flow process development, utilizing state-of-the-art automation technology and proprietary equipment to solve complex process and analytical development challenges.

Agilent’s $725 million investment is designed to double its capacity to produce APIs.

Vibha Jawa, executive director at Bristol Myers Squibb, and Luke Schenck, principal scientist at Merck & Com, discuss cell & gene therapies and co-processed APIs respectively.

Following the acquisition by Altaris Capital Partners, Johnson Matthey Health has rebranded as Veranova.

Lonza and Israel Biotech Fund form a two-year agreement to support accelerated development and manufacture of biologics and small molecules.

Piramal Pharma Solutions plans to construct a multipurpose ADC manufacturing and aseptic fill/finish facility in Grangemouth, Scotland, and to upgrades its existing API manufacturing facility in Morpeth, England.

China-based CDMO Asymchem acquires US-based chemical technology company Snapdragon.

Industry experts share their top outsourcing tips from both the perspective of companies offering outsourcing services as well as for companies looking to outsource.

Lonza has signed a five-year services agreement to provide for the development and manufacturing of biologics and small molecules for portfolio companies owned by Bioqube Ventures.

Samsung Biologics, GreenLight Biosciences, and Environmental Impact Acquisition Corp. have partnered to advance GreenLight’s mRNA COVID-19 vaccine candidate.

Hovione will invest $170 million in new capacity and capabilities in Portugal, Ireland, and New Jersey

Navigating a complex global regulatory landscape involves upfront research into the expectations of the different regulatory bodies, thorough documentation of every step of the API manufacturing process, and good communication.

Between dosage form versatility, product stability, lack of storage restrictions or need to refrigerate, and an easier means of purification, small-molecule APIs present an appealing market niche.

Quotient Sciences is investing £6.3 million ($8.68 million) into their drug substance manufacturing capabilities.

Curia plans to expand the site’s commercial capabilities with this move.

Biotage’s new facility in Cardiff, UK, will produce lipids using large-scale flash purification.

Almac Sciences has signed a manufacturing agreement with Pila Pharma for the production of the API XEN-D0501.

UltraBurst has a high disintegration speed, which is for all market segments, from prescriptions to nutraceuticals.

Purisys is now certified for ISO 17025 for testing and calibration laboratories and ISO 17034 for reference material producers

Centrient started production at its new statins API manufacturing unit in Toansa, India.

Through the acquisition, Aceto can now offer its customers support throughout the drug development process and access to North American manufacturing for APIs and advanced intermediates.

The companies are expanding their collaboration to extend the drug substance manufacturing of Moderna’s COVID-19 vaccine with the addition of a new manufacturing line at Lonza’s Geleen, Netherlands, site.

Expected to be completed by 2022, the new addition is part of the Samsung Biologics’ long-term strategy to become a fully integrated global biopharmaceutical company.

Colorcon’s new suite will provide clients with capabilities to develop prototype tablets or capsule dosage forms when API quantity is limited or the API potency requires a higher level of protection.

Moderna’s investments will double the formulation fill/finish and drug substance manufacturing of its vaccine to up to three billion doses in 2022 at various manufacturing sites.

Catalent’s new mammalian cell culture suites in Madison, Wis. use single-use bioreactor systems for CGMP clinical and commercial manufacturing.