FOR IMMEDIATE RELEASE

ACS News Service Weekly PressPac: June 30, 2021

Small biotechs team up with big partners to manufacture drugs

“Biotech firms on the shoulders of giants”
Chemical & Engineering News

Many of the most promising new molecules to treat diseases come from smaller biotechnology firms, which often lack resources to scale up production when it’s time for their drugs to go to large-scale clinical trials or the market. Now, a cover story in Chemical & Engineering News (C&EN), the weekly newsmagazine of the American Chemical Society, describes how small biotechs are teaming up with big pharmaceutical outsourcing firms to manufacture their molecules.

Small biotech companies often excel at innovation and are quick to make decisions, allowing them to rapidly move new drugs from the conceptual stage to clinical trials. If the drugs show promise in early trials, these companies are faced with the daunting task of scaling up production to support large-scale phase 3 trials, write C&EN staff. And if the molecule receives approval from the U.S. Food and Drug Administration (FDA), multiple metric tons could be needed each year. So many biotechs are seeking large, experienced manufacturing partners to help bring lifesaving drugs to the patients who need them. 

The small firm Mithra Pharmaceuticals recently received FDA approval for Estelle, a contraceptive drug containing a natural estrogen with potentially fewer side effects than current products. Mithra partnered with French firm Seqens to produce the compound, with a complex synthetic process that took 4 years to develop at an industrial scale. Recognizing the potential of the new estrogen, Seqens recently spent $35 million on a brand-new facility dedicated to its production. Similarly, Aurinia Pharmaceuticals will use a dedicated plant built by large contract manufacturer Lonza to produce a new drug that received FDA approval earlier this year for lupus nephritis, a dangerous kidney condition. And the tiny biotech Cassava Sciences has teamed up with the giant Evonik Industries to make an experimental Alzheimer’s treatment for phase 3 clinical trials and, possibly, later commercialization.

The American Chemical Society (ACS) is a nonprofit organization chartered by the U.S. Congress. ACS’ mission is to advance the broader chemistry enterprise and its practitioners for the benefit of Earth and all its people. The Society is a global leader in promoting excellence in science education and providing access to chemistry-related information and research through its multiple research solutions, peer-reviewed journals, scientific conferences, eBooks and weekly news periodical Chemical & Engineering News. ACS journals are among the most cited, most trusted and most read within the scientific literature; however, ACS itself does not conduct chemical research. As a leader in scientific information solutions, its CAS division partners with global innovators to accelerate breakthroughs by curating, connecting and analyzing the world’s scientific knowledge. ACS’ main offices are in Washington, D.C., and Columbus, Ohio.

To automatically receive press releases from the American Chemical Society, contact newsroom@acs.org.

###

Note: ACS does not conduct research, but publishes and publicizes peer-reviewed scientific studies.

cen