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.