Florida biotechnology CDMO adding commercial production

Goodwin Biotechnology will build a 40,000-square-foot facility to handle commercial-scale projects. (Goodwin Biotechnology)

After specializing for decades in the production of clinical supplies for biopharma clients, a Florida CDMO has decided it is time to move its services up a notch.

Goodwin Biotechnology said last week it will build a 40,000-square-foot facility next to its existing operations in Fort Lauderdale, doubling its space to take on bigger production projects. The company declined to say what it will invest in the expansion.

“Based on the success of biopharmaceutical candidates that we have helped successfully navigate through their early- and late-stage clinical trials, we have strategically aligned ourselves to invest in doubling our cGMP manufacturing capacity and enhancing our regulatory compliance to support commercial manufacturing,” CEO Karl Pinto said (PDF) in a statement.

Free Daily Newsletter

Like this story? Subscribe to FiercePharma!

Biopharma is a fast-growing world where big ideas come along daily. Our subscribers rely on FiercePharma as their must-read source for the latest news, analysis and data on drugs and the companies that make them. Sign up today to get pharma news and updates delivered to your inbox and read on the go.

The company has traditionally produced monoclonal antibodies, recombinant proteins, vaccines, and biologic drug conjugates including antibody drug conjugates for early- and late-stage clinical trials. But it has been adding capabilities so that it can move to commercial scale projects. Goodwin has already increased its process development capabilities, more than doubling its development bioreactor laboratory. It also has expanded its purification and bioconjugation development and other operations.

The move to commercial production scale comes as a large number of new drugs requires biopharma capabilities but often target small patient populations. The new facility will allow Goodwin to do small- to mid-volume commercial production runs, “which we increasingly see as the future of biopharmaceutical manufacturing,” Pinto said.

Suggested Articles

The FDA is allowing some drugmakers to exceed the level of risk from a probable cancer-causing impurity in losartan for six months.

The FDA hit United Exchange Corp. with a warning letter, citing the company for a number of “significant” violations with its quality control systems.

With a deal for the digoxin portfolio of Poland's Nobilus, C2 Pharma will have two supplies of API for making the sometimes difficult-to-get drug.…