Driven by demand for an increasing complexity and diversity of modalities, CDMO Rentschler has broken ground on a second facility in Milford, Massachusetts.

German contract development and manufacturing organization (CDMO) Rentschler laid down its US roots in 2019 when it bought a biomanufacturing facility from the now defunct Shire in January 2019 in Milford, Massachusetts – about 20 miles southwest of Boston.

Now the firm has begun expanding its presence, breaking ground on facility adjacent to the ex-Shire plant set to add 22,000 square feet of manufacturing cleanroom space to the CDMO’s offering once operational in 2023.

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“The expansion will double Rentschler Biopharma’s commercial cGMP capacity,” Rentschler’s Cora Kaiser, senior director Corporate Communication told BioProcess Insider. “We currently have a variety of bioreactors, ranging from 500 L to 3,000L in size; with the new facility to house four 2,000L single-use bioreactors, this is an important and significant expansion for us.”

The expansion – financials of which have not been divulged – has been driven by demand for a multitude of therapeutic modalities, according to Kaiser.

“With Rentschler Biopharma’s contribution to the production of mRNA vaccines to beat the COVID-19 virus, we have seen firsthand how important it is to have highly adaptable capacity and to have the experience and expertise needed to produce new therapeutic modalities, fast,” she said.

“This US expansion is part of our ongoing plan to strategically grow our business as we support our clients in developing and manufacturing even highly complex molecules.”

Expanded modalities, expanded presence

Since the pandemic, Rentschler has been involved with various COVID-19 programs, including Pfizer/BioNTech’s commercial vaccine and CureVac’s currently stalled vaccine program.

“COVID-19 has certainly shown the world how important biopharma manufacturing is to bringing new and effective treatments and vaccines to patients. What we have also seen is an increasing complexity and diversity of therapeutic modalities, as well as more companies focusing on developing effective treatments for rare diseases,” Kaiser continued.

“These developments are truly exciting, particularly for doctors and their patients and families. But they also have added production challenges with the need to produce a wide variety of high-quality, safe therapies that range from small molecules to antibodies to mRNA vaccines to cell and gene therapies and much, much more.  And, the required quantities vary widely, too, from therapies for ultra-rare diseases to hundreds of millions of vaccine doses.

“It is truly an exciting time to be in this field, and Rentschler Biopharma is not only meeting today’s challenges, but we are already thinking about what could come next. The new site is part of our strategy to address these ever-changing and growing needs of our clients.”

The Milford investment follows is the third expansion for Rentschler in the past 6 months.

In February, the CDMO set up manufacturing capabilities at the UK’s Cell and Gene Therapy (CGT) Catapult, launching itself into the regenerative medicine space. And in June, the firm began an expansion at its Laupheim, Germany facility to support the increasing demand for complex antibodies.