As Curia expands, it will add API site in upstate New York; In battle against food allergies, Alladapt to build site to prep for PhIII trials
In July, contract manufacturer AMRI rebranded as Curia, and wrangled two biotechs to aid in its move toward global expansion. Thursday, the company announced that it will up its commercial manufacturing at its Rensselaer, NY site.
Curia will invest more than $35 million to double the batch-size scaling and packaging operations, and allow Curia to manufacture APIs for new products.
“Our Rensselaer team’s history of excellence in delivering U.S.-based complex manufacturing solutions that enable our customers to provide vital treatments to patients is resulting in increasing demand,” CEO John Ratliff said in a press release. “Some of the life-saving products produced at Rensselaer are highly complex, including critical oncology therapeutics and novel treatments addressing unmet medical needs. The engineering and technology advances we have designed for the site will enhance our flexibility, efficiency and scale, allowing us to meet our customers’ current and future complex manufacturing needs.”
The expansion will be done within the next 18 months, the company said. Currently, there are API manufacturing sites in France, Spain, India and Italy, in addition to the US.
In battle against food allergies, Alladapt to build site to prep for PhIII trials
Alladapt Immunotherapeutics will build a new manufacturing site to develop its lead candidate, focused on treating IgE-mediated food allergy.
The site will be 53,000 square feet and is located near Philadelphia, where the company’s CMO is located.
The goal is to eventually get full-scale production capacity for Phase III trials of ADP101. The candidate is designed to address the allergies to foods connected with 90% of all food allergies. Right now, the drug is in Phase I/II trials.
“One of the great strengths of Alladapt is our technical operations team, which has spent years addressing the specialized, novel challenges associated with producing pharmaceutical-grade single-and multi-allergen oral immunotherapeutic agents,” CTO Mike Holfinger said in a press release.
Food allergies to peanuts, tree nuts, fish and shellfish are associated with fatal and near-fatal food-induced anaphylaxis, and as of now, the best way to treat the allergy is avoidance of the foods, Alladapt said.
Expanded capacity coming to Rentschler’s Massachusetts manufacturing site
Six months after announcing the addition of a UK cell and gene therapy manufacturing site, German CDMO Rentschler Biopharma will expand its Boston production site in Milford, MA for two new bioreactors and more cleanroom space.
The new cleanrooms will add 22,000 square feet of space, and two 2,000 L single-use bioreactors will cut the complexity of manufacturing, the company said in a release. The site is expected to be up and running by late 2023.
With the plan comes an expansion of quality control, development and a warehouse. In a press release, CEO Martin Kessler said:
This is a very timely step, as the biopharma CDMO market is expected to grow by double digits over the next years, and RBMC US will play a pivotal role in our plans to continually outperform the overall market development. This new site will double our commercial cGMP manufacturing capacity. By bringing in state-of-the-art technology and industry 4.0 solutions, RBMC US will strongly enhance our value proposition in commercial manufacturing.
So far, the Milford site has expanded from a single-product facility to one producing several products with a 500 L bioreactor setup.
To aid in mRNA bottleneck, Biotage opens site in UK
In an effort to up its mRNA production and offer off-the-shelf lipids to use in vaccine production, Biotage will triple its production capacity by adding a new site in Cardiff, UK.
The move will help battle the raw material bottleneck that’s been caused by the ramp-up in vaccine production that’s come from the Covid-19 pandemic. The new site is operational as of Monday.
“Our customers needed to manufacture their products on a significantly larger scale, and we were able to invest in an expansion of our existing production facilities to support their requirements. We were very pleased to be able to deliver this expansion in just over four months in order to meet the needs of present and potential new clients,” EVP Anders Wikström said in a statement.