Oral Solid Development and GMP Pilot-Scale Suite Enhancements Part of New Recipharm Investment
The company said this new commitment to its facility in Germany goes hand in hand with its recently announced ReciPredict, an initiative intended to streamline the product development cycle.
Science laboratory test tubes , laboratory equipment | Image Credit: © BillionPhotos.com - stock.adobe.com
Recipharm, a global contract development and manufacturing organization (CDMO) headquartered in Stockholm, Sweden, announced in a press release on Sept. 16, 2024 that it was making what the company called a “significant” investment in its Oral Solid Development and Pilot Scale Centre in Zwickau, Germany (1).
Among the main objectives of the investment are three new good manufacturing practice (GMP) pilot-scale suites for blending, tableting, and hard capsule filling, which Recipharm said will complement the facility’s existing GMP pilot-scale functions for both dry and wet granulation, and related tools for material science and characterization (1).
By making these upgrades, Recipharm said it hopes to position its Zwickau location as the “ideal partner” for such things as API and excipient characterization, clinical Phases II and III supply, lifecycle management, product and process development, product optimization, scale-up and tech transfers, and small-scale batch manufacturing (1).
The September 16 announcement comes less than two weeks after Recipharm introduced a platform for quality by design (QbD) called ReciPredict, which has three key goals, according to the company: providing an API consumption reduction of between 30% and 70% during development and scale-up, reducing the time to clinical stage by up to six months, and enabling a “fully integrated” approach to QbD (2).
ReciPredict, Recipharm said, will combine expertise in data science and statistics with robust statistical and modeling tools—the advanced statistical models, leveraged therein, connecting critical process parameters with material and drug product quality attributes (2). Both ReciPredict and the investments announced for the Zwickau facility are being positioned by Recipharm as efforts to streamline the product development cycle, from initial formulation to manufacturing, and increase the efficiency and reliability with which such products are able to be delivered to the pharmaceutical industry.
"With these advancements, we can now offer late-stage product development, clinical supply, and commercial manufacturing from a single site,” Uwe Hanenberg, PhD, Recipharm head of product implementation, said in the press release. “This integration makes it more efficient and cost-effective for our customers, providing them with access to top experts, while ensuring efficiencies in material consumption, including APIs. With our investment in ReciPredict as well as the GMP pilot scale for dry granulation and now the pilot scale for dry technologies, we have the tools and equipment at hand to support our custom with a faster clinic-to-market timeline for new drugs and de-risking manufacturing, ensuring greater certainty in meeting customer needs."
As far as a timeline for these improvements, Recipharm said the new pilot-scale center for dry technologies would be GMP-ready by the first quarter of 2025 (1).
The Zwickau branch is just one of Recipharm’s 21 locations worldwide, including two in the United States, in Boxborough and Watertown, both in Massachusetts.
References
1. Recipharm. Recipharm’s Investment Enhances Efficiency and Speed for Customers and Patients. Press Release. Sept. 16, 2024.
2. Recipharm. Introducing ReciPredict: Revolutionizing Drug Product Development and Manufacturing. Press Release. Sept. 4, 2024.
