Italian CDMO Olon Group has announces the ongoing construction of a high potency API (HPAPI) suite at the site in Concord, Ohio, which hosts its centre of excellence for early development of APIs. This adds to the commercial-scale capabilities of sites at Segrate and Rodano, near Milan, Italy, where Olon has invested about €40 million in the last few years.
Germany-based Evonik and Heraeus Precious Metals have announced that they are collaborating to expand their range of services for HPAPIs. They intend to build a fully integrated offering from the pre-clinical stage to commercial manufacturing, with streamlined transfer between small- and large-scale production between their respective sites.
Heraeus’s Pharmaceutical Ingredients business offers customised services for both earlier and later clinical phases and smaller to mid-volume HPAPI commercial products. It claims to be the world’s leading supplier of platinum-based HPAPIs.
In response to an increasing number of projects, notably in oncology, Indian CRDMO Sai Life Sciences, has opened a 1,485 m2 high potency API (HPAPI) facility at its cGMP API campus in Bidar. This follows on from the opening of an HPAPI development facility at the Hyderabad R&D campus.
The company said that this expands its expertise “across HPAPI development and manufacturing, providing its customers with a streamlined pathway for NCE development”. It will now be able to handle all aspects of the product life cycle.
Italian CDMO and API supplier Olon has presented a two-year, €30 million plan to expand its Settimo Torinese Biotech Hub near Turin. This focuses on microbial fermentation and is claimed to have “some of the most extensive know-how” on the subject in Europe”. The plan focuses on therapeutic peptides based on Olon’s expertise in the development of rDNA peptides and proteins.
Lonza has completed the expansion of a multi-purpose. kilogram-scale HPAPI manufacturing suite at its main site in Visp, Switzerland. This adds development and manufacturing capacity for ADC payloads, “supporting the entire development and manufacturing pipeline from feasibility studies to commercial supply”.
WuXi AppTec has announced a plan to build a new R&D and manufacturing site in Singapore at a cost of up to $1.4 billion. It will be created in stages over the next ten years, depending on the company’s business needs.
The company added that the site will serve “a critical role in its global network across Asia, Europe and North America”. It ill include “laboratories and facilities that provide a broad portfolio of R&D and manufacturing services” for the pharmaceutical industry.
Lonza has completed an expansion at its API manufacturing site at Nansha, China, as part of its recent investment to expand mid-scale capacity there. This focused on extending the capabilities and capacity of development laboratories and kilo-scale cGMP manufacturing laboratories for clinical supply of HPAPIs.
