From DCAT Week 2024: Supplier News: Chemicals/Chemical API Manufacturing
The latest news for CDMOs/CMOs and suppliers involved in the development and manufacturing of chemicals and chemical active pharmaceutical ingredients (APIs) with news from Olon, Grace, PharmaBlock, Axplora, ChemCon, Suven Pharma and The Solubility Company. Highlights below.
* Antheia, Olon Partner for API Mfg
* Grace Opens Expanded Fine Chemicals Mfg Facility
* PharmaBlock Opens HPAPI Mfg Facility
* Axplora Expanding ADC Mfg Capacity
* ChemCon Investing $7 M in Polymer Mfg Expansion
* Suven Pharma Investing $25 M To Increase Fine-Chemicals Mfg Capacity
* The Solubility Company Opens US Laboratory
Antheia, Olon Partner for API Mfg
Antheia, a pharmaceutical ingredient producer, and Olon Group, a Milan, Italy-based CDMO of active pharmaceutical ingredients (APIs) and intermediates, have announced an ongoing partnership to use Olon’s fermentation infrastructure to manufacture Antheia’s early products.
Antheia and Olon established a partnership in 2022 to use Olon’s fermentation sites across Italy. Olon has since played a role as a CDMO for scaling Antheia’s biomanufacturing processes and producing its biosynthetic key starting materials and APIs. Looking to 2024 and beyond, Antheia will continue to partner with Olon for additional capacity to meet demand for its first products, including thebaine.
Source: Olon
Grace Opens Expanded Fine Chemicals Mfg Facility
W. R. Grace & Co. (Grace), a fine and specialty chemicals company, has announced the opening of its expanded fine chemical contract development and manufacturing facility in South Haven, Michigan. With 25% more capacity, the expansion makes room for a new 4,000-gallon centrifuge and three 4,000-gallon, multi-use chemical reactors.
Source: Grace
PharmaBlock Opens HPAPI Mfg Facility
PharmaBlock Sciences, a CDMO of active pharmaceutical ingredients (APIs), has announced the opening of a new high-potency API (HPAPI) GMP facility at its Zhejiang, China, manufacturing site.
The new facility enables PharmaBlock to offer process R&D and kilo-scale production of HPAPIs and antibody-drug conjugate toxins. It spans an area of 1,000 square meters and is equipped with multifunctional rigid isolators and reactors ranging from 20 L to 100 L. The facility allows handling of potent compounds with occupational exposure limit (OEL) as low as 50 ng/m3 (OEB-5 and above). In addition to this new GMP HPAPI facility, multiple workshops at PharmaBlock Zhejiang are capable to manufacture OEB-4 compounds.
Source: PharmaBlock
Axplora Expanding ADC Mfg Capacity
Axplora, formerly Novasep-PharmaZell, a CDMO of small-molecule active pharmaceuticals ingredients (APIs), intermediates, and antibody drug conjugates (ADCs), is investing EUR 8 million ($9 million) to expand its facility in Le Mans, France, to add a new production suite of 200 square meters for antibody drug conjugate payload manufacturing. First production in the workshop is scheduled in the fourth quarter 2024.
Source: Axplora
ChemCon Investing $7 M in Polymer Mfg Expansion
ChemCon, a Freiburg, Germany-based CDMO of custom chemicals, active pharmaceutical ingredients (APIs) and analytical services, is investing EUR-6 million ($7-million) to expand its production facility with a new cleanroom to meet demand for GMP polymers and inorganics.
The investment is in addition to EUR 10 million ($11 million) already employed for developing and modernizing its facilities over the past few years. The company noted increased demand for polymers, especially polyethylenimines (PEI) and polyoxazolines (POx), in the pharmaceutical market. The new cleanroom was slated to start production in March 2024.
Source: ChemCon
Suven Pharma Investing $25 M To Increase Fine-Chemicals Mfg Capacity
Suven Pharma, a Hyderabad, India-based CDMO, has invested $25 million to expand its production facility in fine chemicals. The upgraded facility will have a total capacity of 665 KL, marking a 2.5 times increase from its current capacity of approximately 250 KL. The expansion equips the company to undertake large-scale manufacturing of raw materials-intermediates. The facility will feature 50 reactors, ranging from 3 KL to 16 KL working volume, comprising 19 stainless-steel reactors and 31 glass-lined reactors.
The investment will facilitate the development of pharmaceutical products at its Suryapet facility in India. The expansion project is scheduled to commence operations in June 2024.
Also, Suven Pharma is investing an additional $6.25 million for a new R&D center at Genome Valley, Hyderabad, India. Operations at the center are slated to commence in April 2024.
Source: Suven Pharma
The Solubility Company Opens US Laboratory
The Solubility Company, a CRO specializing in physicochemical measurement, has established a Single Particle Analysis (SPA) laboratory in Quakertown, Pennsylvania. SPA is the company’s proprietary technology used to measure solubility, dissolution rate, intrinsic dissolution rate, and pKa values for active pharmaceutical ingredients (APIs) with minimal material consumption (less than 100 µg per measurement). The SPA laboratory uses artificial intelligence and machine vision for enhanced drug solubility and dissolution rate analysis from microscopic samples.
The new laboratory initiated commercial operations in January 2024 after being commissioned in the fourth quarter of 2023. This move also broadens the company’s capabilities by adding further solid-state analytical services and integrating its SPA measurements with the particle-engineering services of its partner, Microsize, to streamline drug-development processes and improve bioavailability optimization from early-development phases.
Source: The Solubility Company