From DCAT Week 2023: Supplier News: Chemicals/Chemical API ManufacturingBy
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 PharmaBlock, Seqens, Polpharma API, Cambrex, Actylis, Avantor, Univar Solutions, Procos, Maithri Drugs, Dr. Reddy’s Laboratories, Jubilant Biosys, C2 Pharma, and ChemCon. Highlights below.
* PharmaBlock Investing $90 M To Expand API Mfg
* Seqens Opens New R&D Center in US; Investing $28 M To Expand HPAPI Mfg
* Polpharma API Investing $26 M for New HPAPI Mfg Facility
* Cambrex Expanding Small-Scale Commercial API Mfg & Flow Chemistry Capabilities
* Actylis Opens New API Mfg Site in Oregon
* Avantor Opens New Mfg and Distribution Center in Singapore
* Univar Solutions in Pact for Supply of Ibuprofen in Brazil
* Procos Investing $19 M To Expand HPAPI Mfg
* Maithri Drugs Investing $15 M To Expand API Mfg
* Dr. Reddy’s Laboratories Investing $12 M To Increase Flow-Chemistry Capacity
* Jubilant Biosys Expanding API Center of Excellence
* C2 Pharma Expands API Portfolio and GDP Logistics Services
* ChemCon Adding Inorganic Salts to Product Portfolio
PharmaBlock Investing $90 M To Expand API Mfg
PharmaBlock, a CDMO of active pharmaceutical ingredients and intermediates, is investing $90 million to expand its drug-substance manufacturing facility in Zhejiang, China. The facility added two new GMP workshops, including a continuous manufacturing area in 2022, and another GMP workshop is expected to open in the second quarter of 2023 to increase total capacity at the site to 635 cubic meters.
In addition, PharmaBlock USA opened a new campus in West Chester, Pennsylvania, in March 2023. This $13-million investment enhances PharmaBlock’s capabilities in developing and supplying clinical-stage APIs in the US.
Seqens Opens New R&D Center in US; Investing $28 M To Expand HPAPI Mfg
Seqens has opened the Seqens Boston R&D Center, a 15,000-square-foot Center of Excellence in Devens, Massachusetts. The facility, built with a $5-million investment, is designed to expand project flow, enhance quality, and accelerates development of active pharmaceutical ingredients (APIs) and excipients, including lipids used for the manufacture of RNA vaccines for COVID.
In addition, work is underway at the company’s site in Aramon, France, to build a new multi-tonnage production line for high-potency APIs (HPAPIs). The EUR-26 million ($28-million) investment will allow this new unit to deliver 10 T/year of HPAPIs, notably for anti-cancer and anti-virals treatments. Completion is scheduled for the end of 2023.
In addition, to combat a shortage of the pain reliever paracetamol, known as acetaminophen in the US, Seqens is currently building a plant in France to produce over half of Europe’s paracetamol needs.
Polpharma API Investing $26 M for New HPAPI Mfg Facility
Polpharma API, an EU-based CDMO and supplier of active pharmaceutical ingredients (APIs), is investing EUR 24 million ($26 million) in a specialized facility for R&D and production of highly active substances with an occupational exposure limit value down to 10 ng/m3 (OEB 6).
Construction of the new manufacturing building includes a separate process development laboratory, an analytical development laboratory with quality-control analysis capabilities, and a GMP kilo-lab-scale production line of max batch size up to 1.5 kg, with further expansion potential to double capacity. A high-potency API kilo-lab will have three reactors ranging from 5 L to 35 L. In the coming months, the facility will be dedicated for the fitting and installation of the equipment. The design of the plant has isolator technology to be used for personnel and product safety. The unit will become operative in the third quarter of 2024.
Source: Polpharma API
Cambrex Expanding Small-Scale Commercial API Mfg & Flow Chemistry Capabilities
Cambrex, a CDMO of drug substances and drug products, is making several investments to increase its capabilities in active pharmaceutical ingredient (API) development and manufacturing. Most recently, Cambrex acquired Snapdragon Chemistry, a Waltham, Massachusetts-based provider of flow chemistry and process development services. The acquisition adds to Cambrex’s expertise in continuous-flow process development and complements its existing continuous-flow capabilities at its facilities in High Point, North Carolina.
Cambrex is also expected to complete several expansions in 2023. Small-scale commercial manufacturing capabilities will come on line in High Point, North Carolina, by the end of 2023, which will double the facility’s capacity with new clinical and commercial manufacturing suites, and reactors up to 2,000 liters. In Europe, Q1 Scientific, a Cambrex company, will open a new 20,000-square-foot cGMP stability storage facility in Belgium.
Actylis Opens New API Mfg Site in Oregon
Actylis (formerly Aceto), a manufacturer and distributor, has opened a purpose-built 30,000-square foot-facility in Eugene, Oregon, for the development and manufacture of GMP-grade active pharmaceutical ingredients (APIs) and pharma intermediates. The site has seven manufacturing suites, and all cleanrooms will be ISO Class 8-compliant by the third quarter of 2023. A number of different reactors allow flexibility for a variety of chemistries.
The Eugene facility is the latest GMP manufacturing facility that Actylis has commissioned, along with other GMP sites in Montreal (Canada), Limerick (Ireland) and Ahmedabad (India), and is now part of a network of manufacturing facilities producing a range of pharmaceutical and biopharmaceutical products and customized high-purity lab chemicals.
Avantor Opens New Mfg and Distribution Center in Singapore
Avantor, a distributor and supplier of products and services to the bio/pharmaceutical industry, has established a new manufacturing and distribution hub in Singapore, integrating its existing distribution facility with new manufacturing operations. Avantor’s expanded offerings provide customers with assurance of supply with local manufacturing and distribution capabilities. With construction complete and the first batch having been produced in late 2022, the site will be fully operational in 2023. Avantor’s expanded cGMP manufacturing and ISO 9001 distribution hub exceeds 100,000 square feet.
The new hub is part of a continuing investment by Avantor in cGMP manufacturing and distribution capabilities globally, which also include the opening of a new distribution center in Dublin, Ireland, in the fourth quarter of 2022. The nearly 69,000-square-foot facility is Avantor’s second facility in Ireland, adding to its previous footprint of 76,000 square feet.
Univar Solutions in Pact for Supply of Ibuprofen in Brazil
Univar Solutions, a provider of specialty ingredients and chemicals, recently announced a distribution agreement with SI Group in Brazil for the active pharmaceutical ingredient, ibuprofen. The strategic partnership supports market growth in Brazil and is strengthened by Univar’s Solution Center in São Paulo.
Source: Univar Solutions
Procos Investing $19 M To Expand HPAPI Mfg
Procos, a Cameri, Italy-based CDMO of active pharmaceutical ingredients (APIs), is investing EUR 17 million ($19 million) to expand its existing high-potency API (HPAPI) manufacturing facility by adding two new cGMP small-scale and milling units. After several successful years of involvement in the HPAPI business, which started in 2018, the company decided to invest an additional EUR 17 million ($19 million) to create more capacity for the containment level with an occupational exposure limit of 10ng/m3 and to add new technologies in this area, such as chromatographic purification, nanofiltration systems, and freeze dryers.
Maithri Drugs Investing $15 M To Expand API Mfg
Maithri Drugs, a bulk drug manufacturing business based in Hyderabad, India, is investing $15 million to add new production blocks for active pharmaceutical ingredient (API) development and manufacturing at its facility in Bonthapally Village, Hyderabad, India. The expansion began in the second quarter of 2022 and is expected to be completed by the third quarter of 2023.
After the proposed expansion, the total capacity of 350KL (3x increase from its current 105KL) will enable the company to produce large-scale commercialized APIs. The company is also investing in an advanced microbiology lab facility that complies with all international standards.
Maithri Drugs has been manufacturing APIs in its cGMP facility since 2013. It has a dedicated facility and quality control labs with advanced analytical equipment.
Source: Maithri Drugs
Dr. Reddy’s Laboratories Investing $12 M To Increase Flow-Chemistry Capacity
Dr. Reddy’s Laboratories, a Hyderabad, India-based bio/pharmaceutical company and CDMO of drug substances and drug products, is investing to replace a batch manufacturing process with flow/continuous manufacturing from an intermediate to the active pharmaceutical ingredient (API), encompassing multiple reactions and unit operations. The $12-million investment is expected to result in an annual capacity of 100 metric tons for a key API.
Source: Dr. Reddy’s Laboratories
Jubilant Biosys Expanding API Center of Excellence
Jubilant Biosys, a contract research, development and manufacturing organization, is expanding its Chemistry Innovation Research Center (CIRC) in Greater Noida, India with the commissioning of 24,000 square feet of laboratory space dedicated to active pharmaceutical ingredient (API) development and manufacturing.
Opened in 2021, the CIRC is the company’s Center of Excellence for all drug-discovery related chemistry and currently accommodates over 1,000 full-time equivalents in the 120,000-square-foot facility.
Completion of the expansion in the second quarter of 2023 will deliver a single-site facility for the integration of discovery chemistry, process research and development, ADME (absorption, distribution, metabolism and excretion) support, analytical support, safety and hazard assessment, and kilo-lab and mini-plant drug-substance manufacturing from milligrams to the 20-kg scale, including high-potency APIs to an occupational exposure limit (OEL) of Band 4.
Source: Jubilant Biosys
C2 Pharma Expands API Portfolio and GDP Logistics Services
C2 Pharma, a manufacturer of active pharmaceutical ingredients (APIs), is advancing several key expansions in 2023. The company is moving its headquarters to Cork, Ireland and will begin operations with its India affiliate. In parallel, the company plans an expansion in its ophthalmic API portfolio. Following the introduction of tropicamide, brimonidine, latanaprost, and bimatoprost in 2022, the company is adding oxybuprocaine and brinzolamide in 2023. Its R&D development affiliate, ASM Research Chemicals, is expanding its API development service offering with standardized R&D packs, “DevPack,” for new API development. Meanwhile in Frankfurt, Germany, through Logistics4Pharma, a pharmaceutical cold-chain packaging, storage, warehousing, and logistics specialist, the company secured a new GDP (Good Distribution Practice) customs-bonded and ISO warehouse space of 950 square meters equipped at all temperature ranges from -80 degrees Celsius to +25 degress Celsius.
Source: C2 Pharma
ChemCon Adding Inorganic Salts to Product Portfolio
ChemCon GmbH, a Freiburg, Germany-based CDMO of active pharmaceutical ingredients (APIs), is expanding its business model from classic small-molecule custom manufacturing and analysis to offer a new range of non-exclusive substances: inorganic salts for use in injection grade as full GMP APIs. Three drug master files (DMFs) for the commonly named “trace elements” have already been filed with the US Food and Drug Administration, and the company plans to file up to five new DMFs in 2023. Additionally, three DMFs are planned for 2024. ChemCon says it will add products to this class of substances in the next one to two years with an expected investment of at least EUR 5 million ($5.5 million) for development, scale-up, validation, registration, stability programs, special production, and analytical equipment as well as for the marketing of these projects.