DCAT Week 2022: Supplier News Roundup: Chemicals & Chemical API Mfg

As part of the DCAT Member Company Announcement Forum, held on March 21, 2022, at DCAT Week, the flagship event of the Drug, Chemical & Associated Technologies Association (DCAT), DCAT invited its Member Companies to submit major news announcements from their companies of significance to the bio/pharmaceutical manufacturing value chain. The news could cover manufacturing expansions, mergers and acquisitions (M&A), including post-M&A integration, or other key corporate developments with the announcements or related news made in the announcement occurring in 2022 and beyond.

CEOs and senior executives from 12 DCAT Member Companies were selected to outline their news at the DCAT Member Company Announcement Forum on March 21, 2022. Given time limits in the two-hour program, all DCAT Member Companies were given the opportunity to share news as part of this special edition of DCAT Value Chain Insights that highlights news from DCAT Week. The news submitted from companies involved in the development and manufacturing of chemicals and chemical active pharmaceutical ingredients (APIs) are outlined below.

  • Flamma To Acquire API Mfg Site from Teva
  • Novasep in $55 M API Expansion; Merges with PharmaZell
  • Aceto Investing $25 M in Facility Expansions
  • Formosa Laboratories in $20-M Expansion for APIs, ADCs, Peptides
  • Olon Expanding HPAPI Mfg
  • Porton in New Facility for Drug-Substance and Drug-Product Development
  • Sai Life Sciences Investing in Multiple Expansions
  • Seqens Invests in R&D Labs
  • Cerbios-Pharma Provides Update on HPAPI Expansion
  • Procos Launches Automation System for API Development
  • ChemCon Adds Additional DMFs to its Portfolio

Flamma To Acquire API Mfg Site from Teva
Flamma Group, a CDMO of small-molecule active pharmaceutical ingredients (APIs) and intermediates, has announced that it will acquire a third API manufacturing site in Italy as of April 2022.

Flamma reached an agreement earlier this year (2022) with Teva Group for acquiring the Sicor Bulciago site located in Lecco, Italy, 30 kilometers from Flamma’s headquarters. The GMP facility has more than 600 cubic meters of manufacturing capacity and has been previously inspected by the FDA, the Italian Ministry of Health (AIFA), the Brazilian Health Regulatory Agency (ANVISA) and has been accredited by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).

With the Bulciago site, Flamma adds 600 cubic meters of manufacturing capacity to bring its total capacity in Italy to over 900 cubic meters. This goes along with the soon-to-be 600 cubic meters of manufacturing capacity in China as the company begins expansion of Flamma Honkai this year (2022).

This is the latest in a series of investments for the company, which over the past several years has included the addition of Flamma USA in Malvern, Pennsylvania, just outside Philadelphia, to handle early-stage small-molecule projects. The soon-to-be completed R&D expansion at the company’s site in Chignolo, Italy, will quadruple its R&D space there and allow for more R&D capabilities and additional analytical resources. Flamma says it will invest over EUR 150 million ($167 million) over the next three years for increasing capacity and adding new technologies across its sites in Italy, China, and the US.

Source: Flamma Group

Novasep in $55-M API Expansion; Merges with PharmaZell
Novasep, a Lyon, France-based CDMO of active pharmaceutical ingredients (APIs) and antibody drug conjugates, is investing a total of EUR 51 million ($55 million) at four of its European sites, located in France and in Germany, for active pharmaceutical ingredient (API) development and manufacturing services for pharmaceutical innovators.  These investments, which will be completed in 2022 and 2023, include the modernization and addition of new API manufacturing workshops, the extension of clinical and commercial high-potency API capabilities, including antibody drug conjugates payloads and the addition of cGMP pilot-scale flow-chemistry capability.

This week (April 7, 2022), Novasep and PharmaZell, a Raubling, Germany-based CDMO of small-molecule APIs, closed their merger of the two companies. The companies had entered exclusive negotiations in September 2021. The combined company has a footprint in Europe, the US, and India with combined revenues of nearly EUR 500 million ($545 million) and more than 2,000 employees across 10 production and R&D sites: seven in Europe, two in India, and one in the US.

Source: Novasep

Aceto Investing $25 M in Facility Expansions
Aceto, a provider of specialty materials for life sciences and advanced technology end markets, is investing $25 million to expand three of its North American facilities in 2022. The facilities are from three companies that Aceto acquired in 2020/2021: Cascade Chemistry, a CDMO of regulatory starting materials, intermediates, and active pharmaceutical ingredients (APIs); Islechem, a provider of contract research and development, analytical services, and technical support services; and A&C, a manufacturer of specialty excipients, buffers, and process solutions.

The most significant expansion is a large-scale cGMP expansion at its Cascade Chemistry by Aceto facility in Eugene, Oregon. The site currently performs development and scale-up of small-molecule APIs through Phase II, and the expansion will support projects to Phase III and potentially commercialization. The company is also doubling R&D capacity at its Oregon facility. The expansions are expected to completed in the third quarter 2022.

Aceto is also investing in its Islechem facility in Grand Island, New York, by expanding production capacity and refurbishing 10,000 square feet of laboratory space. The company also has begun construction of a GMP liquid manufacturing expansion at its A&C by Aceto facility in Montreal to create redundant water-for-injection capacity in North America, which will enable a rollout of its GMP buffer offering to its North American customer base.

In addition to Cascade Chemistry, Islechem, and A&C, Aceto made three other acquisitions in 2020/2021: (1) A&C Bio Buffer, a manufacturer of custom buffer and chemical blend products used in the manufacturing of biopharmaceutical drug products and vaccines; (2) Finar, a manufacturer, supplier, and distributor of pharmaceutical excipients, lab chemicals, aquaculture inputs, and food-grade additives; and (3) Syntor Fine Chemicals, a fine chemical manufacturer offering process development and R&D services. Also, earlier this year (2022), Aceto acquired Biotron Laboratories and Talus Mineral Company (affiliated entities collectively referred to as Biotron). Both companies are manufacturers of specialty ingredients for the nutritional supplements industry.

Formosa Laboratories in $20-M Expansion for APIs, ADCs, Peptides
Formosa Laboratories, a Taoyuan, Taiwan-based CDMO of active pharmaceutical ingredients (APIs), antibody drug conjugates (ADC) and injectables, is investing $20 million to expand its API manufacturing facility to build up its bioconjugation ADC platform, a peptide-generation system for personalized medicine production, and a microfluidic synthesis system at its current facility in Taiwan. The expansion is expected to broaden the services spectrum for peptide development and microfluidic synthesis as well as advance capacity for high-potency APIs and ADCs. The expansion began in January 2022 and is expected to be completed in 2023.

Source: Formosa Laboratories

Olon Expanding HPAPI Mfg
Olon is investing EUR 13 million ($14 million) to add a new production line for high-potency active pharmaceutical ingredient (HPAPI) manufacturing and to expand a large-scale HPAPI production line at its site in Rodano (Milan, Italy). Timeline for completion and start-up is 2023.

The investment will allow for a Safebridge 3B containment level corresponding to an occupational exposure limit (OEL) of OEL 0.03 μg/m3 for the new production line and an OEL of 1-0.1 μg/m3for the expanded large-scale line.

Olon is headquartered in Rodano (Milan, Italy) and has 11 manufacturing facilities: eight facilities in Italy, one in Spain, one in US and one in India.

Source: Olon Group

Porton in New Facility for Drug-Substance and Drug-Product Development
Porton Pharma Solutions, a CDMO, is creating a new R&D facility with a  more than $20-million investment in Cranbury, New Jersey, for its US-based R&D center, J-Star Research, Inc.. This facility adds approximately 43,000 square feet of R&D and cGMP labs and suites for integrated drug-substance and drug-product R&D services and Phase I supplies. It will co-house the Center for Pharma Crystallization, Drug Product Development, and cGMP Drug Product Manufacturing, with operations beginning in the third quarter of 2022. An additional 90,000 square feet in the same building is reserved in anticipation of growth. Four discrete cGMP suites will allow implementation of enabling technologies (e.g., kg-scale spray drying, drug substance–drug product co-processing, intensified processing) aside from typical formulation approaches for producing oral solid dosage forms.

Source: Portun Pharma Solutions

Sai Life Sciences Investing in Multiple Expansions
Sai Life Sciences, a CRO and CDMO, has made a series of investment to expand high-potency active pharmaceutical ingredient (HPAPI manufacturing, amidites manufacturing and an R&D facility in the UK. 

Work is underway to set up a dedicated facility for HPAPIs at the company’s manufacturing campus in India. This facility follows the company’s recent opening of a new HPAPI development facility at its R&D campus in Hyderabad, India. Being built with a project outlay of $3.6 Million, the HPAPI manufacturing facility will have six reactors ranging from 100 L to 1000 L of various materials of construction (stainless steel/ Hastelloy/glass-lined). The 15,000-square-foot facility is expected to be ready in the second quarter of 2022.

Sai Life Sciences is also investing $2 million for a new 15,000-square-foot dedicated amidites manufacturing facility. The facility will be equipped with reactors ranging from 500 L to 1600 L of various materials of construction (stainless steel/ Hastelloy/glass-lined) and is scheduled for completion in the second quarter of 2022.

In addition, the company has scaled up its R&D facility in the UK. This includes a new chemistry and analytical lab at Alderley Park, Manchester, a four-fold increase in floor space from 5,000 to 20,000 square feet, an increase in fume cupboards from 24 to 80, and onboarding of more scientists from 23 to 60. Other capabilities added over the last 12 months were Integrity 10 parallel screening tool, Open Access GCMS, Open Access Chiral HPLC, Open Access 400 MHz NMR, physical properties analytical equipment (DSC/TGA, XRPD, PSD) and LCMS with accurate mass. The projects, entailing an investment of $3.8 Million, were completed in February 2022.

Seqens Invests in R&D Labs
Seqens has announced a multi-million-dollar investment in its research and development laboratory in Devens, Massachusetts, to enhance its capabilities in the development and production of active pharmaceutical ingredients (APIs) and active delivery systems (lipids and polymers) development. Completion of the project is expected beginning 2023.

The investment comes three months after SK Capital became a majority holder in Seqens by merging it with SK Capital’s portfolio company, Wavelength Pharmaceuticals, a Petah Tikvah, Israel-based CDMO of APIs.

Source: Seqens

Cerbios-Pharma Provides Update on HPAPI Expansion
Cerbios-Pharma, a Swiss-based CDMO of chemical and biotechnological active pharmaceutical ingredients (APIs), is nearing finalization of the structure for its new manufacturing building dedicated to high-potency APIs (HPAPIs), which will host two additional cGMP production lines for cytotoxic molecules and additional space for dedicated R&D and quality control labs.

The construction of the new building is almost complete, and the next 10-12 months will be dedicated for the fitting and installation of the equipment. The new cGMP unit (SafeBridge Category 4) will become operative in the second quarter of 2023 and will host production ranging from 200 mg to 2 kg per batch.

Cerbios has been active in the HPAPI arena since 1993, handling up to SafeBridge Category 4 (occupational exposure limits < 10 ng/m3) drug substances. It has dedicated R&D and scale-up facilities and cGMP manufacturing lines ranging from grams up to 30+ kg-batch size. The company manufactures both cytotoxic and non-cytotoxic HPAPIs.

Procos Launches Automation System for API Development
Procos SpA, a Cameri, Italy-based CDMO of active pharmaceutical ingredients (APIs), has launched the CHEMSPEED automation system as tool for its research and development to support new drug application customer projects. The launch follows an investment of EUR 1 million ($1.08 million) for the first installation of six reactors during 2021, with the balance of six reactors to be implemented by April 2022.  The company says that the technology will further enhance the timeline for API development and submission to regulatory authorities and sponsors’ timelines.

ChemCon Adds Additional DMFs to its Portfolio
ChemCon, a Freiburg, Germany-based CDMO, recently registered drug master files (DMFs) for Copper (II) chloride and zinc chloride. The company already owns two active DMFs for arsenic trioxide and sodium nitroprusside to extend its catalogue for the US market. Sodium selenite, chromium (III) chloride, sodium molybdate (VI), iron (III) chloride, manganese (II) chloride, and methylene blue DMFs are expected to follow in 2022. Through organizational changes and enlargement of existing building capacities to 6,000 m2, ChemCon is now able to produce some 20 commercial active pharmaceutical ingredients to build up a new business model alongside the contract manufacturing and analytical services it already provides.