Phase 3 Expansion of Kalamazoo Facility

BY PAOLA CLERICI, COMMUNICATIONS MANAGER, DIPHARMA

Throughout its history, innovation has always been at Dipharma’s core.

The Dipharma Group is a global Contract Development and Manufacturing Organization (CDMO) and a leading manufacturer of Active Pharmaceutical Ingredients and Intermediates for generic and contract manufacturing markets.

As part of the global pharmaceutical industry, it serves human health and, therefore, operates to the highest standards of quality and safety with proven experience in handling complex and hazardous processes.

Dipharma was founded in 1949 some 100 km northeast of Venice, Italy, by Mario Biazzi, who created an innovative, and much safer, continuous process to manufacture nitroglycerin. It has expanded its global presence, with more than 500 skilled and highly committed employees, serving over 200 customers in more than 60 countries, including biotech, biopharma and leading pharmaceutical companies.

The company’s fully equipped R&D centers, in the U.S. and Italy, foster development of robust chemical synthesis, to further secure the manufacturing continuity of the Drug Substance in our 4 cGMP plants while manufacturing sites located in U.S. and Italy and are equipped to supply quantities suitable from preIND to market, covering the entire lifecycle of a drug.

Full compliance with the highest GMP quality standard has been confirmed, since 1970, by an extensive list of successful inspections conducted by major Regulatory Agencies, such as the FDA, Italian Health Authorities and PMDA.

Nowadays the Dipharma Group is a third-generation family-owned company with an outstanding history of stability and financial soundness, and a strong commitment to integrating the principles of Corporate Social Responsibility into its business and all its corporate activities.

Dipharma established its presence in the US market in 2012, with the opening of a new office, Dipharma Inc., and, 6 years later, further reinforced it with the acquisition of the Kalamazoo-based Kalexsyn, Inc., a world-class Contract Research Organization (CRO) founded in 2003. This purchase represented a complement to Dipharma’s existing business and in accordance with its strategic decision to strengthen its position in the CDMO market and leverage its presence in the United States, in 2020 Dipharma inserted the missing tile of the puzzle with the completion of a brandnew cGMP suite in Kalamazoo site, that will mostly provide clinical supplies across Phase 1 and early Phase 2. This enhanced the role of the Kalamazoo site from CRO to CDMO and therefore enabled the Dipharma Group to cover the whole lifecycle of a molecule, from discovery to commercialization.

The state-of-the-art QC laboratory is designed and equipped according to current pharmaceutical quality standards, with full 21CFR Part 11 Electronic Data Integrity compliance including automated monitoring of environmental systems.

The Company recently completed the second phase of its expansion of the Kalamazoo facility. The additional 2000 ft2 of space has been designed to complement the cGMP Kilolab and quality control laboratories, and to support further expansion of the site. This new space triples the size of its cGMP quality control laboratory and significantly increases the warehouse spaces.

The state-of-the-art QC laboratory is designed and equipped according to current pharmaceutical quality standards, with full 21CFR Part 11 Electronic Data Integrity compliance including automated monitoring of environmental systems.

The new, larger warehouse spaces are fully-climate controlled and allow for greater material storage with increased material segregation.

Furthermore, the Kalamazoo-based R&D department is adding analytical method development services to its portfolio to aid in bringing pre-clinical projects into the clinical realm. This additional tool is completing the broad portfolio of services that Dipharma can provide to its customers, including development of chromatographic methods, expertise in solid-state properties, safety, elemental impurities, potentially genotoxic impurities, IP, and commercialization services.

Up next for the Kalamazoo facility is the installation of a larger second line of reactors for the cGMP Kilolab production suite. This third phase of the expansion will add two ca. 82 L reactors to the Kilolab, allowing the Kalamazoo group to better implement early-phase deliveries where processes may not yet be fully optimized for commercial delivery. This expansion is currently underway and is scheduled for completion in summer 2023.

This expansion mirrors investments the Dipharma Group is making in its Italian facilities, adding to R&D laboratories and doubling of pilot plant capacity, with the aim to further strengthen Dipharma’s capacity and support the growing demand for its contract development and manufacturing activities.

All these investments strengthen Dipharma’s offerings and allow the Group to offer a full range of contact services, ensuring continuity across the whole lifecycle of pharmaceutical development, from preclinical to commercial deliveries.