High-Potency Manufacturing a Strong Spot in CDMO/CMO Market

High-potency manufacturing continues to attract the investment dollars of CDMOs and CMOs. So what are the key projects?

Growth in the oncology market, including the niche area of antibody drug conjugates (ADC), is driving investment in high-potency manufacturing for drug substances and drug products. DCAT Value Chain Insights (VCI) rounds up the activity.

A roundup of activity 
Growth in the global oncology drug market is an important measure of opportunities in drug development and manufacturing, including for contract manufacturers of active pharmaceutical ingredients (APIs) and finished drug products. On the small-molecule side, whether as an API or finished drug product and depending on the product involved, growth in the oncology market is one indicator of potential opportunities in high-potency manufacturing. Within the oncology market, a niche market area are ADCs, which consist of a cytotoxic small molecule linked to a monoclonal antibody. ADCs, certain oncology drugs, and other high-potency compounds (such as hormones) require high-containment manufacturing, which involve specialized approaches in facility design, equipment selection, and manufacturing processes to achieve the desired levels of containment and minimize operator exposure. Several contract manufacturers have recently invested in high-potency manufacturing. Below is a roundup of activity as announced in 2015 and 2016 to date. 

ADC Biotechnology. In October 2015, UK-based ADC Biotechnology announced a $10 million plan to build a 1,500 square meter manufacturing facility in St Asaph, North Wales, UK, for advanced anti-cancer drugs. The two-stage expansion program marks the transition of ADC Biotechnology into GMP manufacturing of ADCs. Phase 1 of the project will come on stream in mid-2017, creating a 1,500 square meter dual-stream facility for process development, manufacturing, and quality testing of ADC drugs.The new facility will be able to produce clinical trial and low-volume commercial quantities. A projected second phase is planned to add another 2,500 square meters of manufacturing space for larger-scale clinical and commercial manufacturing.The company also added, a £100,000 ($155,000) R&D lab, focused on bio-conjugation and payload-linker chemistry in early 2015. 

Catalent. In January 2016, Catalent, through its wholly owned subsidiary, Redwood Bioscience, formed a research collaboration with Roche to develop molecules coupling different therapeutic modalities using Catalent’s proprietary SMARTag technology, an ADC platform. Under the deal, Roche gains non-exclusive access to the SMARTag platform and will have an option to take commercial licenses to develop molecules directed to a defined number of targets. Roche will pay Catalent an up-front fee of $1 million and provide additional research funding during the initial phase of the collaboration. Catalent has the potential to receive up to $618 million in development and commercial milestones, plus royalties on net sales of products, if Roche pursues commercial licenses and all options are exercised. Catalent announced in April 2013 that it had acquired an exclusive license to market the SMARTag technology and subsequently collaborated with Redwood for the ongoing development and marketing of the platform. It later acquired Redwood in 2014. The SMARTag technology enables the generation of homogenous bioconjugates, and is engineered to improve performance and manufacturing.

On the drug product side, in January 2015, Catalent Pharma Solutions expanded its potent handling and manufacturing capabilities at its facility in Somerset, New Jersey. The company completed the expansion of facility and engineering controls for its high-potency tableting and OptiMelt Hot Melt Extrusion operations in Somerset to supplement existing potent capabilities in oral solid and its Zydis Fast Dissolve manufacturing. The company invested in additional potent containment for large-scale blending, fluid-bed processing, and high-shear granulation. The expansion created a manufacturing Center of Excellence for potent handling across Catalent’s portfolio of oral solid manufacturing solutions, which includes hot-melt extrusion, high-shear and wet granulation processing, solvent-based capability, extrusion/spheronization, fluid-bed processing, Wurster coating, and compression and encapsulation. The company also invested in high-potency clinical packaging.

Cerbios-Pharma. Earlier this year, Cerbios-Pharma opened a new research and development (R&D) center for high-potency active pharmaceutical ingredients (HPAPIs) and monoclonal antibody (mAb) development. Cerbios is a privately held company located in Lugano, Switzerland, which specializes in the development and manufacture of both chemical and biological APIs. Exclusive, third-party manufacturing services are offered by the Chemical Division for HPAIs and by the Biological Division for mAbs, recombinant proteins, and pharma probiotics.

The construction of the investment was approved in November 2013 and started in April 2014. The new building consists of four floors of 280 square meters each. The second floor houses biological R&D, with three dedicated laboratories for the development of mAbs and/or recombinant proteins based on Chinese hamster ovary (CHO) mammalian cells and a large laboratory to develop pharmaceutical probiotics. The first floor houses a new additional GMP archive and offices for the directors and for the managers of R&D and quality assurance. The ground floor houses chemical R&D, doubling the capacity to develop HPAPIs for contract manufacturing services, including Safebridge Category 4 products. Underground floors house two warehouses (one for R&D and one for production) and personnel services.

CMC Biologics and IDT Biologika , CMC Biologics, a contract provider of clinical and commercial manufacturing of monoclonal antibodies and other therapeutic proteins, and IDT Biologika GmbH, a privately held life-science company with expertise in research, development and manufacture of biologics for human and animal health, formed a strategic collaboration earlier this year to provide a complete solution for the manufacture of ADCs. Within this collaboration, CMC Biologics will perform process development and manufacture of the bulk mAb, and IDT Biologika will perform services from conjugation of the cytotoxic drug to the antibody substance through to the aseptic fill, finish, and packaging of the ADC final drug product. The joint manufacturing solution is intended to provide speed, reliability, quality ADC manufacturing, and a simplified supply chain, from DNA to finished drug product, for clinical trials through commercial manufacturing.

CordenPharma. In March 2016, CordenPharma announced the completion of expanded development capabilities for mid-scale (up to 20 kg) contained capacity of highly potent and oncology oral dosage forms in its CordenPharma Plankstadt (DE) manufacturing facility in Germany. The new and expanded capability provides customers a complete offering in the contained manufacturing of oral dosage from grams to 150 Kg.

Johnson Matthey. In March 2015, Johnson Matthey, a provider of pharmaceutical services, APIs, and catalyst technologies, announced the completion and commissioning of a new high containment facilities for potent product manufacture at its Edinburgh, UK site (Macfarlan Smith). The facility has the necessary manufacturing controls and procedures in place to produce compounds with occupational exposure limits of less than 30 ng per cubic meter. Johnson Matthey also manufactures highly potent products through its facilities in West Deptford, New Jersey and Devens, Massachusetts.

Infa. In 2015, the Infa Group reported that LABOCHIM SpA received the cGMP Certification for its new multipurpose high potent API plant. The new kilo laboratory operates according to cGMP, with a capacity of up to 2.5 Kg/batch size and manufacturing capabilities ranging from a hundred grams to tens of kilograms of both advanced intermediates and APIs, classified from OEB3 to OEB5.

MilliporeSigma. In 2015, SAFC Commercial, Sigma-Aldrich Corporation’s custom manufacturing services business unit, completed the expansion of its St. Louis, Missouri facility to support commercial-scale ADC manufacturing. In 2015, Merck KGaA acquired Sigma Aldrich for $17 billion and later rebranded its life-sciences business as MilliporeSigma in the US. Also in 2015, SAFC expanded commercial capacity for highly active manufacturing and storage at the company’s Madison, Wisconsin facility. The St. Louis expansion complements other recent additions in ADC capabilities, including the announcement of SAFC’s ADC Express service for preclinical ADC and bioconjugation services, and a collaboration with Baxter BioPharma Solutions for formulation and fill/finish services that was formed in 2014.

Novasep.  Novasep is expanding with the addition of a fully integrated ADC facility at its Le Mans site in France. The new facility will enable Novasep to complement its current ADC offering with full bio-conjugation services. The facility is planned to be commissioned in the second quarter of 2016. It will provide contract manufacturing in batch sizes from a few milligrams to 600 g to ADC drug developers during clinical trial and commercial development phases. The expansion is part of Novasep’s EUR 10 million ($11 million) investment in clinical and commercial-scale ADC conjugation.

Piramal. In November 2015, Piramal Healthcare opened a new £2 million ($3 million) ADC manufacturing suite at its facility in Grangemouth, Scotland, according to the Scottish Enterprise, which is the economic development arm of Scotland. The firm received a £200,000 ($304,000) Scottish Enterprise RSA grant towards the building of the facility, which created 20 jobs.

Regis Technologies. In August 2015, Regis Technologies, a contract provider of custom synthesis and separation services, started up a new potent compound suite (PCS) at its 36,000 square foot, cGMP facility in Morton Grove, Illinois. The PCS addition provides for small-molecule cGMP manufacturing of potent compounds up to about one kilogram per batch. Regis’ new PCS includes isolators, laminar flow hoods, and local exhaust ventilation appropriate for potent compound handling.

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