CDMO/CMO Expansion Update: Solid-Dosage Drug Products

By Patricia Van Arnum - DCAT Editorial Director

September 9, 2020

Solid-dosage products continue to be a mainstay of new drug approvals. How are new drug approvals for solid-dosage products trending? Which CDMOs/CMOs are expanding in solid-dosage development and manufacturing with announcements made thus far in 2020?

New drug approvals and solid-dosage products

Small molecules dominated approvals of new molecule entities (NMEs) in 2019 by the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) and solid-dosage products accounted for a majority of these approvals. Small-molecule drug approvals in 2019 accounted for 79% of all NME approvals, representing 38 of the 48 NMEs approved by the FDA in 2019. Of the 38 small molecules approved by FDA’s CDER in 2019, 26 or 68% were solid dosage products (tablets or capsules) administered by an oral route of administration.

A recent analysis (1) by PharmaCircle LLC, a business intelligence firm specializing in analysis of formulation and drug-delivery technologies and products, provides a further breakdown of recent innovative product approvals to include the following: new molecular entities (NMEs); a new dosage form of an NME or previously approved active (PAA) or; a new combination of NME or PAA actives (note: multi-source products, generics, and biosimilars are excluded) from the US, the European Union (EU), and Japan in 2019. Based on this analysis, as was the case in 2018, oral products represented half (50%) of new product approvals in the US in 2019, according to the PharmaCircle analysis. In the EU, oral products represented 43% of new approvals in 2018 and 42% in Japan. In the EU and Japan, the number of oral and injection products were almost even in 2019: 20 oral products and 21 injection products approved in 2019 in the EU and 25 approvals each for oral and injection products in Japan. In the case of the EU, PharmaCircle notes that this is due to the regulatory approval scope by the European Medicines Agency, which approves new products and dosage form improvement for a relatively limited range of therapeutic indications.

CMDO/CMO expansions in solid-dosage products

Expansion activity among CDMOs/CMOs in solid-dosage development and manufacturing thus far in 2020 has been fairly measured, based on company announcements in this area thus far in 2020. Key expansions are highlighted below.

Piramal Pharma Solutions. In June (June 2020), Piramal Pharma Solutions (PPS), a CDMO of APIs and drug products, agreed to acquire a solid oral dosage drug-product manufacturing facility in Sellersville, Pennsylvania from G&W Laboratories, a South Plainfield, New Jersey-based pharmaceutical company. The Sellersville site covers 31.5 acres of land with over 221,000 square feet of manufacturing space, including 195,000 square feet of GMP area, and employs a workforce of approximately 100 employees. The site features manufacturing and packaging technologies for solid oral dosage forms, liquids, creams, and ointments, quality control and microbiology labs, preformulation and analytical development infrastructure, a pilot lab for research and development, and a temperature-controlled warehouse. The site currently has the necessary controls to support manufacturing of potent solid oral dosage forms. The acquisition adds solid oral dosage-form capabilities (tablets and capsules) for PPS in North America, which until now, for PPS, were all located in the UK and India. PPS says it intends to offer high-potency drug manufacturing capabilities at the site.

Catalent. Last month (August 2020), Catalent announced plans to expand its site in Loma Hermosa, Buenos Aires, Argentina by adding over 11,000 square feet of production space to handle cytotoxic and highly active products for prescription softgel manufacturing. The new facilities, which are due to be completed in December 2021, will include two new manufacturing vessels of 40 L and 300 L, which include an automatic cleaning system and a mixing device suitable for very high viscosity formulations, a capsule-filling line, and six drying tunnels. The expansion will add a capacity of over 10 million doses per annum to the site, which supplies products to the Latin American, US, and European markets.

In addition, in late June (June 2020), Catalent completed a $3.2-million expansion program at its consumer health manufacturing facilities in Strathroy, Canada and Sorocaba, Brazil to include new softgel encapsulation lines at each site. The expansion projects included new softgel encapsulation lines at each site for Catalent’s proprietary Vegicaps plant-based capsule and CosmoPod twist-off capsule technologies. The increased capacity can be used for plant-based vitamins, minerals and supplements using the company’s Vegicaps capsules and for unit-dose beauty care products through its CosmoPod technology. Catalent’s 110,000-square-foot facility in Strathroy, Ontario and its 124,600-square-foot facility in Sorocaba, Brazil provide formulation, manufacturing, and packaging services.

Lonza. In July (July 2020), Lonza announced additional investments in its particle-engineering network to expand jet-milling and spray-dry processing for development at its US and European sites and to enhance processing capabilities. The company reported that development capacity has been doubled at its micronization site in Monteggio, Switzerland with investments for a new glove-box for isolation, upgraded process controls, and expanded operator teams. A new micronization development wing has also been brought on line at the company’s site in Quakertown, Pennsylvania. Additionally, a new pharmaceutical spray dryer dedicated to development projects has been added at the company’s site in Bend, Oregon.

Lonza has also expanded its specialized processing capability within its particle-engineering platform. During the last 12 months (as reported on July 1, 2020), the Monteggio site has revamped its processing assets to allow for 100% segregation of steroids and hormone compounds. Lonza says two new rooms have been designed to reach a proper containment level to meet requirements maintaining a high throughput of the micronization processes. As part of Lonza’s focus on expanded particle-engineering services, the company says an external sale of jet-milling equipment and containment systems will be curtailed, and going forward, the Monteggio-based engineering and technical team will be focused on supporting the delivery of the company’s micronization services.

Metrics Contract Services. In June (June 2020), Metrics Contract Services, the CDMO business of Mayne Pharma, announced an expansion of its Greenville, North Carolina, production facility to support projected growth of Mayne Pharma’s portfolio and third-party contract manufacturing business. The expansion will add 3,760 square feet of production space to the current facility and will consist of three new rooms: one dispensing/flex room, one tablet press room, and one flex room The space will house key equipment, including a Fette FE55 tablet press  a Bosch 720 encapsulator, and a weigh and dispense isolator, all which have containment capabilities for the safe handling of potent products. Construction on the production space was scheduled to begin in August (August 2020) and be operational in early 2021.

Thermo Fisher Scientific. In March (March 2020), Thermo Fisher Scientific provided an update on recent developments in its drug-product capabilities. For solid-dosage products, the company is now providing commercial spray-drying capabilities for molecules with solubility challenges. The company is also providing continuous manufacturing capabilities and new commercial packaging capabilities with smaller production runs for oral solid dosage forms.

LGM Pharma. LGM Pharma, a Boca Raton, Florida-headquartered API supplier, announced in late July (July 2020) that it had acquired the formulation development and drug-product contract manufacturing business of Nexgen Pharma, an Irvine, California-based company developing and manufacturing solid dose, powder, semi-solid, and liquid prescription and over-the-counter drugs. The acquisition brings LGM Pharma’s knowledge in API sourcing, distribution, and supply-chain management with Nexgen Pharma’s drug-product CDMO services. The combined firm will continue to be known as LGM Pharma. With the acquisition, LGM Pharma gains Nexgen’s manufacturing and warehouse distribution facilities and employees in California and Texas along with formulation development, laboratory, and pilot-plant manufacturing employees and facilities in Colorado. In all, LGM Pharma gained 150 employees and more than 100,000 square feet of facilities along with expertise in all aspects of pharmaceutical finished-product development and manufacturing.

Frontida BioPharm. Frontida BioPharm, a Philadelphia, Pennsylvania-headquartered CDMO, reported last month (August 2020) that it had completed a facility expansion to its oral solid-dose manufacturing operations with the commissioning of a highly potent compound contract manufacturing suite for clinical trial materials and commercial products. Key service equipment and set-ups include: a large-scale roller compactor, milling room, bin blender, tablet press, and ingress and egress airlocks with enhanced personnel controls.

Adare Pharmaceuticals. In April (April 2020), Adare Pharmaceuticals, a clinical-stage pharmaceutical company and a provider of pharmaceutical technologies, and a CDMO, acquired Orbis Biosciences, a Lenexa, Kansas-based pharmaceutical technology company with particle-size engineering technology that is used to produce uniform particles in size ranges suitable for use in oral solid dosage forms as well as in injectable and otic dosage forms.

CoreRx. CoreRx, a Clearwater, Florida-based CDMO of solid, liquid and semi-solid dosage forms, reported last month (August 2020) that its new product development center is operational. The site includes nine R&D formulation development and R&D-scale manufacturing suites, nearly 5,000 square feet of analytical laboratory space, as well as capacity for an additional 35 employees to the Clearwater workforce over time. The new 26,000-square-foot space expands the capacity of oral and topical dosage form development group by increasing drug-product volume through several formulation technologies, including blending, roller compaction, wet granulation, fluid-bed drying, spray drying, and extrusion spheronization.

Velesco Pharma. In February (February 2020), Velesco Pharma, a provider of early- and late-stage drug-development services, began operations at its new cGMP clinical manufacturing facility in Wixom, Michigan. This facility operates in coordination with Velesco Pharma’s existing Wixom site, which houses its pharmaceutical research and development laboratories that provide formulation development, analytical method development, and testing services. The new facility replaces and consolidates the company’s existing manufacturing site in Kalamazoo, Michigan. The facility triples the company’s cGMP clinical trial manufacturing capacity and features expanded processing suite space to manufacture a range of non-sterile dosage forms, including liquids, semi-solids, powders, capsules, and tablets, including the capability to handle high-potency compounds.

Upperton Pharma Solutions. Upperton Pharma Solutions, a Nottingham, UK-based CDMO that develops and produces oral and inhalation drug products for clinical trials, reported earlier this year (2020) that it had invested £500,000 ($625,000) to expand its tablet-manufacturing capabilities with the addition of tablet-processing equipment for wet granulation, roller compaction, tablet compression, hardness testing, dedusting, weight sorting and tablet coating. The investment was made in 2019 and is continuing in 2020.

Reference

1. K. Sedo and T. Kararli, “Global Report–2019 Global Drug Delivery & Formulation Report, Part 1,” Drug Development & Delivery, March 2020, https://drug-dev.com/global-report-2019-global-drug-delivery-formulation-report-part-1-a-global-review/.

Editor's Note: This article was updated to include additional information on Metrics Contract Services