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CMOs and CDMOs expanded their services and facilities in the summer of 2019.
Contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs) are constantly expanding, investing, and merging in order to provide their clients with the latest advancements and breakthroughs in services and technology. This article explores recent facility expansions and industry partnerships.
In July 2019, Lonza Pharma & Biotech announced a binding contractual commitment for the purchase of a sterile drug product fill/finish facility from Novartis (1). The facility, located in Stein, Switzerland, will be the first sterile product finish/fill facility in Lonza’s network for clinical supply and commercial launch.
The current good manufacturing practice (cGMP)-approved facility, which became operational in 2009, has been used for sterile clinical drug product manufacture; it comes equipped with classified cleanroom areas, office, lab, utilities, and storage space. According to a press statement, Lonza will continue to produce drug products for Novartis while providing additional capacity for pharma and biotech customers for development, testing, and manufacturing for parenteral medicines. The facility can produce liquid and lyophilized dosage forms in up to 200L volumes.
In June 2019, Catalent agreed to purchase Bristol-Myers Squibb’s oral solid, biologics, and sterile product manufacturing and packaging facility in Anagni, Italy (2). The 19,300-m2 facility, located 100 kilometers southeast of Rome, opened in 1966. The site is used to manufacture and package cardiovascular, neuroleptics, anticancer, metabolic and anti-inflammatory medicines, non-penicillin-based antibiotics, antivirals, and analgesics. Catalent reports it will continue to manufacture Bristol-Myers Squibb’s current product portfolio at the site.
Cambrex has revealed that it is expanding its solid form screening and crystallization process development facility in Edinburgh, Scotland to add supplementary laboratory space that will double the current footprint. In a July 30, 2019 press release, the company revealed that the expansion will enable recruitment of 40 more scientists, adding to the already employed 50, and will also allow for potential future growth (3). The expanded facility fit out is expected to commence late August 2019, and the company has set a target time for completion as the end of the year.
“This strategic expansion, the increase in headcount, and the investment in new equipment will enable us to serve more customers in the solid-state screening market,” commented Mark Benger, Edinburgh site director, Cambrex, in a press release. “We have increasingly been asked by clients for additional services such as larger-scale crystallization, and we will now be able to provide these as well as adding greater efficiency and capacity at the Edinburgh site.”
The expanded facility will feature additional instruments and reactors for large-scale crystallization studies and solid form screening capabilities. Furthermore, the company states that plans are in place for the installation of new ultra-high-performance liquid chromatography and gas chromatography instruments, as well as additional process analytical technology tools.
STA Pharmaceutical Co., Ltd., (WuXi STA), a subsidiary of WuXi AppTec, announced in July that its Analytical Service Unit (ASU) in Shanghai and its API process R&D and manufacturing facility in Changzhou passed FDA inspections (4). According to a July 23, 2019 press statement, the company has passed seven FDA inspections since 2013 and has produced branded drugs marketed in 95 countries. Its ASU gives clients access to analytical method development, validation, and testing services from preclinical to commercial, and its API process R&D and manufacturing facility produced a variety of new technology platforms such as spray dried dispersion, continuous processing, oligonucleotides, and peptides.
“It’s a point of great pride that our quality systems allow us to be inspected at short notice by any applicable regulatory agency in the world. In this case, we received two separate inspection notices from FDA only seven days and five days in advance of the inspections, respectively. It’s an endorsement of the real time monitoring and quality culture we run across all parts of the company,” said Mei Hao, vice president of Quality at WuXi STA, in a press statement. “It’s another key example of the rigorous nature of our global standard quality systems. It is also another milestone for our platform, and in our efforts to have geographically integrated capabilities for both drug product and drug substance.”
Catalent is expanding the company’s global spray drying capacity through an agreement with Sanofi Active Ingredient Solutions, which gives Catalent access to spray drying manufacturing equipment at Sanofi’s Haverhill, United Kingdom facility (5). This agreement, announced on July 9, 2019, gives Catalent access to the Niro (GEA) PSD2 and PSD4 spray driers at the facility for customer projects. The facility includes clean area facilities for solvent and aqueous processing of potent or non-potent drug formulations, a secondary vacuum dryer, and integrated quality control and analytical capabilities. Catalent reports that the company can now offer spray drying solutions from early-phase development through commercial finished dose form manufacturing in Europe.
Earlier in 2019, Catalent announced a $40-million investment in its Winchester, KY facility, which includes commercial-scale spray drying with high-potent handling capabilities and other increases to the site’s capacity.
In July 2019, Lonza completed a $15-million expansion of its oral solid-dose (OSD) development and manufacturing capabilities at its Tampa, FL site (6). The expanded site will integrate services across early-stage product development, clinical trial material manufacture, and commercialization.
A new product development and quality control laboratory area adds 13 processing suites. Two new commercial packaging suites feature low-humidity environments and serialization for tracking and tracing of commercial products.
New manufacturing suites and dedicated sampling and dispensing areas capable of handling highly potent compounds were also added. In addition, Lonza renovated the cGMP manufacturing cleanroom facility and 25,000 ft2 of the existing cGMP OSD manufacturing cleanroom facility.
Lonza also announced an expansion of its Visp, Switzerland facility after the approval of an antibody-drug-conjugate (ADC) produced at the site. This is the third ADC approved from the bioconjugation facility, according to a July 24, 2019 press statement (7). The additional space will provide customers with launch and commercial manufacturing and will serve the early clinical phase market for bioconjugates.
The company is currently working on bringing bioconjugates to market, specifically developing and manufacturing expression systems with site-specific integration vectors to a simplified supply chain with the option of all elements under the same quality system. By 2020, all materials will be located at a single site through IbexTMSolutions and the highly-potent API facility.
“With 11 INDs completed, and now three out of five commercially available ADCs supported by our bioconjugation facility, we see the need to expand in readiness for the new wave of therapies our customers are developing,” said Karen Fallen, head of Mammalian and Microbial Development and Manufacturing for Lonza, in a press statement. “Many bioconjugates are on expedited programs, and the existing expertise at the facility, combined with proximity to clinical and commercial manufacturing of antibody, linkers and payload, will reduce risk and increase speed on the path to market.”
Fujifilm Irvine Scientific is planning to open a third manufacturing facility in Tilburg, The Netherlands. The new facility will support bioproduction and cell- and gene-therapy markets (8). The new facility, part of Fujifilm Manufacturing Europe’s center, will support cGMP manufacturing of annual component-free, dry powder media, liquid media, and downstream bioprocessing liquid.
On June 20, 2019, CDMO Piramal Pharma Solutions announced the opening of a new wing at its Riverview, MI, site, into which the company has invested $10 million to upgrade (9). The new wing will produce high-potency APIs (HPAPIs) with low occupational exposure levels (OELs).
The upgrade includes a new quality control (QC)/analytical lab and two kilo-labs in addition to a doubling of the office space to support growth at the Riverview site. To date, “the Riverview site has had the containment capability and engineering controls to safely handle HPAPIs with OELs down to 1mcg/m3,” at scales ranging from grams to approximately 250 kilos, according to the company.
The new wing, with its two kilo-labs and QC/analytical lab, strengthens the company’s position in this area. “The new wing is designed with the required engineering controls and containment solutions to handle HPAPIs with OELs <1mcg/m3 and as low as ~20ng/m3.” Materials will primarily be produced in this new wing at kilo-lab scales, and significant amounts of <5 kilos can also be produced.
In July 2019, Catalent Biologics announced that it has entered into a long-term strategic agreement to develop and manufacture an AveXis gene therapy treatment for spinal muscular atrophy (SMA), Zolgensma (onasemnogene abeparvovec-xioi) (10).
Under the terms of the agreement, Novartis company, AveXis, will have dedicated manufacturing space at a new commercial manufacturing center near Baltimore–Washington International Airport, which has been established by Paragon Gene Therapy-a unit of Catalent Biologics. In addition, Paragon Gene Therapy will provide process development for the clinical supply of additional viral therapies within the AveXis pipeline.
Zolgensma is a gene therapy that has already been approved by the US FDA for the treatment of SMA and includes treatment of patients who are pre-symptomatic at diagnosis. The therapy works by replacing the defective or missing SMN1 gene, which halts disease progression, with a one-time intravenous infusion.
This agreement builds on Catalent’s previous investments in the gene therapy area. In May 2019, the company purchased Paragon Bioservices. And in June 2019, Catalent announced that the Paragon Gene Therapy unit would purchase the vaccine manufacturing equipment and facility assets and assume the leases of two Novavax product development and manufacturing facilities in Gaithersburg, MD (11).
More than 100 Novavax manufacturing and quality employees will transfer to Paragon. In addition, the companies announced an agreement in which Paragon will provide process development and manufacturing services for some Novavax programs.
In the press statement, Novavax noted that the approximately $18 million sale will enable the company to focus on advancing two products, NanoFlu and ResVax, through clinical development and regulatory review.
“This alliance is a true win-win-win for Paragon, Novavax and our employees,” said Stanley C. Erck, president and chief executive officer of Novavax, in the press statement. “This mutually beneficial transaction allows Paragon to quickly support the growth of its gene therapy development and manufacturing business and simultaneously offers Novavax a strategic and cost-effective approach to addressing its manufacturing needs into the future.”
In more Paragon news, Amicus Therapeutics, Inc. and Paragon Gene Therapy entered into a strategic manufacturing agreement in July for clinical manufacturing capabilities and capacity for multiple active preclinical lysosomal disorder programs currently in development in collaboration with the University of Pennsylvania (Penn) (12).Penn will collaborate with Amicus throughout the process, and current research and development production related to active preclinical lysosomal disorder programs will be transferred to and developed at Paragon.
1. Lonza, “Lonza to Acquire Sterile Fill and Finish Facility from Novartis,” Press Release, July 1, 2019.
2. Catalent, “Catalent To Purchase Bristol-Myers Squibb Manufacturing Facility In Anagni, Italy” Press Release, June 19, 2019.
3. Cambrex, “Cambrex to Double Size of Edinburgh Solid Form Screening Facility,” Press Release, July 30, 2019.
4. STA Pharmaceutical Co., “WuXi STA Shanghai & Changzhou Facilities Pass US FDA Inspections,” Press Release, July 23, 2019.
5. Catalent, “Catalent Extends Global Commercial Spray Drying Capabilities In Europe,” Press Release, July 9, 2019.
6. Lonza, “Extensive Expansion at Lonza’s Tampa Site Provides Streamlined Services for Solid Oral Dosage Forms,” Press Release, July 9, 2019.
7. Lonza, “Lonza Expands Bioconjugation Facility and Announces Approval of Third Commercial ADC,” Press Release, July 24, 2019.
8. Fujifilm, “FUJIFILM Irvine Scientific Announces Construction of a New Cell Culture Media Manufacturing Site in Europe,” Press Release, July 2, 2019.
9. Piramal Pharma Solutions, “Piramal Pharma Solutions Invests $10 million USD to Expand its High Potency API Capability in its Riverview Facility in US,” Press Release, June 20, 2019.
10. Catalent, “Catalent Biologics Announces Agreement To Provide Additional Production Of Approved Gene Therapy Treatment For Spinal Muscular Atrophy,” Press Release, July 16, 2019.
11. Novavax, “Novavax and Catalent Biologics Enter Strategic Partnership: Allowing Catalent Biologics to Expand Gene Therapy Footprint with Acquisition of Novavax’ Manufacturing Assets and Capabilities,” Press Release, June 27, 2019.
12. Amicus Therapeutics , “Amicus Therapeutics and Catalent Biologics Enter Strategic Partnership for Gene Therapy Development and Manufacturing,” Press Release, July 2, 2019.
Supplement: Outsourcing Resources
When referring to this article, please cite it as, “Pharma Contract Market Update," Pharmaceutical Technology Outsourcing Resources Supplement (August 2019).