Lonza, Flamma, Regis, Fujifilm Irvine Scientific, and Catalent ExpandBy
The latest news from CDMOs, CMOs, and suppliers featuring news from Lonza, Flamma, Regis Technologies, Evotec, Fujifilm Irvine Scientific, GenScript Biotech, Catalent, GenScript Biotech, Wasdell and Marken.
Chemicals/Chemical API Manufacturing
Lonza Expands Bioconjugation Facility in Switzerland
Lonza has begun the expansion of its bioconjugation facility in Visp, Switzerland, and reports the commercial approval of a third antibody-drug-conjugate (ADC) produced at the site. Lonza’s Visp site completed a successful FDA inspection for commercial manufacture of a recently approved ADC, the third to be commercialized from the bioconjugation facility. The existing capacity at the Visp facility will cover the current needs for production of this fast-tracked therapy.
The company also began an expansion at the site that will span the next two years. The additional capacity, with contracts already in place, will provide current and future customers with launch and commercial manufacturing and will serve the clinical-phase market for bioconjugates.
Flamma Acquires Teva’s API Facility in Philadelphia
Flamma Group, a contract development and manufacturing organization for small-molecule active pharmaceutical ingredients (APIs), has acquired Teva Pharmaceuticals’ current good manufacturing practice (cGMP) Chemical Synthesis Center in Malvern, Pennsylvania in the Philadelphia area.
The 40,000-square-foot facility has the following: a cGMP pilot plant with hydrogenation capabilities and wet-milling; six standard cGMP kilo lab suites; one cGMP highly potent API kilo lab suite with isolators (classified Band 4 by SafeBridge); 22 fume hoods; an analytical development lab; quality-control lab; and additional space for future expansion for any necessary analytical, chemistry, and/or warehouse needs. The site previously handled controlled drug substances (Schedule II to IV), and Flamma says it will look to reactivate the necessary licenses.
The site will initially be dedicated to the development and production of APIs ranging from pre-clinical/clinical (Phase I to III) up to commercial phase (after future FDA inspections) with the scale being dependent on the forecasted quantities, according to Flamma.
The Pennsylvania site joins other sites. Flamma has two cGMP facilities in Italy, located near Milan: Chignolo d’Isola and Isso. The Chignolo site is also where the company’s headquarters are located. Additionally, Flamma is established in China, where its 100% owned Chinese subsidiary, Flamma Honkai, operates in Dalian in the Liaoning Province.
The company says through its Flamma Academy model, it will be able to bring in research and development (R&D) chemists from Italy and China to spend time in the Philadelphia-area labs. Flamma says it plans to grow the site to 60 employees by 2023.
The acquisition comes on the heels of the addition of a cGMP workshop at Flamma Honkai and the recent receipt of a cGMP drug-manufacturing license from China’s Food and Drug Administration. Flamma’s Italian sites also recently added a new cGMP kilo lab as well as a high-containment lab to handle genotoxic materials. Flamma says it intends to invest approximately $10 million to expand its R&D capabilities with the addition of a new R&D building at its Chignolo d’Isola headquarters soon.
Source: Flamma Group
Regis Technologies Launches Solid-State Chemistry Services
Regis Technologies, a contract development and manufacturing organization (CDMO) for small-molecule active pharmaceutical ingredients (APIs), has announced a new capability for solid-state chemistry.
The solid-state chemistry service will provide salt, cocrystal, and polymorph screening and selection activities to provide suitable crystallization processes during all development phases The company’s Solid-state Chemistry Director, Dr. Ronald L. Mueller, has developed a dedicated lab with new equipment for a team of solid-state chemists.
Source: Regis Technologies
Evotec Completes Acquisition of Just Biotherapeutics; Forms Biomfg Pact with Teva
Evotec, a drug-discovery alliance and development partnership company, has completed its previously announced acquisition of Just Biotherapeutics, an integrated design company focused on technologies for biomanufacturing. The deal closing was announced on July 3, 2019.
Under the deal, Evotec will pay a total consideration of up to $90 million, including potential earn-outs in the next three years. The initial consideration upon closing was $60 million, subject to customary net debt and working capital adjustments. The acquisition of 100% of the issued and outstanding equity interests of the company will be paid in cash to a syndicate of institutional investors of ARCH Venture Partners, Merck & Co., Lilly Asia Ventures and the Bill & Melinda Gates Foundation.
With the acquisition, Evotec will expand its US footprint with the addition of a biologic development and manufacturing site in Seattle, Washington. Just Biotherapeutics has approximately 95 employees and had 2018 revenues of approximately $20 million.
Late last month (June 2019), Just Biotherapeutics entered into an agreement with Teva Pharmaceuticals to design and develop a high-yielding manufacturing process for one of Teva’s products in development.
The collaboration will be enabled by a cross-functional team based at Just’s facility in Seattle, working with Teva’s specialty research and development team based in West Chester, Pennsylvania.
Source: Just Biotherapeutics
Fujifilm Irvine Scientific To Open Cell-Culture Media Mfg Site in the Netherlands
Fujifilm Irvine Scientific, which develops and manufactures cell-culture media, reagents, and medical devices for researchers and clinicians, has announced plans to open a third manufacturing facility for cell-culture media manufacturing in Tilburg, the Netherlands.
The 250,000-square-foot facility will be located within Fujifilm Manufacturing Europe B.V., one of the largest production centers for the company outside of Japan. The space will support cGMP manufacturing of animal-component-free, dry-powder media, liquid media, and downstream bioprocessing liquids.
The expansion adds production capacity for the company of 320,000 kilograms per year for dry powder and 470,000 liters per year for liquids. The company’s current capacity is greater than 1,000,000 kilograms per year of dry powder. Water for injection will also be manufactured on the premises.
Work on the new manufacturing site began in July 2019, and the site is expected to be commissioned in the second half of 2021. Fujifilm Irvine Scientific has sites in the US and Japan.
Source: Fujifilm Irvine Scientific
Chinese CDMO GenScript Biotech Launches Biologics R&D and Production Center
GenScript Biotech, a contract development and manufacturing organizations (CDMO) in China, has formally put into operation its biologics research and development (R&D) and production center in Nanjing. This follows the groundbreaking of its commercial manufacturing center in Zhenjiang, Jiangsu Province.
Construction of the 9,300-square-meter biologics R&D and production center was completed in June 2019. The company says that the design and infrastucture of all facilities meet US, EU and Chinese GMP requirements. Once put into production, the center is expected to meet the production needs of all types and quantities of preclinical and Phase I clinical samples.
GenScript’s Biologics GMP production center in Nanjing is scheduled to be put into production in 2020, with an accumulated production capacity of up to 2,600 liters, meeting the production needs for samples in Phase I and II clinical stages. Phase I of the planned 150,000-square-meter clinical and commercial production center in Zhenjiang is now under construction. Once completed, the center will have an accumulated production capacity of 47,600 liters for cell therapy, gene therapy and antibody R&D.
Source: GenScript Biotech
Formulation Development/Drug Product Manufacturing
Lonza Completes $15-Million Expansion for Oral Solid Dosage Drugs
Lonza has completed a $15-million multi-phase expansion of its solid oral dose development and manufacturing capabilities and capacity at its site in Tampa, Florida. The expansion will enable the Tampa site to provide services across early-stage product development, clinical trial material manufacture and commercialization of drug products.
As part of the multi-year investment, the site now has a new fully equipped product development and quality-control laboratory area with 13 processing suites and two new packaging suites that can support commercial packaging, including low-humidity environments and serialization for tracking and tracing of commercial products. Lonza also added new manufacturing suites and dedicated sampling and dispensing areas capable of handling highly potent compounds.
In addition, Lonza expanded and renovated the cGMP manufacturing cleanroom facility as well as completely renovated 25,000 square feet of the existing cGMP oral solid dosage manufacturing cleanroom facility.
Catalent Expands Spray-Drying Operations in UK
Catalent has expanded capacity of its global spray-drying operations through an agreement with Sanofi Active Ingredient Solutions, an industrial platform of Sanofi, under which Sanofi will provide Catalent with access to spray-drying manufacturing services for Catalent’s customers at Sanofi’s facility in Haverhill, UK.
This agreement extends Catalent’s global spray-drying offering by making available to Catalent and Catalent’s customers use of existing Niro PSD2 and PSD4 spray dryers at the facility. These spray dryers are supported by clean area facilities for both solvent and aqueous processing of potent or non-potent drug formulations as well as a secondary vacuum dryer. With the agreement, Catalent will have access to the facility’s quality control and analytical capabilities with scientific support resources, enabling an end-to-end approach for customers. Catalent is now able to offer spray-drying from early-phase development through clinical supply and fully scaled-up commercial finished dose form manufacturing in Europe.
In May 2019, Catalent announced a $40-million investment in its Winchester, Kentucky facility that includes adding commercial-scale spray drying with high-potent handling capabilities as well as other increases to the site’s capacity and its formulation and controlled-release tablet and capsule manufacturing capabilities. This facility will work alongside the Sanofi Haverhill facility to enable transfer and scale-up of spray-drying programs from Catalent’s specialized early-stage clinical development sites located in San Diego, California and Nottingham, UK.
Wasdell’s New HQ in Ireland Now Operational
The Wasdell Group, a contract provider of technical, manufacturing, packaging and storage/distribution services, has announced its new headquarters in Dundalk, Ireland, has begun operations. The facility has received its Manufacturer’s/Importation Authorization license from Ireland’s Health Products Regulatory Authority (HPRA).
The 90,000-square-foot facility houses 11 modified production suites and temperature-controlled high-bay warehouses, which increases Wasdell’s capacity in clinical and commercial packaging, distribution and logistics and qualified person (QP) services.
Building work commenced in September 2018. The site also underwent a successful HPRA inspection in late 2018, which granted the company permission to perform QP batch certification and release of pharmaceutical products into Europe.
Wasdell also has facilities in Swindon, Northampton and Newcastle, UK.
Marken Acquires Three Logistics Companies in Europe
Marken, a subsidiary of UPS and supply-chain organization for clinical supplies and samples, has acquired three logistics companies in Europe: HRTL based in Italy along with two additional companies in Austria and Hungary under the respective names of HETO and Der Kurier. Together the group operates with offices in Vienna, Milan, Rome, and Gyor (near Budapest) to deliver 7,000 clinical trial shipments per month. This brings Marken’s total network of sites to 51, including 10 GMP qualified clinical storage depots.