Fujifilm Diosynth, Cytiva, GRAM Expand; Pharmaron To Buy AbbVie PlantBy
The latest from CDMOs, CMOs, and suppliers featuring Fujifilm Diosynth, WuXi AppTec, Cytiva, Grand River Aseptic Manufacturing (GRAM), Stevanato Group, and others.
Chemicals/Chemical API Manufacturing
Phlow, USP Form Continuous Mfg Pact for Essential Medicines
Phlow Corporation, a Richmond, Virginia-based pharmaceutical manufacturing company, and the United States Pharmacopeia (USP), a non-profit scientific and standards-setting organization, have formed a strategic alliance to develop a new laboratory that will certify and validate pharmaceutical continuous manufacturing processes for US-manufactured essential medicines. The methods developed through this strategic alliance will be available for use by domestic generics manufacturers to encourage broader adoption of continuous manufacturing.
Phlow is using flow chemistry to produce active pharmaceutical ingredients (APIs) and finished pharmaceutical products. The company recently raised $20 million in Series A Preferred financing to further essential medicines R&D programs and advance manufacturing initiatives.
As part of the alliance, USP scientists will be employed at a new laboratory facility operated by USP that will be developed onsite at the Virginia Biotechnology Research Park, which includes Virginia Commonwealth University’s Medicines for All Institute. Phlow currently uses the advanced manufacturing processes developed by Virginia Commonwealth University’s Medicines for All Institute to produce APIs for essential medicines that are in short supply.
The new USP laboratory will be co-located with the R&D Laboratories at Phlow and the Virginia Commonwealth University’s Medicines for All Institute to support analytical process development and testing. Laboratory facilities and instruments in USP’s Rockville, Maryland laboratory will also be used to expand capabilities and capacity for other analytical and testing projects. The partnership will also create a foundation for product development, technology transfer, and drug application filings and will guide the post-technology transfer verification of APIs, intermediates, and dosage forms.
In May 2020, Phlow was awarded $354 million in funding from the US government for the US manufacturing of medicines needed during the COVID-19 response and future public health emergencies. The total contract value awarded to Phlow is up to $812 million, which includes the four-year base award of $354 million with an additional $458 million included as potential options for long-term sustainability.
LGC Acquires Reference Materials Provider Paragon Scientific
LGC Group, a Teddington, UK-based provider of life-sciences tools, has acquired Paragon Scientific, a Birkenhead, UK-based manufacturer of reference materials.
Founded in 1994, Paragon employs 22 people with two facilities located in Birkenhead.
Source: LGC Group
Fujifilm Diosynth Breaks Ground on Biomanufacturing Facility Expansion
Fujifilm Diosynth Biotechnologies, a biologics CDMO and a subsidiary of Fujifilm Corporation, has broken ground to expand its biologics production facility in Denmark as part of a large-scale cell-culture expansion project. The capital investment of 100 billion Yen ($928 million) from Fujifilm Corporation was previously announced in June 2020.
The expansion will double existing bulk drug-substance production capacity with the addition of 6 x 20,000-liter bioreactors to bring the total to 12 x 20,000-liter bioreactors. The new construction will also include a fully automated fill–finish capability to support large-scale production of up to approximately 35 million units per annum. To support the expanded operations, Fujifilm Diosynth Biotechnologies will add 300 positions in Denmark by the end of 2023.
The expansion investment also includes a new packaging line designed to assemble multiple types of auto-injectors and automatic labelling; these capabilities will be operational in the spring of 2022. The fill–finish production line is expected to be operational by the summer of 2023. As the final step in the construction, the large-scale cell bulk drug-substance expansion is expected to be operational by the end of 2023.
Pharmaron To Buy AbbVie Biomanufacturing Site for $118 M
Pharmaron Beijing, a Beijing-based contract R&D service provider, has agreed to acquire a biomanufacturing site in Liverpool, UK, from AbbVie for $118.7 million.
AbbVie gained the former Allergan site from its $63-billion acquisition of Allergan in 2020. The site employs over 150 staff.
The transaction is expected to close in the second quarter of 2021, subject to customary closing conditions.
This transaction will be synergistic to Pharmaron’s recent acquisition of Absorption Systems, an Exton, Pennsylvania-based non-clinical CRO, for building an integrated cell and gene therapy services platform. The platform offers preclinical research, product development, and commercial manufacturing services for cell and gene therapy products.
WuXi AppTec Acquires Oxgene To Expand Cell and Gene Therapy Mfg
WuXi AppTec, a CDMO of small molecules, cell and gene therapies, and testing services, has completed its acquisition of Oxgene, an Oxford, UK-based contract provider of discovery and biomanufacturing services for cell and gene therapies.
Oxgene will become a fully owned subsidiary of WuXi Advanced Therapies, WuXi AppTec’s cell and gene therapy contract testing, development and manufacturing business unit. Oxgene, which will retain its name, will be WuXi Advanced Therapies’ first facility in Europe.
Cytiva Partners with Indian Govt’ for Biopharma Lab
Cytiva, the new name of GE Healthcare Life Sciences following Danaher’s $21.4-billion acquisition of GE Healthcare Life Sciences in April 2020, is partnering with the State of Telangana in India to open a new biopharmaceutical lab in Hyderabad in Telangana, India.
The 10,000-square-foot lab, to be located in the Genome Valley, will provide biomanufacturing scale-up, professional training, technology evaluation, consultancy services, and infrastructure support for biomanufacturing process development.
Celonic Plans New Biomanufacturing Facility in Switzerland
Celonic, a Basel, Switzerland-headquartered CDMO, has announced a long-term lease agreement for a new biomanufacturing production site and office space spanning 91,500 square feet at the Novartis-operated Life Science Park Rheintal in Stein AG, Switzerland.
Celonic will establish development and GMP production capacities for cell and gene therapies, vaccines, and biopharmaceuticals from early clinical trials through commercialization.
Celonic has plans for a two-phase expansion through the addition of up to 20 cleanroom suites, offices, and laboratories for process development, method development, and quality control services. Celonic aims to open the facility for GMP production in the second quarter of 2022 and plans to create up to 250 new positions.
Matica Bio Breaks Ground for a New Cell and Gene Therapy Facility
Matica Biotechnology, a recently launched CDMO of CHA Biotech, a South Korea-based biopharmaceutical company, has broken ground for a new cell and gene therapy facility in College Station, Texas.
Matica Bio’s 25,000-square-foot facility is scheduled to open in the third quarter of 2021 using a bioreactor-based platform, with access to GMP production slots beginning in early 2022. The new facility will house virus production suites, development laboratories and company offices.
Source: Matica Biotechnology
Formulation Development/Drug-Product Manufacturing
Grand River Aseptic Manufacturing To Expand Finishing, Warehouse Facility
Grand River Aseptic Manufacturing (GRAM), a Grand Rapids, Michigan-based provider of sterile-manufacturing services, has announced plans to expand its finishing and warehouse facility in Grand Rapids.
The finishing and warehouse center is expected to open in the spring 2021. In 2020, GRAM opened a new large-scale filling facility. Earlier this year (January 2021), GRAM announced an investment in additional syringe and vial equipment.
Glatt, Aprecia Enter into 3D-Printing Pact
Glatt Pharmaceutical Services, a provider of equipment and services for solid dosage forms, and Aprecia Pharmaceuticals, a Blue Ash, Ohio-headquartered specialty pharmaceutical company with a three-dimensionally-printed (3DP) platform, have entered into a collaboration to accelerate and expand the use of Glatt’s multiparticulate technologies through Aprecia’s 3DP manufacturing platform.
The collaboration will initially target existing products for modified-release 505(b)(2) brand line extensions as well as new chemical entities. A 505(b)(2) application is a type of new drug application to obtain the approval of a new drug that contains similar active ingredients to a previously approved drug and is used for changes in dosage form, strength, route of administration, formulation, dosing regimen, or new indication.
Stevanato Group Names New CEO, Executive Chairman
Stevanato Group, a Padua, Italy-based producer of containment and delivery products and services, has appointed Franco Moro as Chief Executive Officer (CEO).
Mr. Moro will be replacing Franco Stevanato as CEO, who has held the position since 2010. Mr. Franco Stevanato will assume the role of Executive Chairman of the Board of Directors. As incoming CEO, Mr. Moro will oversee the execution of business development plans to grow and enhance the company’s end-to-end offering for pharmaceutical and diagnostics companies. In his role as Executive Chairman, Mr. Franco Stevanato will focus on long-term business strategy, acquisitions, expansion into global markets, and relations with the Board of Directors.
Mr. Moro was previously Chief Operating Officer and interim Chief Human Resources Officer at Stevanato Group. He has experience in international manufacturing and pharmaceutical industries. He was previously CEO of Fabbrica Italiana Sintetici, a Montecchio Maggiore, Italy-based supplier of pharmaceutical ingredients.
Additionally, Sergio Stevanato has been appointed Chairman Emeritus while Marco Stevanato will remain as Vice Chairman. The changes are effective immediately (as reported on February 22, 2021).
Source: Stevanato Group
Icon To Acquire PRA Health Sciences for $12 Bn
ICON, a contract research organization (CRO), has agreed to acquire PRA Health Sciences, a CRO, in a cash-and-stock transaction valued at approximately $12 billion.
The combined company will be headquartered in Dublin, Ireland, the current headquarters of ICON. Dr. Steve Cutler, Chief Executive Officer (CEO) of ICON, will serve as CEO of the combined company, and Brendan Brennan, Chief Financial Officer (CFO) of ICON, will serve as CFO. Ciaran Murray, currently Non-Executive Chairman, ICON, will serve as the Chairman of the Board of Directors of the combined company. Current PRA Chairman and CEO, Colin Shannon, will join the board post the closing of the transaction along with one additional board member from PRA.
Under the transaction, PRA shareholders will receive per share, $80 in cash and 0.4125 shares of ICON stock. Upon completion of the transaction, PRA shareholders will own approximately 34% of the shares of the combined company and ICON shareholders will own approximately 66%.
The transaction is anticipated to close during the third quarter of 2021.
Thermo Fisher Completes Acquisition of Mesa Biotech in $550-M Deal
Thermo Fisher Scientific has completed its previously announced acquisition of Mesa Biotech, a San Diego, California-based molecular diagnostic company, in a $550-million deal.
Mesa Biotech has developed and commercialized a PCR-based rapid point-of-care testing platform available for detecting infectious diseases, including SARS-CoV-2, the virus that causes COVID-19, influenza A and B, respiratory syncytial virus, and Strep A. The company’s Accula Flu A/Flu B, RSV and Strep A tests have obtained 510(k) clearance and Clinical Laboratory Improvements Amendments waivers from the US Food and Drug Administration. Additionally, the Accula System has received emergency use authorization from the FDA for SARS-CoV-2 in vitro diagnostic testing and is available for use in patient-care settings.
Thermo Fisher will pay approximately $450 million in cash upfront and will pay up to an additional $100 million in cash upon the completion of certain milestones following the close of the transaction. With the closing, Mesa Biotech becomes part of the Life Sciences Solution Segment and is expected to add revenue of approximately $200 million in 2021.
Source: Thermo Fisher Scientific