Supplier News: Sterling Pharma, Delpharm, Hovione & MoreBy
The latest from CDMOs, CMOs, and suppliers featuring Sterling Pharma Solutions, Aceto, CureVac, Cambrex, IDT Biologika, Exothera, Abzena, Delpharm, CordenPharma, Famar Group, Stevanato Group, Hovione, Pii, and Univar.
Chemicals/Chemicals API Manufacturing
Sterling Pharma To Acquire Novartis API Mfg Facility
Sterling Pharma Solutions, a Dudley, UK-based CDMO of small-molecule active pharmaceutical ingredients (APIs) and intermediates, has agreed to acquire Novartis’ facility in Ringaskiddy, Ireland to expands its global API manufacturing capabilities.
Under the agreement, Sterling will acquire the 111-acre site, which includes three API manufacturing buildings, as well as facilities to support development and scale-up. The site currently manufactures a number of APIs across a range of therapeutic areas, and the deal includes an ongoing supply agreement between Sterling and Novartis from the Ringaskiddy facility. Upon closing, the workforce will transition to Sterling.
The addition of the Ringaskiddy campus will see Sterling’s global network grow to five facilities across the UK, Europe and the US, with a workforce of over 1,000 employees.
Source: Sterling Pharma Solutions
Aceto Acquires Nutritional-Supplements Manufacturers
Aceto, a provider of specialty materials for life-science and advanced technology end markets, has acquired Biotron Laboratories and Talus Mineral Company (affiliated entities collectively referred to as Biotron). Both companies are manufacturers of specialty ingredients for the nutritional supplements industry.
Biotron is known for its technology for producing mineral chelates, which are used in nutritional supplements. Biotron has research and development capabilities and two manufacturing facilities located near its Utah headquarters.
CureVac Launches CMDO Business for mRNA Mfg
CureVac, a Tubingen, Germany-based clinical-stage bio/pharmaceutical company developing messenger ribonucleic acid (mRNA) therapeutics and vaccines, has formed a new subsidiary for the company’s RNA Printer technology that integrates and automates the manufacturing process for GMP-grade RNA vaccines and therapeutics.
The new subsidiary provides a dedicated operational environment for the RNA Printer manufacturing platform. The company will be led by Dr. Markus Bergmann, formerly an executive from the ZF Group, a global technology company, and McKinsey & Company, who joined CureVac RNA Printer GmbH as General Manager on March 1, 2022. Dr. Bergmann started his career as a doctor at the University Hospital in Tübingen, Germany, in the Department of Hematology and Oncology after graduating from University of Heidelberg, Germany, and receiving a Doctor of Medicine in collaboration with the German Cancer Research Center in the field of Immunology.
Cambrex Expands Testing Services for Biologics
Cambrex is expanding its existing biopharmaceutical testing services business by adding 11 additional cGMP laboratories at its Durham, North Carolina, facility to broaden its services for large molecule and viral/cell-based therapeutics.
The expansion includes a range of new instruments supporting nanoparticle size analysis, imaging, qPCR, fluorescent/absorbance plate readers, immunoblotting, mass spectrometry, next-generation sequencing (NGS), chromatography capillary electrophoresis (CE-PDA and FLD), SEC-MALS, and other compendial testing.
These new capabilities apply to a wide variety of bio/pharmaceutical therapeutics, including bacteriophage and mammalian viruses, recombinant proteins, monoclonal antibodies, and nucleic acids. Additionally, Cambrex recently installed a new 600 MHz NMR spectrometer to enhance support for both biopharmaceutical and small-molecule programs.
IDT Biologika, Exothera in Pact for Viral-Vector & Vaccines Mfg
IDT Biologika, a Dessau-Rosslau, Germany-based CDMO, and Exothera, a Brussels, Belgium-based viral vector CDMO launched by Univercells, a technology company specializing in bioprocessing, have entered into a collaboration to develop a large-scale manufacturing process for viral vector-based vaccines.
The feasibility study is focusing on Modified Vaccinia Ankara (MVA) virus as a first example for IDT’s range of vector technologies. Exothera has already transferred IDT Biologika’s upstream process from small to large scale in the NevoLine Upstream platform from Univercells Technologies.
The NevoLine platform incorporates the scale-X structured fixed-bed bioreactor system, which provides options to scale viral production from R&D to commercialization. The collaboration between IDT and Exothera will demonstrate the application and performance of Univercells’ NevoLine platform at full commercial capacity.
Abzena Launches Biologics Consortium
Abzena, a contract manufacturer of biologics and antibody drug conjugates, Alira Health, a clinical research and development consultancy, and Oncodesign, a biopharmaceutical company specializing in precision medicines, have formed a consortium in biologics drug discovery and development.
This joint service offering, DRIVE-Biologics, will use Abzena’s expertise in cell-line development through commercial biomanufacturing, alongside Oncodesign’s pharmacology expertise in oncology and inflammatory diseases, and Alira Health’s services in research and clinical development.
Partners in the consortium will be able to access expertise at all stages of the drug-discovery and development processes, including design, preclinical, clinical and CMC (chemistry, manufacturing, and control).
Formulation Development/Drug-Product Manufacturing
Delpharm Acquires Novartis’ Sterile-Injectable Mfg Facility
Delpharm, a Boulogne-Billancourt, France-based CDMO, has acquired a sterile-injectable production facility in Boucherville, Quebec, Canada from Sandoz Canada. Sandoz is the generics and biosimilars arm of Novartis.
As part of the transaction, Delpharm and Sandoz Canada signed a long-term supply and manufacturing agreement, which ensures that Sandoz Canada will maintain local production of all its Quebec–Canadian origin injectable medicines and will continue to have commercial responsibility for all its products.
CordenPharma To Increase Lipid Mfg Capacity
CordenPharma plans to increase lipid manufacturing capacity at its CordenPharma Chenôve facility, near Dijon, France.
In 2020, the French government launched an initiative to support COVID-19 medicine production and launched a second request for another program, Appel à Manifestation d’Intérêt (AMI), in February 2021 to support COVID-19 research and development projects. CordenPharma Chenôve submitted an accelerated program dossier to increase local lipids manufacturing capacity and was selected by the French government as one of 25 AMI projects that were awarded a total of EUR 585 million ($650 million). With this funding, CordenPharma Chenôve was able to accelerate its manufacturing growth for the production of lipid nanoparticle-(LNP) enabling ingredients, such as highly pure lipids.
CordenPharma made the decision to invest the AMI money toward its lipids platform by expanding CordenPharma Chenôve’s capabilities to include purification technologies. This ongoing program will create approximately 30 new jobs in the facility.
Phase 1 of the investment program was recently completed with the renovation of an R&D laboratory and the addition of several analytical instruments, a mid-scale purification unit, and a newly hired team of experts.
Phase 2 of the investment has also been initiated (as reported on March 1, 2022) , which includes the design and construction of a larger lipid chemistry facility at CordenPharma Chenôve. The additional production capacity will allow CordenPharma Chenôve to provide multi metric tons of lipids by the end of 2022.
Famar Appoints New Chairman
ECM Partners Inc., the major shareholder of Famar Group, a European CDMO, has appointed Peter Prock, a founder and Managing Partner of Albrecht, Prock & Partners, a consultancy, as Famar’s new Chairman of the Board of Directors.
Mr. Prock has held various management roles in the pharmaceutical sector. Prior to forming Albrecht, Prock & Partners in 2016, Mr. Prock was CEO of Polpharma Group from 2013 to 2015, Deputy CEO of Actavis, and Chief Financial Officer of Ratiopharm Group before its acquisition by Teva. Mr. Prock started his career at Sandoz, where he held various positions in Austria, Spain, the US, and Germany. He is a board member of several pharmaceutical companies.
Separately, the Famar Group Board also named Konstantinos Rengis, CEO of Famar, to the company’s Board of Directors. Mr. Rengis has 33 years of experience and has served in several positions, including CEO, Chief Operating Officer and Vice President Operations.
Both appointments were effective immediately as reported on February 28, 2022.
Source: Famar Group
Stevanato Gets $95-M US Gov’t Contract for Vials
Stevanato Group, a provider of drug-containment, drug-delivery, and diagnostic products and services, has received a $95-million contract from the US government to expand vials production in the US.
Under the agreement, Stevanato Group has agreed to expand its planned manufacturing capacity in Fishers, Indiana, for both standard and EZ-Fill vials. Financing from the Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services, is intended to strengthen domestic capabilities in the US for national defense readiness and preparedness programs for current and future public health emergencies. In addition, Stevanato Group has agreed to provide priority access to designated BARDA vaccine and drug development partners, when necessary.
Source: Stevanato Group
Hovione Names New CEO
Hovione’s Board of Directors and the company’s shareholders have approved the appointment of Dr. Jean-Luc Herbeaux, currently Chief Operating Officer at Hovione, as Hovione’s Chief Executive Officer, effective April 1, 2022. Guy Villax, who has been Hovione’s CEO for the past 25 years will now serve as a member of the Board and be a shareholder.
Before joining Hovione in May 2020, Dr. Herbeaux held multiple leadership positions at Evonik, where he last headed the Health Care Business Line.
Pii Names New CEO, President
Pharmaceutics International, Inc. (Pii), a Hunt Valley, Maryland-based CDMO, has appointed John Fowler, currently President and Chief Operating Officer of Piramal Pharma Solutions, as President and Chief Executive Officer of Pii, effective March 7, 2022.
Mr. Fowler has more than 30 years of experience in the pharmaceutical and chemical industries. Prior to joining Piramal, he was the Divisional CEO of the Global Fine Chemical business at Johnson Matthey.
Source: Pharmaceutics International Inc
Univar Opens Center for Specialty Chemical Innovation
Univar Solutions a global chemicals and pharma ingredients distributor, has opened a center in Essen, Germany, to support ingredient and specialty chemical innovation and product formulation application development across Europe and globally.
The Solution Center serves as the flagship facility for Europe and as one of the company’s center points for a global hub-and-spoke model of innovation.
The Solution Center consists of 700 square meters, including laboratories, a pilot plant, meeting rooms, and offices. End-product applications expected to be developed at the facility include: haircare products, toiletries, skincare products, color cosmetics, topicals, tablet coatings, ointments, dishwashing formulations, and building materials.
Source: Univar Solutions