Piramal To Acquire Solid-Dosage Mfg Facility; Cytiva, Sharp ExpandBy
The latest from CDMOs, CMOs, and suppliers featuring Piramal Pharma Solutions, Cytiva, Sharp, Thermo Fisher, Siemens, Evotec, Honeywell, and Bavarian Nordic.
Cytiva Upgrades Massachusetts Contract Biomanufacturing Site
Cytiva, the new name of GE Healthcare Life Sciences following Danaher’s $21.4-billion acquisition of GE Healthcare Life Sciences in April 2020, has completed a renovation to its contract biomanufacturing and process development site in Marlborough, Massachusetts.
The upgraded facility is 60,000 square feet and has bioprocessing capabilities ranging in scale from 10 L to 2,000 L. Cytiva’s biomanufacturing services provide preclinical through Phase II development and manufacturing.
Bavarian Nordic Enters $13.9-M Pact with Janssen for Ebola Vaccine Mfg
Bavarian Nordic, a Kvistgaard, Denmark-based company, has entered into a supply contract, valued at $13.9 million, with Janssen Vaccines & Prevention B.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, to manufacture and deliver the bulk drug substance of Janssen’s MVA-BN Filo vaccine, which Janssen has licensed as part of its Ebola vaccine regimen.
Manufacturing of the vaccines will be initiated in 2020, but supply and invoicing will not occur until 2021. The contract builds on Bavarian Nordic’s existing collaboration with Janssen under which Bavarian Nordic has previously manufactured more than 2 million doses of MVA-BN Filo.
In May 2020, the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion recommending approval of the Ebola vaccine regimen, which consists of two components, Ad26.ZEBOV, which is given first, and MVA-BN Filo, which is administered approximately eight weeks later as a second vaccination. The final approval is pending decision by the European Commission.
Source: Bavarian Nordic
Siemens, Exyte Partner for Modular Biomanufacturing Facilities
Siemens, a process automation company, and Exyte, a provider of facility design and construction services, have partnered to offer modular and scalable biomanufacturing facilities for biopharmaceutical and cell- and gene-therapy production.
Siemens provides products and services for process automation and digitalization, and Exyte offers modules and technology used in facility construction. Currently, the first buildings with Siemens’ technology and Exyte’s modules are being designed for cell- and gene-therapy manufacturing and biologicals production in China and Europe.
Gemini Bio Opens New Cell-Culture Media Mfg Facility
Gemini Bioproducts, a West Sacramento, California-based supplier of cell-culture reagents, has opened a new manufacturing facility in West Sacramento, California to support the production of cell-culture media, sera, buffers, and other reagents with products that serve the cell and gene therapy market. The 25,000-square-foot cGMP facility, with cleanroom suites, cold storage, warehouse, and administrative space, will quadruple production capacity.
Gemini Bio recently announced that it was awarded a $3.6-million federal government contract to supply products in support of the demand for COVID-19 testing. Gemini Bio says it will be supplying reagents in the areas of viral transport media, phosphate buffered saline, and saline solution, and is using its new facility to support the effort.
Source: Gemini Bio
Formulation Development-Drug Product Manufacturing
Piramal Pharma To Acquire G&W’s Solid Oral Dosage Facility
Piramal Pharma Solutions (PPS), a CDMO of active pharmaceutical ingredients (APIs) and drug products, has 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 also says it intends to offer high-potency drug manufacturing capabilities at the site.
The transaction closure is subject to customary pre-closing conditions. Under the agreement, PPS would acquire at closing a 100% stake in the entity that operates the facility and owns the related real estate
Source: Piramal Pharma Solutions
Sharp Invests $1.2 M To Expand Commercial Packaging
Sharp, part of UDG Healthcare and a provider of contract packaging and clinical supply services, has invested £1 million ($1.2 million) in a commercial expansion project at its site in Rhymney, UK. The Rhymney facility first opened in late 2019 as a clinical packaging center of excellence.
The capacity expansion included new primary and secondary packaging rooms as well as installation of blistering equipment and automated cartoners. The new lines feature in-line conveyor systems and automatic blister feeding. Commercial blister production at the site is scheduled to begin this month (June 2020).
Sharp says it is planning to introduce new serialization, aggregation and authentication equipment with further investment to support service delivery and future growth within the company. Commercial blister production at the site will begin in June 2020.
Honeywell To Launch Polymeric Bottles and Vials
Honeywell plans to launch a new pharmaceutical packaging product for oral liquids for human health and sterile injectables for animal health applications.
The product, Aclar Edge, is a polymeric product that is designed as an alternative to glass products and is made by multi-layer extrusion blow-molding technology. It is available in bottles and vials and provides moisture- and oxygen-barrier protection and reduced weight compared to glass, says the company.
The company will begin commercial production in the fourth quarter of 2020 for non-sterilized or gamma-sterilized formats.
Thermo Fisher, Daiichi Sankyo To Co-Develop Companion Diagnostic for Cancer Drug
Thermo Fisher Scientific and Daiichi Sankyo have formed a new collaboration to co-develop a companion diagnostic (CDx) designed to identify non-small cell lung cancer (NSCLC) patients with human epidermal growth factor receptor 2 (HER2) mutations who may be eligible for Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan), a HER2-directed antibody drug conjugate (ADC), currently in Phase II development for HER2-mutated or HER2 overexpressing NSCLC.
Under the agreement, Thermo Fisher will retain rights to commercialize the test and will seek approval from regulatory agencies. The announcement follows a 2018 agreement between the companies to expand the clinical utility of the test in support of clinical trials and drug development programs at Daiichi Sankyo.
The CDX will use Thermo Fisher’s Oncomine Dx Target Test, an in vitro diagnostic test approved by the US Food and Drug Administration (FDA) for NSCLC. It is designed to evaluate multiple biomarkers associated with cancer.
Enhertu was approved in the US in 2019 for treating unresectable or unresectable or metastatic HER2-positive breast cancer in patients who have received two or more prior anti-HER2-based regimens in the metastatic setting. In March 2019, AstraZeneca and Daiichi Sankyo entered into a global collaboration to jointly develop and commercialize Enhertu worldwide, except in Japan, where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is solely responsible for manufacturing and supply.
Source: Thermo Fisher Scientific
Evotec Launches Drug Discovery and Development Incubator
Evotec, a Hamburg, Germany-based drug-discovery and development company, Samsara BioCapital, a life-sciences investment firm, and KCK Ltd., a family investment fund, have launched Autobahn Labs, a virtual incubator that partners with academic and research institutions for early-stage drug discovery and development.
Working in partnership with scientists and university technology-transfer offices, Autobahn Labs identifies and de-risks early-stage research projects and creates jointly owned new companies with investments up to $5 million per project.