Thermo Fisher Forms JV in China; Fareva To Acquire Sterile-Mfg Sites
The latest from CDMOs, CMOs, and suppliers featuring Thermo Fisher Scientific, Fareva, Eurofins CDMO, Lonza, Dalton Pharma Services, Rondo-Pak, Aphena, and others.
Biologics Manufacturing
Thermo Fisher, Innoforce Form JV for Biologics, Sterile Facility
Thermo Fisher Scientific and Innoforce Pharmaceuticals, a Hangzhou, China-based company, have signed a joint venture agreement to establish a new pharma services facility in Hangzhou, China, for integrated biologics and sterile drug development and manufacturing.
The new facility will become part of Thermo Fisher’s global pharma services network, which includes services for drug-product development, biologics manufacturing, sterile fill–finish, clinical trials packaging and logistics. The new facility is expected to be completed in 2022.
Source: Thermo Fisher Scientific and Innoforce Pharmaceuticals
Roche, Cevec Pharmaceuticals in Pact for AAV Mfg Technology
Roche and Cevec Pharmaceuticals, a Köln, Germany-based provider of cell technology for biomanufacturing, have signed a license agreement for use of Cevec’s technology for large-scale manufacturing of adeno-associated virus (AAV) vectors for gene-therapy applications.
Under the agreement, Cevec will grant Roche and Spark Therapeutics, a member of the Roche Group, an option for a non-exclusive license for the development of AAV producer cell lines based on Cevec’s Elevecta technology, a platform for producing AAV gene-therapy vectors. The partnership will provide Roche the rights to use Cevec’s technology for its portfolio of gene-therapy products. Under the license, Cevec will be eligible for payments based on achievement of certain milestones for products as well as royalties on sales of potential products using the technology.
Source: Cevec Pharmaceuticals
Lonza Provides High-Resolution HLA Primary Cells
Lonza reports it now provides a selection of high-resolution human leukocyte antigen (HLA)-typed primary cells spanning all major cell and tissue types. Having previously offered HLA-typing services, Lonza is now providing high-resolution HLA information for a selection of its cell lots.
Lonza says the ready-typed lots eliminate the need for in-house sequencing processes and provide drug developers with a tool for the development of personalized therapies. Nearly 50 different cell types are available from Lonza’s donor inventory with detailed HLA data derived from sequencing techniques. The new offering builds on Lonza’s human primary cell services for cell characterization.
A person’s HLA type is a determinant of the immune system’s response to foreign substances. HLA data is used for preclinical exploration of cross-reactivities and off-target drug effects and in the development of engineered biotherapeutic T cell receptors and antibodies.
Source: Lonza
Formulation Development/Drug-Product Manufacturing
Fareva In Negotiations To Acquire Two Sterile-Mfg Sites
Fareva has announced it is in negotiations respectively with Merck & Co. and Novartis to acquire two sterile-manufacturing sites.
Fareva has entered into exclusive negotiations with Merck & Co. for the acquisition of Merck’s sterile-manufacturing site in Mirabel, France. The site will provide Fareva capabilities to manufacture ophthalmic products (blow-fill-seal single doses), freeze-dried products in vials, sterile liquids, and antibiotic injectables. The site has 350 employees and will add to Fareva’s existing sites for these products at its Valdepharm, Amboise, and Excelvision (Annobay) sites in France.
In addition, Fareva has entered into exclusive negotiations with Novartis for the acquisition of Novartis’ manufacturing site in Unterach, Austria. The site, which has 500 employees, manufactures high-potent prefilled syringes, ampoules, sterile liquids, and freeze-dried vials.
The pending acquisitions add to Fareva’s recent expansions. Earlier this year (July 2020), Fareva agreed to acquire two manufacturing sites in France from Pierre-Fabre Group that the company expects to begin operation by the end of the year (2020).
The Idron, France site has 200 employees and is dedicated to the manufacture of sterile injectable forms (pre-filled syringes, lyophilized and liquid filled vials). The factory has 10 commercial lines and a pilot plant that will begin operating at the end of 2021. The core business of the site is to handle highly potent and biologics entities.
The site in Saint Julien-en-Genevois, France site manufactures monoclonal antibodies and conjugated monoclonal antibodies with high potent actives.
Source: Fareva
Eurofins CDMO Expands with New Drug-Product Mfg Facility
Eurofins CDMO has completed a new drug-product development and manufacturing facility, in Mississauga, Ontario, Canada.
With the expansion, which spans 14,500 square feet, Eurofins CDMO can support development and clinical manufacturing of oral solid dosage forms, including highly potent active pharmaceutical ingredients.
Source: Eurofins CDMO
Dalton Pharma Services Expands Testing Services
Dalton Pharma Services, a CDMO of active ingredients and drug products, has added extractable and leachables testing services to its portfolio of services.
The company now offers consultation services and customized testing services for determining extractables and leachables on container-closure systems.
Source: Dalton Pharma Services
Packaging
Aphena Expands with Cold-Chain Storage, Biologics Packaging
Aphena Pharma Solutions, a CDMO and provider of contract packaging services, has expanded cold-chain storage and large-scale biologics packaging and distribution in a new, 500,000-square-foot property. The new facility is part of a recently announced $21-million expansion.
Within the new space, Aphena has dedicated 47,000 square feet to cold-chain storage, with 14,000 pallet spaces available. This space features: redundant power supplies with a failover compressor; temperature mapping and monitoring; automatic alarm notification; and chilled storage and distribution with temperatures.
Source: Aphena Pharma Solutions
Rondo-Pak To Expand with Equipment Investments
Rondo-Pak LLC, a joint venture with Körber Pharma group (formerly Körber Medipak Systems), is expanding capacity at its primary facilities in Camden, New Jersey and San Juan, Puerto Rico, through infrastructure investment.
The most recent additions are for specialty packaging, such as cartons incorporating child resistance, tamper evidence, crash lock or auto bottoms, and inner partitions. The new equipment includes a Koenig & Bauer Iberica Optima 106 Die-Cutter and a Bobst Expertfold 110 Folder-Gluer
Source: Rondo-Pak
Evotec Expands UK Site into R&D Center
Evotec, a Hamburg, Germany-based drug-discovery and development company, has announced plans to expand its existing campus at Milton Park in Abingdon, Oxfordshire, UK, into a co-located discovery and development center.
The expansion will add a new building, which will house up to 100 biologists by the end of 2020 and will bring together key functions for small-molecule discovery and up to commercial development.
The campus will have the co-location for in vitro pharmacology and protein sciences, structural biology, drug metabolism and pharmacokinetics, computational, synthetic, and medicinal chemistry, formulation sciences, development chemistry, and active pharmaceutical ingredient manufacture.
With over 600 employees on site, Evotec’s expanded campus, the Dorothy Crowfoot Hodgkin Campus, joins Evotec’s sites in Toulouse, France and Verona, Italy as one of three integrated sites for R&D.
Source: Evotec
