Supplier News: Bachem, PCI, Lonza, Cytiva & More
The latest from CDMOs, CMOs, and suppliers featuring Bachem, PCI Pharma Services, Cytiva, Grifols, Lonza, Thermo Fisher, Charles River Laboratories, Bora Pharmaceuticals, Stevanato Group, Ardena, Kindeva Drug Delivery, Coriolis Pharma, Lubrizol Life Science Health, Waters. Highlights below.
Chemicals/Chemical API Manufacturing
* Bachem, Lilly in $100-M Oligonucleotides Mfg Pact
* Bora Pharmaceuticals Acquires Biomanufacturing Mfg Facility
* Cytiva To Open Mfg Facility for Single-Use Kits for Cell Therapies
* Grifols Completes Acquisition of Biotest
* Thermo Fisher, Charles River Join Robotic Cell-Therapy Mfg Consortium
Formulation Development/Drug-Product Manufacturing
* PCI Investing $100 M To Expand Fill–Finish, Lyophilization Capacity
* Kindeva Drug Delivery To Acquire iPharma Labs
* Ardena Expands Dry-Granulation, Spray-Drying Capabilities
* Lonza Adds TiO2-Free Gelatin Capsules
* Lubrizol Life Science Health Launces New Excipient for Parenteral Drugs
* Coriolis Pharma Appoints New CEO
* Stevanato Group in Pact for Auto-Injectors Platform
* Waters, University of Delaware Open Innovation, Research Lab
Chemicals/Chemical API Manufacturing
Bachem, Lilly in $100-M Oligonucleotides Mfg Pact
Bachem, a Bubendorf, Switzerland-based CDMO of peptides and oligonucleotides, has entered into a CHF 100-million ($100.6-million) collaboration with Eli Lilly and Company to develop and manufacture active pharmaceutical ingredients (APIs) based on oligonucleotides.
Under the agreement, Bachem will provide the engineering infrastructure and expertise to implement Lilly’s oligonucleotide manufacturing technology and provide R&D and production personnel at its facilities in Bubendorf, Switzerland, for GMP-grade material for Lilly’s oligonucleotide-based investigational medicines.
Lilly commits to placing manufacturing projects with Bachem over the next seven years (as reported on April 26, 2022). The annual order volume has the potential to achieve around CHF 100 million ($100.6 million), depending on Bachem reaching certain milestones and definite volumes ordered by Lilly.
Bora Pharmaceuticals Acquires Biomanufacturing Mfg Facility
Bora Pharmaceuticals, a CDMO of drug products, has acquired a biomanufacturing facility from Eden Biologics, a Zhubei, Taiwan-based biopharmaceutical company. Bora Pharmaceuticals recently launched Bora Biologics to position itself in services for biologics.
The facility has four 500-L bioreactors. Bora gains the facility and technologies for cell-bank generation, cell-line development for protein drugs, upstream and downstream processes, and quality control capabilities.
Source: Bora Pharmaceuticals
Cytiva To Open Mfg Facility for Single-Use Kits For Cell Therapies
Cytiva plans to open a new manufacturing facility for single-use kits for cell therapies in Grens, Switzerland, later this month (May 31, 2022).
The 7 400-m² site will manufacture single-use kits for its Sepax and Sefia cell-processing systems, as well as consumables for its Xuri cell-expansion systems. It will also serve as a Center of Excellence for Cytiva’s cell-and gene-therapy business and will be a base for European customer training programs.
The facility will quadruple Cytiva’s capacity for manufacturing Sefia, Sepax, and Xuri consumable products with two new ISO class 7 cleanrooms. A R&D facility is located on the first floor, which consists of several laboratories designed for multidisciplinary engineering and cell biology processing capabilities. The customer training center, located on the second floor, will enable process and application training with Cytiva instruments, consumables, and software.
The existing site in Eysins, Switzerland will continue operations through 2023 while full production transfers to the new site in Grens.
Grifols Completes Acquisition of Biotest
Grifols, a Barcelona, Spain-based producer of plasma-derived medicines and a provider of technologies and services, has completed its acquisition of Biotest AG, a Dreieich, Germany-based healthcare company specialized in hematology and clinical immunology.
The acquisition of Biotest AG enables Grifols to expand its product portfolio in plasma therapies and plasma network. The company now has a European network of 87 plasma centers (29 Biotest and 58 Grifols) and fractionation capacity with more than 20 million liters of plasma annually.
Thermo Fisher, Charles River Join Robotic Cell-Therapy Mfg Consortium
Thermo Fisher Scientific and Charles River Laboratories have joined a robotic cell-therapy manufacturing consortium founded by Multiply Labs, a robotics technology company.
Multiply Labs created the consortium in 2021 with the goal to develop and validate a robotic manufacturing system that is capable of manufacturing gene-modified cell therapies at industrial scale. The consortium’s robotics development activities are coordinated by Multiply Labs while the cell-manufacturing process is overseen by the University of California San Francisco (UCSF) through a sponsored research agreement. Cytiva also had initial participation in the consortium.
Each consortium member contributes their own technology for cell-therapy manufacturing. Cytiva contributes automation of bioreactor technology, Thermo Fisher will contribute automation of incubator technology, and Charles River will contribute automation of quality control testing.
Source: Mulitply Labs
Formulation Development/Drug-Product Manufacturing
PCI Investing $100 M To Expand Fill–Finish, Lyophilization Capacity
PCI Pharma Services, a CDMO and contract provider of packaging services, is investing $100 million to expand its capabilities and capacity in aseptic liquid fill–finish and sterile lyophilization technology at its campus in Bedford, New Hampshire.
Following its acquisition of LSNE Contract Manufacturing, a CDMO of fill–finish and lyophilization services in December 2021, this expansion plan includes a 50,000-square-foot facility, which will allow PCI to expand its biologics packaging and specialty manufacturing within a multi-product facility. The building will include an aseptic fill–finish line with a fully isolated containment system and have twin lyophilizers with auto-loading and unloading systems, with the capacity to complete 400 vials per minute on a sterile fill–finish line.
Source: PCI Pharma Services
Kindeva Drug Delivery To Acquire iPharma Labs
Kindeva Drug Delivery, formerly 3M Drug Delivery Systems, has agreed to acquire iPharma Labs, a Union City, California-based inhalation contract development research organization (CDRO).
This acquisition will combine iPharma’s expertise in inhalation formulation and development of liquid, dry-powder, and propellant-based therapies with Kindeva’s expertise in developing, commercializing, and manufacturing inhaled therapies. The entire team at iPharma will join Kindeva at closing and will continue to operate from its existing location. The transaction is anticipated to close in the first half of 2022, subject to the satisfaction of customary closing conditions.
Source: Kindeva Drug Delivery
Ardena Expands Dry-Granulation, Spray-Drying Capabilities
Ardena, a Ghent, Belgium-based CDMO, has upgraded its development and manufacturing facilities in Pamplona, Spain, with investments in dry-granulation technology and upgrades to its spray-drying capabilities.
New roller compaction equipment enables Ardena to offer a dry-granulation service alongside its existing capabilities in wet granulation and direct compression/blending. In addition, Ardena’s existing spray-drying offering will be upgraded with ancillary equipment to allow the company to manufacture inhaled drugs.
Lonza Adds TiO2-Free Gelatin Capsules
Lonza has expanded its Capsugel offering with the addition of titanium dioxide-free (TiO2-free) white hard gelatin capsules. This opacifying technology uses the functionality of crystalized salts to provide the same whiteness and masking as capsules containing TiO2.
Lubrizol Life Science Health Launces New Excipient for Parenteral Drugs
Lubrizol Life Science Health, a CDMO and excipient manufacturer, has launched Apisolex, a solubility-enhancing excipient for use in parenteral drug products. The Apisolex excipient enables both the formulation of new chemical entities and the reformulation of existing APIs.
Source: Lubrizol Life Science Health
Coriolis Pharma Appoints New CEO
Coriolis Pharma, a Martinsried-Munich, Germany-based contract provider of formulation research and development and analytical testing, has appointed Silvia Steyrer-Gruber, previously Managing Director Europe at Exeltis (part of the Insud Pharma Group), as CEO.
In her previous role as Managing Director Europe at Exeltis, she was responsible for the European branded pharmaceutical business of Multinational Healthcare Group. Prior to that, she served at Baxter, Kwizda Pharma, and Serono in senior roles and gained more than 25 years of industry.
Source: Coriolis Pharma
Stevanato Group in Pact for Auto-Injector Platform
Stevanato Group, a provider of drug-containment, drug-delivery and diagnostic products and services, has signed an exclusive collaboration agreement with Owen Mumford, a medical device developer and manufacturer, for its Aidaptus auto-injector platform.
Aidaptus is a two-step, single-use auto-injector with a design that accommodates both 1-mL and 2.25-mL prefilled glass syringes in the same base device.
The agreement makes Stevanato Group an exclusive manufacturing partner for the device. Stevanato Group will mold the components for Aidaptusand provide final and sub-assembly equipment while also offering pre-filled syringes. Assembly of the components will be undertaken by both Stevanato Group at its global manufacturing sites and by Owen Mumford at its automated assembly center of excellence in the UK.
Source: Stevanato Group
Waters, University of Delaware Open Innovation, Research Lab
Waters Corporation and The University of Delaware have opened a new innovation and research laboratory.
Located at the University of Delaware’s Science, Technology and Advanced Research campus, the Immerse Delaware laboratory is a bioprocess laboratory focused on the entire manufacturing process from clone selection to quality control of drug substances.
As part of their multi-year research partnership announced in October 2021, the lab opening is the first step to collaborate with biopharma scientists both in industry and academia to advance industrial processes for making and characterizing biotherapeutics.
Source: Waters Corporation