AGC Acquires Former AstraZeneca Facility; Cambrex CEO To RetireBy
The latest from CDMOs, CMOs, and suppliers featuring Flamma, AGC Biologics, Cambrex, Thermo Fisher, Corning, Evonik, Stevanato Group, and PCI Pharma Services.
Chemicals/Chemical API Manufacturing
Flamma Starts Construction for a New R&D Building in Italy
Flamma SpA, a CDMO for small-molecule active pharmaceutical ingredients (APIs), has started construction for a new R&D building at the company’s headquarters in Chignolo d’Isola, Bergamo, Italy.
The company says this expansion will quadruple its R&D space. The R&D building will accommodate 50 additional employees and additional R&D and analytical development laboratories as well as offices and meeting rooms. In addition to these features, there will be a lab for high containment and special chemistries.
The new R&D building in Italy will serve as a complement to the R&D work being done at Flamma USA in Malvern, Pennsylvania, located outside of Philadelphia.
Source: Flamma Group
AGC Biologics Acquires Former AstraZeneca Biomanufacturing Facility
AGC Biologics, a biologics CDMO, has purchased a commercial manufacturing facility, formerly owned by AstraZeneca, in Boulder, Colorado to provide it with additional capacity and larger-scale production. The facility is expected to begin full-scale operations and manufacturing by April 2021.
The Colorado facility is a large-scale biopharmaceutical manufacturing facility that houses two 20,000-liter (total volume) stainless-steel mammalian-cell bioreactors. The site also has more than 20 acres to allow for future expansions, including space for up to four more 20,000-liter bioreactors.
In addition to this facility acquisition, AGC Biologics is completing facility expansion projects in 2020 and early 2021 at its facilities in: Seattle; Copenhagen; and Chiba, Japan.
Source: AGC Biologics
Thermo Fisher, CSL Partner for Biomanufacturing; Thermo To Operate Swiss Site
Thermo Fisher Scientific and CSL Limited, a Melbourne, Australia-based biopharmaceutical company, have entered into a strategic development and manufacturing partnership.
Thermo Fisher will support CSL’s product portfolio by using its pharma services network, including drug-product development, biologics manufacturing, sterile fill–finish, packaging, and clinical trials logistics. Through a long-term lease agreement with CSL, Thermo Fisher will operate a biologics manufacturing facility in Lengnau, Switzerland, when construction is completed in mid-2021.
Within the Lengnau site, Thermo Fisher will support manufacturing of CSL’s product for hemophilia patients. The site will feature flexible bioproduction technologies, including single-use and stainless steel, to provide a pathway from development to large-scale production. Over time, Thermo Fisher says it plans to expand the use of the site to include additional biopharma customers.
Source: Thermo Fisher Scientific and CSL Behring
WuXi Advanced Therapies Names CEO
WuXi AppTec, a Shanghai, China-headquartered contract service provider, has appointed David Chang, PhD, as Chief Executive Officer of the business unit of its cell- and gene-therapy CDMO, WuXi Advanced Therapies.
In this role, Dr. Chang will provide strategic, scientific and operational leadership to the company’s cell and gene therapy R&D and manufacturing services.
Prior to joining WuXi AppTec, Dr. Chang was Corporate Vice President and Head of Cell Therapy Global Manufacturing at Celgene, now part of Bristol Myers Squibb, where he oversaw the CAR-T manufacturing network and the global manufacturing sciences and technologies teams. He also served as the Global Head of Engineering and Strategy at Roche, Switzerland, after roles that included Vice President/Site Head of Roche Shanghai Technical Operations, China.
Source: WuXi AppTec
Formulation Development/Drug-Product Manufacturing
Evonik Launches Custom Excipients for Parenteral Drugs
Evonik has launched custom functional polymeric excipients for controlled release of parenteral drugs, Resomer Precise
The Resomer Precise are custom excipients with product specifications as narrow as ± 0.02 dL/g for inherent viscosity, which is between four and 10 times more precise than standard industry polymers used with parenteral drug products, according to information from the company, and provide accuracy and precision for other key polymer quality attributes, including molecular weight and glycolate block length.They are suitable for use with more than 20 high- and low-molecular weight polymers for controlled-release formulations from Evonik’s Resomer portfolio, including PLA (poly (D,L-lactide) and PLGA (poly (D,L-lactide-co-glycolide).
Like with other Resomer and Resomer Select polymers, Evonik says it can supply Resomer Precise grades at lab, clinical or commercial volumes from its cGMP facilities in the US and Germany.
MedPharm Acquires New US Facility
MedPharm, a Guildford, UK-headquartered contract provider of formulation and development services for topical and transdermal products, has obtained a facility in Durham, North Carolina to expand its manufacturing capacity in the US to complement an existing manufacturing facility in the UK.
The Durham, North Carolina facility will house liquid and semi-solid manufacturing and packaging capabilities with an initial capacity of up to 250 kg. Located within a few miles of MedPharm’s current Center of Excellence in Research Triangle Park, North Carolina, the facility is expected to complete initial qualification by the start of the fourth quarter in 2020.
The new site provides MedPharm’s US-based clients the opportunity to manufacture clinical batches and early-stage development scale domestically.
Corning, Pfizer Sign Long-Term Pact for Glass Vial Supply
Corning, a material sciences company, and Pfizer have announced the execution of a long-term purchase and supply agreement for Corning Valor Glass, an alkali aluminosilicate-based product for parenteral drug packaging.
The multiyear agreement provides for the supply of Valor Glass vials to a portion of currently marketed Pfizer drug products, pending regulatory approval.
Corning partnered with Pfizer and Merck & Co. to develop the new glass vials to improve chemical durability and to resist breakage, damage, and particulate contamination. Pfizer and Merck provided insights on pharmaceutical formulation and manufacturing processes to aid in product development and for initial testing of the product. Corning announced in 2017 an initial investment of $500 million as part of a planned total investment of $4 billion, which included a new a pharmaceutical glass packaging manufacturing facility in Durham County, North Carolina to support production of Corning Valor Glass
Since first launching its collaboration with Corning, Pfizer has continued to evaluate Valor Glass’ performance across several aseptic sites, using multiple vial sizes in a range of drug products from Pfizer’s sterile injectables portfolio. During this time, Valor Glass was accepted into and provisionally evaluated under the US Food and Drug Administration’s (FDA) Emerging Technology Program, which was created to help promote the adoption of innovative approaches to pharmaceutical product design and manufacturing and allows private companies the opportunity to discuss, identify, and resolve potential technical and regulatory issues regarding the development and implementation of a novel technology prior to filing a regulatory submission.
Stevanato Group To Open Drug Development Center in US
Stevanato Group, a producer of glass parenteral packaging, headquartered in Padua, Italy, is preparing to open a Technology Excellence Center in Boston (US TEC), in Boston, Massachusetts, which is set to open in late September 2020.
Using the company’s knowledge in material science of glass, plastics, and rubber, US TEC will support biopharma companies in how to select the optimum glass container. The technology and knowledge transfer from the company’s Italian laboratory will be finalized in the fall (fall 2020).
Source: Stevanato Group
Comar To Build New Facility for Injection Molding and Assembly
Comar, a specialty packaging, device and component supplier, is building a new offsite location in Vineland, New Jersey, to expand plant operations of its Buena, New Jersey site.
The 159,000-square-foot Vineland facility will provide additional capacity for injection molding, assembly and finishing operations and increase warehouse and storage space. The facility will be ISO 13485-certified, cGMP compliant and FDA registered. The expansion, which is scheduled to be completed by March 2021, will also enable the company to refresh its Buena facility and increase capacity.
Cambrex CEO To Retire
Cambrex, a CMO of small-molecule active pharmaceutical ingredients and drug products, has announced that Steven Klosk, Chief Executive Officer (CEO), will retire as CEO and member of the Board of Directors on June 30, 2020, after 28 years with the company.
The company’s Board is currently is in the advanced stages of a search for Klosk’s successor. In the interim, the company will be led by an Office of the CEO comprised of Wayne Hewett, Chairman of the Board, Robert Green, Executive Vice President and Chief Financial Officer, and Samantha Hanley, Senior Vice President and General Counsel.
In addition, Shawn Cavanagh will step down as President, Chief Operating Officer, and member of the Board of Directors, to take on the new role of strategic advisor to the incoming CEO and Board of Directors for an initial twelve-month period.
PCI Pharma Services in Pact for Mfg, Pkg, Supply-Chain Services
PCI Pharma Services, a CDMO and packager, and Experic, a CMO and pharmaceutical supply service company, have entered into a strategic partnership for clinical and commercial manufacturing, packaging and supply-chain services.
The agreement will give Experic access to PCI’s clinical and commercial supply-chain capabilities and presence in Europe. In turn, Experic will provide PCI access to advanced powder-filling equipment and capabilities, including low-dose filling for inhalation and other delivery modalities.
Under the reciprocal agreement, Experic will have access to PCI’s integrated full services in the European Union, including the PCI European quality-control team to provide its clients access to manufacturing, packaging, storage, and delivery services that facilitate clinical trials in the region.
For PCI, Experic provides manufacturing technologies and filling equipment for micro-dosing through its partnership with Harro Höfliger, an Allmersbach, Germany-based production and packaging company. Experic’s low-dose powder-filling capabilities will also enable the transition of products from clinical to commercial-scale manufacturing.
Source: PCI Pharma Services