Cerbios, Olon, PCI Expand; Thermo Fisher, GE in Biomfg Pacts
The latest news from contract development and manufacturing organizations, contract manufacturing organizations, and other suppliers featuring news from Cerbios-Pharma, Olon, Hovione, Thermo Fisher, GE Healthcare Life Sciences, and PCI Pharma Services.
Chemicals/Chemical API Manufacturing
Cerbios-Pharma to Invest in High-Potency API Manufacturing
The Board of Director of Cerbios-Pharma, a Lugano, Switzerland-based contract development and manufacturing organization of both chemical and biological active pharmaceutical ingredients (APIs), has approved the detailed design and budget for the installation of a new production line in a building dedicated to high-potency active ingredients (HPAIs) manufacturing to enable accommodation of larger volumes and batch sizes.
The new production line will consist of six HPAI production units in a single site with space available for future expansions if needed. The new production line is designed to accommodate SafeBridge Category 3 for batches ranging from 5 kg to 30 kg. The new unit will be partially occupied for the manufacturing of an HPAI where larger volumes are required to decrease the production costs compared to the actual setup, according to the company. The remaining capacity will be available for Cerbios CDMO services and partners. Completion is expected in the second half of 2020.
Overall, the company has established expertise on handling up to SafeBridge Category 4 (occupational exposure limit of less than 10 ng/cubic meters) for drug substances in four different lines: two non cGMP and two cGMP.
In separate news, Francesca Scarpitta, PhD, has joined Cerbios as Director of the HPAPI production units. Since 2000, she has held various positions in research and development (R&D) and in operations in the API sector in Italy and in Israel, with over 10 years of experience in the manufacturing of HPAIs. Her prior roles at Teva were production manager of HPAI steroids and anticancer agents, where her responsibilities were with the Technology Transfer Unit for transferring new processes to production and Head of the HPAI Process Development Laboratory at Teva in the company’s Sicor Santhià plant. She also was a researcher at Nikem Research and at a Teva R&D lab, Prosintex ICI R&D Labs. She holds a PhD in organic chemistry from the University of Pavia in Italy.
Hovione Issues $50-Million Bond for Capital Expansion
Hovione, a contract development manufacturing organization (CDMO) of active pharmaceutical ingredients and drug products, has issued a bond of $50 million and with a maturity of 15 years (maturing in 2033) to fund future capital expansion.
“We issued this bond to strengthen our balance sheet as we embark in a new phase of significant capital expansion,” said António Almeida, Chief Financial Officer, Hovione in a January 25, 2019 company statement. The company said that it issued a US-dollar-denominated bond because the majority of its sales is in the US.
Olon Acquires Capua Bioservices
Olon, a Rodano (Milan), Italy-headquartered contract development and manufacturing organization of active pharmaceutical ingredients (APIs) and a generics supplier, has acquired Capua BioServices, a Capua, Italy-based provider of CDMO services for microbial fermentation.
Capua BioServices provides custom microbial process development and manufacturing for proteins, specialty small molecules, and microorganisms for applications in pharmaceutical, food, feed, and other bioindustrial markets.
With the acquisition, Olon gains a site in Capua, nearby Naples, Italy with a total fermentation capacity of about 1,400 cubic meters. Capua BioServices has approximately 200 employees. Olon says that no impact on jobs is planned and that it intends to invest in the site to optimize the plant’s utilization and expand the company’s customer base.
The move is part of a strategy by Olon to expand its global footprint, which includes a plan to add biologics-based manufacturing to add to its existing capabilities in small-molecule APIs and intermediates development and manufacturing.
Olon has been making moves in recent years to build its API operations. In 2016, the company acquired INFA Group, an API and fine-chemicals manufacturer headquartered in Milan, Italy. With the INFA acquisition, Olon gained two manufacturing sites in Italy (Labochim and Sifavitor) and one in Spain (Derivados QuÃmicos). In 2017, it acquired Ricerca Biosciences’ Chemical Division and separately invested more than EUR 10 million ($11.3 million) to expand API manufacturing lines in its Settimo Torinese, Italy facility, a plant used for development and production of APIs and advanced intermediates through microbial fermentation technology. In September 2018, it announced the acquisition of an API manufacturing facility in Mahad, India, a local generics chemical operations API manufacturing facility that supplies products to Sandoz, the generics arm of Novartis. That deal is expected to close in the first quarter of 2019.
GE Healthcare Life Sciences, G-Con Partner in Viral Product Mfg
GE Healthcare Life Sciences and G-CON Manufacturing, a College Station, Texas-based maker of prefabricated cleanroom PODs, have announced that they plan to collaborate to incorporate GE Healthcare’s modular, end-to-end cell therapy and viral vector technologies and process designs into G-CON’s proprietary cleanroom technology to provide a manufacturing platform for early-stage clinical or commercial production.
The collaboration will enable the companies to provide a fully functional production line and environment that can be housed in a warehouse-type structure. The collaboration will also include cleanroom technology required for the manufacture of lentivirus and adeno-associated virus vectors, a delivery vehicle for gene-therapy treatments.
Last year (2018), GE Healthcare launched FlexFactory for cell therapy, a semi-automated, modular end-to-end manufacturing platform. The collaboration strengthens this offering as the cell therapy FlexFactory can be installed into a cleanroom provided by G-CON. This offering is further supported by the vector G-CON POD.
Thermo Fisher, Torque Partner for Cell-Therapy Manufacturing
Thermo Fisher Scientific and Torque, a Cambridge, Massachusetts-based pharmaceutical company specializing in immuno-oncology, have formed a collaboration to build a dedicated Slipstream manufacturing facility for production of Torque’s T cell immunotherapies. Slipstream is a proprietary T cell manufacturing platform engineered by Torque.
Buildout of the Torque/Thermo Fisher manufacturing facility has begun, and the companies anticipate processing patient cells by the end of 2019. The Slipstream platform will initially be used in the clinical development of Torque’s lead Deep-Primed T cell candidate, TRQ-1501, in solid and hematologic tumors followed by TRQ-1201, also for solid and hematologic tumors.
The Slipstream platform technology situated in in Princeton, New Jersey uses a fully closed, semi-automated system in which production capacity can be expanded modularly by adding arrays in Lego-like fashion. The cell engineering process uses a modular design that enables both large-scale and decentralized manufacturing.
The platform will be used for Torque’s proprietary Deep-Primed T cell therapies, which both target multiple tumor antigens and pharmacologically activate an immune response with anchored cytokines. Torque says that this process does not require genetic engineering of the T cells and so preserves the natural T cell receptor for delivering a regulated immune response, with the potential for a high margin of safety. In addition to antigen priming, immunomodulators are tethered to the surface of Deep-Primed T cells—initially IL-15 and IL-12 cytokines, and TLR agonists—that activate both innate and adaptive immunity. The company says by loading precise doses of cytokines onto the surface of T cells, Deep Priming focuses the immune response to target the tumor, without systemic exposure.
Torque’s lead product candidate—TRQ1501 (Deep IL-15 primed T cells)—will initiate Phase I/II clinical trials for hematologic and solid tumors in the first quarter of 2019.
PCI Pharma Services To Expand Bottling Line Capacity
PCI Pharma Services, a provider of pharmaceutical packaging solutions and a contract development and manufacturing organization of drug products, is expanding bottling-line capacity at its commercial packaging site in Rockford, Illinois. Construction of the additional packaging suites began in March 2018 to add primary and secondary packaging operations equipped with high-speed tablet filling, cartoning, and in-line serialization and aggregation. The new expansion will increase capacity for its bottling operation in Rockford by an extra 100 million bottles per year.
The investment at its Rockford location is the latest in a series of capacity expansion initiatives by the company, including multiple facility enlargements, cold-chain and ultra-cold storage extension, installations of additional packaging lines and serialization solutions. The company also recently announced a $20-million investment in commercial packaging as well as expanded cold-chain capacity at numerous global locations.
Source: PCI Pharma Services