Manufacturing roundup: Bionova to expand manufacturing space; Estonian manufacturer gets €18M investment

2023-02-09

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CDMO Bionova Scientific will be looking to expand its footprint in California. Bionova Scientific announced that it has started the commissioning of a third facility in the city of Fremont, CA. The expansion to Bionova Scientific’s manufacturing space and capabilities is part of a wider move by the company to broaden its portfolio. The CDMO currently has two other facilities in Fremont that include its headquarters and GMP manufacturing site and a warehouse. The new facility will act as a replacement headquarters and house the administrative and biologics development teams. The other facility will be used solely for manufacturing, with the company moving sometime in the middle of this year. Dedicating the space to only manufacturing will quadruple the company’s production space. No financial details or size details were given about the new site. “Increasing our GMP manufacturing footprint in the West Warren facility will let us offer our clinical and commercial clients more manufacturing slots to meet their timelines,” said Darren Head, Bionova Scientific’s CEO in a release . The Estonian biotech Icosagen AS is getting a leg up from the European Investment Bank (EIB) to establish a new manufacturing facility. Icosagen AS, based in Tartu, Estonia, has netted €18 million ($19.2 million) in financing with the bank to boost its discovery, drug development and production services. The biotech plans to construct a 1,600 square meter (17,222 square foot) plant in Tartu, to be finished in September of this year. The plant is expected to become operational sometime in 2024. According to Icosagen, it will become a central place for its customers to have R&D and manufacturing services for mammalian drug candidates. “Developing novel technologies and workflows will help increase our competitiveness in providing contract research and development service to our clients in Europe and other regions of the world. The cGMP facility will provide further state-of-the-art training and employment opportunities for local and regional scientists and, at the same time, expand the capabilities and impact of the European biopharmaceutical drug production industry,” said Icosagen CEO Mart Ustav in a release emailed to Endpoints News. Genenta Science will be looking to ACG Biologics to help manufacture a cell therapy product for its clinical programs. According to a release, Genenta CEO Pierluigi Paracchi said the company is looking to scale up its manufacturing process to be ready for a Phase II trial, but no other details of the deal were released. “This investment in manufacturing represents a significant step forward based on our expectation that our treatment has the potential to impact the tumor micro-environment and break immune tolerance in solid tumors,” Paracchi said in a release. Genenta had an existing manufacturing agreement with Molecular Medicine as it was producing materials out of its factory in Milan, Italy which was acquired by ACG in 2020. The Milan site has been producing lentiviral vectors and products for Genenta since 2016. “This collaboration highlights the strength of AGC Biologics’ viral vector services, our scientific expertise and the decades of scientific GMP manufacturing knowledge we have here in Milan,” said Luca Alberici, General Manager, AGC Biologics Milan in the release . The manufacturing giant Thermo Fisher will be partnering up with the Boston-based biotech Elektrofi. Elektrofi, which focuses on drug formulation and delivery, will receive support for the production of its “ultra-high concentration subcutaneous products.” According to a release , Elektrofi plans to move forward with several clinical trials next year, and the deal with Thermo Fisher will allow the biotech to have a manufacturing line established. That line is expected to come online in early 2024 to support the clinical efforts and set up for future development. “We are eager to begin investigating our subcutaneous delivery technology in human clinical trials to explore how it can positively impact the healthcare space, both by easing the burden on patients and caregivers and by improving therapeutic outcomes,” said Elektrofi CEO Chase Coffman in the release. He continued: “To successfully initiate clinical development, we need to establish certified cGMP manufacturing capabilities.” Contract manufacturer GenScript ProBio will be partnering with the UK-based Bio Immunitas to develop therapies. The partnership will see GenScript ProBio providing CMC services for Bio Immunitas, which will aim to accelerate the biotech’s development of two recombinant protein products. However, no other details on the partnership were disclosed. “This relationship will help us realize our commitment to creating innovative, differentiated treatments for millions of patients,” said Bio Immunitas CEO and CMO Syed Haq in a release . The Pennsylvania CDMO Center for Breakthrough Medicine (CBM) has launched a plasmid offering, called Precision Plasmids, for customers in the cell and gene therapy space. In CBM’s announcement, it said it will offer plasmids for R&D, toxicology studies, Phase I and II vectors and material in mRNA. Only certain types of plasmids are immediately available with GMP-grade plasmids being available in April. “CBM’s Precision Plasmid solves the capacity challenge by bringing a platform process, multiple scales, and segregated suites to meet any clinical and commercial production needs on demand,” said Dana Cipriano, CBM’s SVP of Testing and Analytical Services & Plasmids in a release .