From DCAT Week 2023: Supplier News: Biologics Manufacturing
A roundup of news from CDMOs/CMOs and suppliers in biomanufacturing, including advanced therapies, with news from BioVectra, Scorpius BioManufacturing, Avid Bioservices, IDT Biologika, Landmark Bio, and Mabion. Highlights below.
* BioVectra Expands pDNA, mRNA and Biomanufacturing Capacity in $80-M Investment
* Scorpius BioManufacturing Adding New Biomanufacturing Facility
* Avid Bioservices Expanding Biomanufacturing, Cell-, Gene-Therapy Mfg
* IDT Biologika Expanding Cell- and Gene-Therapy Mfg
* Landmark Bio Completes Construction of Advanced Therapies Mfg Facility
* Mabion Expanding Upstream, Downstream Bioprocessing
BioVectra Expands pDNA, mRNA and Biomanufacturing Capacity in $80-M Investment
BioVectra, a Charlottetown, Prince Edward Island, Canada-based CDMO of small-molecule active pharmaceutical ingredients and biologics, has provided an update of a $79.6-millioninvestment for the production and manufacturing of mRNA vaccines and therapeutics. Construction of a new facility began in April 2022 with completion slated for 2023. Other expansion activities include: (1) a new process development lab for plasmid DNA (pDNA) and mRNA opening in Nova Scotia (opening in June 2023); (2) scale-up of existing biologics process development and analytical labs in Prince Edward Island to support the company’s biomanufacturing center (opened in January 2023); and a single-use clinical scale microbial suite (100-1,000 liters) at the company’s biologics facility in Nova Scotia (completed in January 2023).
The company has also launched a new operations team to support these efforts. Bryan Lowery, Vice President and General Manager, mRNA Vaccine and pDNA Operations, is bringing the manufacturing team onboard,and Normand Blais, formerly in leadership roles in the Vaccines Division at GlaxoSmithKline, was recently appointed as Senior Director, Development and Innovation, to shape and lead the development of the company’s science program in mRNA and pDNA.
Scorpius BioManufacturing Adding New Biomanufacturing Facility
Scorpius BioManufacturing, a CDMO of biologics and advanced therapies. is expanding manufacturing capacity with the addition of a new 6,000-square-foot facility for mammalian cell culture and harvest, downstream purification processes, formulation, and fill–finish operations. Based in San Antonio, Texas, on the same campus as its 2,000-square-foot microbial facility, the mammalian facility is scheduled to be fully operational for cGMP production early in the second quarter of 2023. The expansion includes capabilities for up to the 1,000-L scale for mammalian and cell-therapy based products.
In addition, Scorpius announced the addition of Gary Welch to the company’s leadership team. As interim president, Welch brings more than 30 years of experience as a bioprocess operations leader, with extensive knowledge in cell-line development, process development, analytical and formulation development, manufacturing, and engineering.
Source: Scorpius BioManufacturing
Avid Bioservices Expanding Biomanufacturing, Cell-, Gene-Therapy Mfg
Avid Bioservices, a Tustin, California-headquartered CDMO of biologics and advanced therapies, has undertaken several facility expansions to increase capacity. The company recently completed its mammalian-cell facilities expansion. The company’s expansion adds approximately 42,000 square feet with 13,800-L single-use bioreactor capacity and new process development (PD) capabilities, which doubles its PD capacity. The company also continues to make progress on its new purpose-built cell- and gene-therapy facility, which will support early-stage development through commercial manufacturing. Process and analytical development capacity at this facility has come on line, and cGMP manufacturing suites are expected to go live by the end of 2023.
Source: Avid Bioservices
IDT Biologika Expanding Cell- and Gene-Therapy Mfg
IDT Biologika, a CDMO of biologics, vaccines, and cell and gene therapies, is expanding its cell-and gene-therapy capabilities with an investment of approximately EUR 30 million ($33 million) by 2026. The company is expanding its R&D and clinical-trial-materials capabilities at its site in Dessau, Germany, and is upgrading its US site in Rockville, Maryland.
Source: IDT Biologika
Landmark Bio Completes Construction of Advanced Therapy Mfg Facility
Landmark Bio, a Watertown, Massachusetts-based CDMO of biologics, has successfully completed construction of its advanced therapies development and manufacturing facility in Watertown. The facility supports development and cGMP manufacturing of cell therapies, gene therapies, viral vectors, RNA therapies, and non-viral gene delivery methods (e.g., lipid nanoparticles and extracellular vesicles). Launched in 2021, the company’s founding partners include Harvard University, the Massachusetts Institute of Technology, Cytiva, Fujifilm, and Alexandria Real Estate Equities.
Source: Landmark Bio
Mabion Expanding Upstream, Downstream Bioprocessing
Mabion, a Konstantynów Łódzki, Poland-based CDMO of biologics, is initiating an expansion and modernization of its GLP- and GMP-certified-site, which is due for completion in the first half of 2023. In 2021, upon signing a commercial-scale CDMO contract with Novavax, a Gaithersburg, Maryland vaccine maker for the production of Novavax’s antigen for its COVID vaccine, Mabion’s strategy has shifted toward becoming an end-to-end biologics CDMO, focusing on mammalian cell cultures in monoclonal antibodies with the aim to introduce new modalities, such as antibody drug conjugates and bispecific monoclonal antibodies in the mid-term.
A new 15-million debt facility secured from the European Bank for Reconstruction and Development in the first quarter of 2023 will finance new upstream equipment, which will double the company’s current capacity with four new bioreactors with a total volume of 10.000 liters further includes investments in downstream and new fill–finish lines.