Expansions: Catalent To Invest $130 M; MilliporeSigma To Invest $65 MBy
The latest from CDMOs, CMOs, and suppliers featuring Catalent, MilliporeSigma, Evonik, Sharp, Asymchem, Vibalogics, and Thermo Fisher Scientific.
Chemicals/Chemical API Manufacturing
MilliporeSigma To Invest $65 M for HPAPI and ADC Mfg Expansion
MilliporeSigma has announced a EUR 59-million ($65-million) expansion of its high-potency API and antibody drug-conjugate (ADC) manufacturing capabilities and capacity at its facility near Madison, Wisconsin that will allow for large-scale manufacturing of potent compounds.
The new 70,000-square-foot commercial building will be designed to handle single-digit nanogram occupational exposure limit materials. The facility will incorporate containment areas to produce linker and payload materials for ADCs. The expansion is expected to be completed by mid-2022 and should add approximately 50 full-time jobs starting in 2021.
The facility will join the company’s facility in St. Louis, Missouri, which specializes in ADC bio-conjugation, APIs, excipients, and adjuvants manufacturing.
Asymchem Invests in Flow Chemistry Provider Snapdragon Chemistry
Asymchem, a Morrisville, North Carolina-based CDMO, has announced an investment in Snapdragon Chemistry, a Waltham, Massachusetts-headquartered provider of flow-chemistry process design and technology development services, to provide funding to Snapdragon for it to complete its expansion plan to build cGMP drug-substance manufacturing suites. Asymchem led the investment round along with the participation from Snapdragon’s previous investors.
Source: Asymchem and Snapdragon Chemistry
Catalent To Invest $130 M to Expand Gene-Therapy Mfg Capacity
Catalent has announced that it is investing $130 million to add five additional Phase III through commercial-scale manufacturing suites to its gene-therapy campus in Harmans, Maryland.
The Catalent Gene Therapy campus in Harmans consists of two facilities that, when completed, will house a total of 15 gene-therapy suites each designed to accommodate multiple bioreactors for commercial supply. The first facility on the campus was recently approved by the US Food and Drug Administration for commercial manufacturing and is expected to have all 10 cGMP suites qualified and operational by the first quarter of 2021. The five new cGMP suites will be located in an adjacent building on the Harmans campus and are anticipated to be operational in the first half of 2022. The second Harmans building will also offer cold-storage warehousing and additional office space.
The campus is one of Catalent’s five gene-therapy locations in Maryland and houses multiple cGMP manufacturing suites with pre-seed, bioreactor, and downstream rooms, together with fill/finish, testing, warehousing, supply chain, and central services capabilities. The facilities were gained as part of Catalent’s $1.2-billion acquisition in 2019 of Paragon Bioservices, a contract provider of viral vector development and manufacturing services for gene therapies.
Thermo Fisher Scientific Opens New Bioprocessing Collaboration Center
Thermo Fisher Scientific has opened a new Bioprocessing Collaboration Center (BCC) in St. Louis, Missouri. The facility is adjacent to the company’s biologics manufacturing facility, which recently doubled production capacity with a $50-million expansion.
Source: Thermo Fisher Scientific
Vibalogics Names Ex-Lonza Executive as New CEO
Vibalogics, a CDMO of therapeutic and prophylactic vaccines and biological products, has appointed Tom Hochuli as Chief Executive Officer (CEO).
He has more than 25 years of industry experience and was previously head of cell and gene therapy operations for Lonza Houston. He will be responsible for accelerating Vibalogics’ US expansion plans and global growth trajectory as the company sets on developing a late-phase and commercial virus manufacturing facility on the East Coast in the US.
Vibalogics specializes in the manufacturing of oncolytic viruses, viral vector vaccines, and viral vectors. It provides process development, manufacturing, testing and fill–finish services for early phase clinical trials from its 50,000-square-foot facility in Cuxhaven, Germany. The company was recently selected by Johnson & Johnson’s (J&J) Janssen as one of its manufacturing partners for J&J’s investigational COVID-19 vaccine candidate.
Formulation Development/Drug-Product Manufacturing
Evonik Qualifies Advanced Aseptic Filling Line in Alabama Facility
Evonik has announced the qualification of an advanced aseptic filling line for complex parenteral drug products at its Birmingham, Alabama facility.
The VarioSys line, which was designed by Bausch+Ströbel, can aseptically fill powder, liquid, suspension, or combination forms into vials for clinical or commercial batch sizes. The line is suitable for highly potent, personalized, or sensitive drug products as well as for some specialized vaccines, which are often designed for systemic or localized delivery of small molecules, peptides, proteins, and nucleic acids.
Sharp Launches Inventory Management System for Clinical Trial Material Supply
Sharp, part of UDG Healthcare and a provider of contract packaging and clinical supply services, has launched a new inventory management system to support clinical trial sponsors in managing inventory and supplies.
Sharp says the new system, named Clinventory, has been designed to provide full visibility of stock levels at investigator sites and tracking product through the supply chain.
Key features include: (1) on-demand study supply information; (2) elimination of the need for manual processes for dispatches and returns; (3) customizable automatic resupply, which can be updated as study enrollment increases or decreases; (4) temperature-excursion tracking with supply release and approval; and (5) manual shipment requests for emergency situations.
Source: Sharp Services
FDA OKs Thermo Fisher’s Companion Diagnostic for RET Mutations
The US Food and Drug Administration (FDA) has granted premarket approval to Thermo Fisher Scientific’s Oncomine Dx Target Test as a companion diagnostic (CDx) to identify RET (rearranged during transfection) fusion-positive, metastatic non-small cell lung cancer (NSCLC) patients who are candidates for Gavreto (pralsetinib), a targeted therapy developed by Blueprint Medicines.
The Oncomine Dx Target Test was initially approved in 2017 as a CDx for biomarkers associated with three FDA-approved NSCLC therapies. It is now approved for a targeted treatment for RET fusion-positive NSCLC. The test has also been approved by Japan’s Ministry of Health, Labour and Welfare (MHLW) as a CDx for four biomarkers, EGFR, ALK, ROS1, and BRAF, associated with 12 targeted therapies for NSCLC. Thermo Fisher says it will update the Oncomine Dx Target Test to enable it to report RET fusions in the US before the end of 2020. The diagnostic simultaneously evaluates 23 genes clinically associated with NSCLC.
Gavreto is a once-daily oral therapy designed to target RET fusions and mutations. Gavreto was granted accelerated approval by the FDA earlier this month (September 2020) for the treatment of adult patients with metastatic RET fusion-positive NSCLC.
In addition, Japan’s MHLW recently approved the test to assess patients who may be eligible for treatment with Rozlytrek (entrectinib) following a CDx agreement Thermo Fisher signed earlier this year with Chugai Pharmaceutical, a member of the Roche Group. The Oncomine Dx Target Test is currently approved and reimbursed by government and commercial insurers in the US, Europe, Japan, South Korea and Israel.
Source: Thermo Fisher Scientific