Seqens To Expand Flow-Chemistry Capabilities; Adare Acquires Orbis Biosciences
The latest news from CDMOs, CMOs, and suppliers featuring Seqens, Adare Pharmaceuticals, AGC Biologics, Avid Bioservices, Avantor, Kindeva, and Univercells.
Chemicals/Chemical API Manufacturing
Seqens To Expand Flow-Chemistry Capabilities
Seqens is adding additional capabilities in flow chemistry. The company carries out flow-chemistry development in the company’s R&D center, Seqens Lab, in Porcheville, France, which is equipped with continuous bench reactors and analytical tools for appropriate data acquisition. The company reports that Seqens Lab will be equipped at the end of 2020 with a new GMP pilot plant, capable of hosting nitration, diazotation or halogenation-type reactions, and of producing representative pre-commercial batches up to the ton scale.
Flow-chemistry processes combine expertise in chemistry and process engineering. The complementarity of these two disciplines is needed to industrialize, in a continuous mode, a process developed in the laboratory. Seqens has established experience in this area, including for continuous processes for intermediates and active pharmaceutical ingredients, such as GMP-grade salicylic acid.
Source: Seqens
Biologics Manufacturing
AGC Biologics, Faron Pharmaceutical in Mfg Pact
AGC Biologics, a CDMO for protein-based therapeutics, has been selected to commercially manufacture Clevegen, a humanized anti-Clever-1 antibody, for Faron Pharmaceuticals, a Turku, Finland-based biopharmaceutical company.
Clevegen is a precision immunotherapy and anti-Clever-1 antibody with the ability to switch immune suppression to immune activation in various conditions with potential across oncology, infectious disease, and vaccine development. Currently in Phase I/II clinical development as a macrophage checkpoint immunotherapy for patients with untreatable solid tumors, Clevegen has potential as a single-agent therapy or in combination with other standard treatments, including immune checkpoint molecules, according to information from the companies.
Clevegen targets CLEVER-1 positive-tumor-associated macrophages and converts these immunosuppressive M2 macrophages to immune-stimulating M1 macrophages. This macrophage-directed immuno-oncology switch may be used alone or in combination with other cancer treatments.
Source: AGC Biologics and Faron Pharmaceuticals
Avid Bioservices, Aragen Partner for Biologics Services
Avid Bioservices, a contract biologics manufacturer, and Aragen Bioscience, contract research organization focused on preclinical biologics product development, have entered into a co-marketing agreement to provide clients an integrated “sequence-to-manufacturing” service.
Under terms of the non-exclusive agreement, the companies will offer customers Aragen’s cell-line development services integrated with Avid’s upstream and downstream process development and analytical services for delivering cGMP bulk drug substances.
Source: Avid Bioservices and Aragen Bioscience
Avantor Launches Single-Use Sampling Solution for Bioprocessing
Avantor, a supplier of ultra-high-purity materials for the life sciences and advanced technology industries, has launched its new OmniTop Sample Tubes Adjustable Volume Sampling System (AVSS), which is designed to lower contamination risk and reduce volume loss by enabling technicians to collect an exact amount of media needed to perform routine sampling in bioprocessing operations.
The company says the OmniTop Sampling System is designed for high-integrity product sampling applications, such as with monoclonal antibodies and cell- and gene-therapy processes, as well as final fill operations.
Source: Avantor
Univercells Launches Subsidiary for Cell and Gene Therapies
Univercells, a technology company specializing in bioprocessing, has launched Univercells Technologies, a new subsidiary and brand of the company focused on the development and commercialization of intensified, automated biomanufacturing technologies for the cell- and gene-therapy market.
The new subsidiary will apply Univercells’ proprietary scale-X bioreactor portfolio, which provides upstream processing of viral products, and its NevoLine biomanufacturing platform for viral products, such as viral vaccines, gene therapies, and oncolytic viruses.
Source: Univercells
BioCentriq is New Name for NJIT’s Cell and Gene Therapy Center
The Biopharma Division of the New Jersey Innovation Institute and part of the New Jersey Institute of Technology (NJIT), located in Newark, New Jersey, has introduced BioCentriq as the name of its cell- and gene-therapy production and manufacturing center.
The GMP facility is located at NJIT’s Life Sciences and Engineering Center and features two GMP suites. The GMP suites are expected to complete their qualification and validation and be operational this summer (summer of 2020).
BioCentriq also offers a process development center, currently located at the Rutgers Medical School in Newark, New Jersey, which has been open and actively supporting projects since late 2019.
Source: New Jersey Innovation Institute
Formulation Development/Drug-Product Manufacturing
Kindeva, Formerly 3M Drug Delivery, Launches as a Separate Company
Kindeva Drug Delivery, formerly 3M Drug Delivery Systems, has launched as an independent company following the $650-million acquisition of 3M Drug Delivery Systems by Altaris Capital Partners, an investment firm.
With approximately 900 employees, Kindeva is a CDMO specializing in formulation development, product development, drug-delivery technologies, and manufacturing.
Kindeva has cGMP manufacturing operations in the following locations (Loughborough, UK; Clitheroe, UK; Northridge, California; and St. Paul, Minnesota) with R&D laboratories in Loughborough and St. Paul.
As part of the transaction, 3M will retain a 17% minority interest in Kindeva alongside Altaris.
Source: Altaris Capital Partners and Kindeva Drug Delivery
Adare Pharmaceuticals Acquires Orbis Biosciences
Adare Pharmaceuticals, a clinical-stage pharmaceutical company and a provider of pharmaceutical technologies, and a CDMO, has acquired Orbis Biosciences, a Lenexa, Kansas-based pharmaceutical technology company.
The acquisition was finalized on April 30, 2020 for an undisclosed amount. Orbis Biosciences will maintain its operations in Lenexa, Kansas and integration of the companies is underway (as reported on May 4, 2020).
Orbis provides technologies in a scaled, single-step manufacturing process. Its Precision Particle Fabrication technology is used to produce uniform particles in a size ranges suitable for use in injectable, otic, and oral dosage forms. The platform technology is customizable to accommodate a range of active ingredients, including small molecules, peptides, and proteins. Orbis’s proprietary technology includes three platforms: Optimμm for oral delivery; Stratμm for injectable delivery; and Unisun for otic delivery.
Source: Adare Pharmaceuticals
