.jpg)
CELL AND GENE THERAPY, INDUSTRIAL IMPACT
GenScript ProBio | February 24, 2023
GenScript ProBio, a renowned Contract Development and Manufacturing Organization (CDMO), has recently entered a strategic partnership agreement with RVAC Medicines Pte. Ltd., a biotech company specializing in the development and commercialization of mRNA vaccines and therapeutics. The collaboration is aimed at manufacturing GMP-grade plasmid DNA (pDNA) for the RVM-V001 mRNA COVID-19 vaccine candidate, as well as supporting future therapeutic pipelines.
GenScript ProBio will offer GMP plasmid manufacturing service for RVAC Medicines' program, RVM-V001. By collaborating with GenScript ProBio, RVAC Medicines will be able to accelerate the clinical manufacturing of mRNA-based COVID-19 vaccines, as well as future mRNA-based vaccines designed to target other infectious diseases such as Clostriodioides difficile infection (CDI) and Respiratory syncytial virus (RSV).
As RVAC proceeds with the development of its mRNA candidates, GenScript ProBio continues to offer high-quality GMP materials crucial to the objective, including plasmid DNA and the development of ancillary materials to support mRNA manufacturing processes. GenScript ProBio also provides consultative and expert guidance regarding regulatory and quality expectations of agencies worldwide.
RVAC Medicines and GenScript ProBio will continue collaborating to support mRNA initiatives for both clinical and commercial stage development.
Dr. Brian Min, CEO of GenScript ProBio said, "We are delighted to enter into this strategic partnership with RVAC Medicines. This collaboration will enable us to utilize our cutting-edge GMP plasmid manufacturing platform technology to support the development of mRNA-based COVID-19 vaccine and its therapeutic candidates."
(Source – PR Newswire)
About GenScript ProBio
GenScript ProBio is a Contract Development and Manufacturing Organization (CDMO) that provides end-to-end drug discovery and commercialization services. The company's services are designed to accelerate drug development for its clients in various areas, including CGT, vaccines, biologics discovery, and antibody protein drugs. GenScript ProBio has a global presence, with subsidiaries in the Netherlands, the United States, South Korea, and China. Since October 2017, the company has helped clients in different regions, such as the United States, Europe, and Asia Pacific, to obtain over 40 IND approvals. Its goal is to drive innovation and speed up the biologics development process from target to market.
Read More
CELL AND GENE THERAPY, INDUSTRIAL IMPACT
The Center for Breakthrough Medicines | March 13, 2023
Nucleus Biologics and Stoic Bio have teamed up to form a supply agreement with the Center for Breakthrough Medicines (CBM), a contract development and manufacturing organization that aims to accelerate the development and manufacture of advanced therapies. Under the agreement, Nucleus Biologics will become CBM's selected supplier of cell culture media and other biological solutions, ensuring a consistent supply of this critical material with tighter quality control measures.
Nucleus Biologics' approach to cell culture media, which sees it as a critical raw material that can drive desired attributes of cells crucial to the success of cell and gene therapy research, is complementary to CBM's focus on transparency, technology, and end-to-end solutions. By working together, they hope to expedite cell and gene therapy breakthroughs.
In addition, CBM will be an early adopter of Stoic Bio's innovative family of point-of-use media makers, Krakatoa™, which allows scientists to manufacture their own media with 65% fewer CO2 emissions than conventional media. By demonstrating that developing and manufacturing lifesaving therapies doesn't have to come with a high environmental cost, CBM hopes to set an example for the industry.
With over 2,200 cell and gene therapies in development, collaborations like this one are needed to speed up the process of getting these therapies to the clinic and ultimately approved. The CBM, Stoic Bio and Nucleus Biologics collaboration aim to create a unique service offering that introduces a paradigm shift in development and manufacturing, showing how technology and sustainability can converge to make better therapies sustainably.
About The Center for Breakthrough Medicines
The Center for Breakthrough Medicines (CBM) is a CDMO focused on accelerating the development and manufacture of advanced therapies to save lives. It offers end-to-end solutions such as process development, manufacturing, and quality control for cell and gene therapies, gene editing, and immunotherapies. In addition, CBM collaborates with pharmaceutical companies, academic institutions, and healthcare providers to make advanced therapies more accessible while ensuring compliance with regulatory standards. The company also prioritizes sustainability by implementing green initiatives and sustainable technology and strives to positively impact the communities it operates in.
Read More
MEDTECH, INDUSTRIAL IMPACT
Atreca, Inc. | February 07, 2023
On February 6, 2023, Atreca, Inc. (Atreca), a biotechnology company that develops novel therapeutics through a deep understanding of the human immune response, with a focus on innovative novel cancer immunotherapeutics, and Xencor, Inc., a clinical-stage biopharmaceutical company that develops cytokines and engineered antibodies for the treatment of autoimmune diseases and cancer, announced, as part of their existing strategic collaboration, that they have mutually selected the first program combining an Atreca-discovered antibody with Xencor's XmAb® bispecific Fc domain and a cytotoxic T-cell binding domain (CD3).
The initiative announced is the first of up to two collaborative programs that can be selected by mutual agreement for future development and commercialization, with each partner sharing 50% of expenses and earnings. This program's clinical development, regulatory, and commercialization operations will be led by Atreca, while Xencor will lead the second prospective joint program. Furthermore, the agreement permits each partner to pursue up to two collaborative programs separately.
The unveiled joint program is based on APN-346958, an antibody discovered by Atreca. APN-346958 targets a new RNA-binding protein and is tumor-reactive in at least 50% of samples for six tumor types tested: thyroid, colorectal, head and neck, melanoma, urothelial, and brain cancer. In preclinical tests, the XmAb bispecific antibodies engineered against the target of APN-346958 displayed substantial anti-tumor activity. Atreca and Xencor hope to name a candidate from the program later this year, with Atreca aiming for an investigational new drug (IND) application in early 2025.
About Atreca
Founded in 2011, Atreca is a biopharmaceutical firm that employs its distinct discovery platform to create innovative antibody-based immunotherapeutics. Its Immune Repertoire CaptureTM (IRCTM) technology provides unmatched insight into how cancer patients' immune responses can lead to improved clinical outcomes offering access to an undiscovered terrain in oncology. Atreca was created by industry leaders, scientists, and investors who believe that unlocking today's patients' immune responses is the key to developing a new generation of therapies.
Read More