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.
Benchling | January 27, 2023
On January 27, 2023, Benchling, the R&D cloud that powers the biotechnology sector, announced that it has passed the System and Organization Controls (SOC) 2 certification. Schellman, an independent Certified Public Accounting (CPA) firm, conducted the Type 2 SOC 2 test according to the AICPA's SOC 2 standards.
Type 2 SOC 2 evaluates the design and operational performance of an organization's security processes and controls to meet its security goals and customer commitments during a predetermined evaluation period. Constant monitoring, evaluation, and modification of the requirements and security measures guarantee a secure environment for doing business.
The CISO at Benchling, Zach Powers, said, "Biotechs are managing an evolving landscape of security and compliance risks, and they require trusted software partners to help them meet these demands." He added, "At Benchling, we make the security, privacy, and compliance of our customers' sensitive data a company-wide, critical investment, not only through Type 2 SOC 2, but also through our best-in-class security team, our trust-but-verify processes, and our adherence to global compliance standards."
(Source – PR Newswire)
Benchling's R&D Cloud is the biotech R&D platform of choice, trusted by over 1,000 organizations worldwide in highly regulated areas such as biopharmaceuticals, agribusiness, industrials, and consumer packaged goods. Benchling is used by customers to securely store, standardize, and analyze crucial data related to the design and development of innovative biotech products. Benchling's objective is to protect client data; hence, the firm utilizes sophisticated data security and privacy protections and complies with tight regulatory regulations such as the NIST Cybersecurity Framework. The organization is also ISO 27001 certified.
The successful completion of Benchling's Type 2 SOC 2 inspection assures that its biotech clients can conduct crucial R&D work in the Benchling R&D Cloud while following the highest security requirements.
Benchling is a San Francisco-based firm that focuses on private and public life science cooperation by developing cloud-based software tools for digital DNA sequence editing, planning and performing experiments, evaluating data, and sharing research. More than 200,000 scientists from over 1,000 firms and 7,500 university and research institutions worldwide have used the Benchling R&D Cloud to create breakthrough discoveries and deliver the next generation of medicines, foods, and materials to market more quickly. In addition, the R&D cloud assists these companies in modernizing their scientific processes and accelerating their cooperation to transform the complexity of biology into world-changing outcomes.
CELL AND GENE THERAPY, INDUSTRIAL IMPACT
ImmunoGen, Inc. | March 02, 2023
On March 1, 2023, ImmunoGen, Inc., a leading firm specializing in antibody-drug conjugates (ADCs), announced a global, multi-target license and option agreement with Vertex Pharmaceuticals. The deal provides Vertex with the rights to use ImmunoGen's ADC technology to research and discover targeted conditioning agents to be used in gene editing.
After each research period, Vertex will have the option to obtain an exclusive worldwide license to research, develop, and commercialize conditioning agents using ImmunoGen's technology for that target. ImmunoGen will hol full rights to the ADC technology for any targets not covered by the Vertex license.
Vertex will pay an upfront payment of $15 million as part of the agreement. In addition, ImmunoGen is eligible to receive up to $337 million in option exercise fees, development, and commercial milestone payments for each target. ImmunoGen will also receive tiered royalties as a percentage of worldwide commercial sales of licensed targeted conditioning agents by Vertex. Vertex will be responsible for all research, development, and commercialization costs.
ImmunoGen's Executive Vice President, Research, Development, and Medical Affairs, Michael Vasconcelles, MD, commented, "Given Vertex's extensive experience discovering and developing transformative medicines for patients with serious diseases, we are thrilled they have chosen to explore ImmunoGen's technology to develop ADCs for transplant conditioning in connection with gene editing." He further emphasized, "This agreement reflects our continued innovation in the ADC space and demonstrates the value of our technology platform and related intellectual property."
(Source – Business Wire)
About ImmunoGen, Inc.
ImmunoGen is dedicated to improving the lives of people with cancer by developing precise, targeted cancer therapies. Its lead product candidate is a first-in-class ADC called mirvetuximab soravtansine, which targets folate receptor alpha (FRα) and is being studied in multiple ovarian cancer trials. The company's second program, IMGN632, is a CD123-targeting ADC being studied for the treatment of BPDCN and AML. ImmunoGen is also developing two earlier-stage assets: IMGC936, an ADAM9-targeting ADC co-developed with MacroGenics, and IMGN151, a next-generation anti-folate receptor alpha ADC. The company aims to keep cancer from disrupting people's lives and get them back to living today, tomorrow, and beyond.