AI
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.
About Benchling
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.
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MEDTECH, INDUSTRIAL IMPACT
ATUM and Codiak | January 25, 2023
On January 24, 2023, ATUM, a global leader in bioengineering solutions, announced that it has signed a comprehensive licensing agreement with Codiak BioSciences, a clinical-stage biopharmaceutical company, for the Leap-In Transposase® technology.
ATUM will grant Codiak access to its Leap-In Transposase® technology in order to create mammalian cells expressing exosomes engineered to deliver therapeutic payloads under the conditions of the agreement. The Leap-In technology is a comprehensive solution that integrates patented re-coding algorithms, unique genetic vector elements, and a transposon-based mechanism for efficiently inserting genetically stable elements into the genome.
"Through years of rigorous research and clinical validation we have created a platform for engineering and manufacturing therapeutic exosomes with various payloads on the surface or inside the lumen. We believe ATUM's transposase technology has the potential to effectively synergize with Codiak's engEx® Platform to further enhance loading these vesicles, making them more potent and reducing cost of goods," Commented Scott Estes, Ph.D., VP of Cell Line Development at Codiak.
(Source – Business Wire)
"Exosomes are bio vesicles that have the potential to fundamentally change drug delivery. We are proud and excited to license the Leap-In Transposase® technology to Codiak for the engineering of cell lines that enables rapid and robust production of exosomes," said Claes Gustafsson, Ph.D., Chief Commercial Officer and Co-Founder at ATUM.
(Source – Business Wire)
About Codiak
Founded in 2015, Codiak is a clinical-stage biopharmaceutical firm focused on developing exosome-based treatments, a new class of medications with the potential to change the treatment of a variety of diseases with high unmet medical needs. It created a proprietary engEx Platform that uses exosome biology as natural intercellular transfer mechanisms to design, construct, and manufacture innovative exosome therapeutic candidates. By utilizing its engEx Platform, it has produced a rich pipeline of engineered exosomes for neuro-oncology, oncology, neurology, neuromuscular, and infectious diseases.
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CELL AND GENE THERAPY, INDUSTRIAL IMPACT
Center for Breakthrough Medicines | February 27, 2023
Center for Breakthrough Medicines (CBM), a leading contract development and manufacturing organization dedicated to addressing the challenges of commercializing cell and gene therapies, and Virion Therapeutics, a clinical-stage biotech firm focused on developing accessible and adaptable CD8+ T cell-based technologies for cancer and infectious diseases, have recently announced a strategic collaboration agreement.
CBM will partner and manufacture with Virion Therapeutics on their checkpoint modifier clinical development programs, including the First-in-Human VRON-0200 immunotherapy, designed to treat chronic Hepatitis B Virus (HBV) infection.
The collaboration aims to develop VRON-0200, a pan-genotypic, global therapeutic immunotherapy that targets chronic HBV infection, which affects over 295 million people worldwide. HBV impairs CD8+ T cells, which results in the loss of viral control. VRON-0200 induces a broad CD8+ T cell response, which includes responses to the core and pol regions not generally induced by the infection. Therefore, VRON-0200 is designed to stimulate a highly functional immune response to help clear the virus.
CBM's Co-Founder and Chief Business Officer Audrey Greenberg commented, "Virion is working to revolutionize the immunotherapy treatment landscape, and we are honored to partner with them on this bold mission as we share a common goal – to create a future free of cancer and chronic infectious diseases." She further emphasized, "We have assembled best-in-field technical teams, supported by industry-leading product and process development, manufacturing, and testing capabilities, all located within a single, world-class manufacturing facility. We look forward to working with Virion to bring their life-saving therapies to the patients who need them most, as quickly as possible."
(Source – PR Newswire)
About Center for Breakthrough Medicines
The Center for Breakthrough Medicines is a pioneering contract development and manufacturing organization (CDMO) situated in the center of "Cellicon Valley," with a focus on cell and gene therapies. It offers an all-in-one solution to expedite the speed of delivering advanced treatments to the market. Its customer-oriented approach, combined with a culture that prioritizes the needs of patients, guarantees dependable and high-quality process and analytical development, GMP testing, viral vector manufacturing, plasmid production, cell therapy bioprocessing and cell banking services throughout the entire life cycle of a product.
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