Our teams of cell therapy and gene therapy experts have deep scientific and technical experience across quality, regulatory, supply chain logistics, manufacturing, and R&D, and will put this expertise at your fingertips to rapidly deliver life-saving treatments to the patients who need them.
Integrated Enabling Services at Every Stage of Development
Discover CBM capabilities
Quality & Regulatory Services
As advanced therapeutics grow in sophistication, navigating the increasingly complex regulatory landscape can sometimes hinder the speed at which cell and gene therapies advance towards commercialization. CBM provides comprehensive quality and regulatory support to ensure high levels of compliance, control, and oversight for client programs throughout the entire advanced therapies project lifecycle. Our regulatory experts ensure adherence with FDA guidelines and interface directly with both our internal program team and your own team at every stage of development to collaboratively design strategies and processes that ensure compliance the first time, every time.
Tailored Quality & Regulatory Support
We have established a globally compliant and automated quality management system that provides phase-appropriate compliance to the clinical trial, while always ensuring the highest level of compliance needs as the program transitions to commercialization.
Change Management
Process & Production Control
Product Surveillance
Research & Development Services
The state-of-the-art R&D technology platforms at CBM’s fully integrated site have been developed by experts with proven track records commercializing cell and gene therapies to deliver unparalleled risk mitigation and a shorter route to market for your cell therapy or AAV gene therapy. We offer a wide range of R&D services at a single site – including cell line engineering, plasmid sequencing, vector engineering, and platform development – all of which are designed to accelerate your program by optimizing processes and assessing your project’s eventual manufacturability from the start.
On-Site R&D Platforms
Our R&D programs are piloted by industry veterans with demonstrated success in bringing advanced therapies through to commercialization. We leverage partnerships with industry pioneers to mitigate risk and deliver the fastest path to market.
Cell Line & Vector Engineering
Plasmid Sequencing Verification
Platform Development
Cell Banking Services
High-quality, uniform cell and viral banks are paramount to the successful development of cell and gene therapies. Our cell banking services are fully integrated with characterization release testing and stability studies to streamline workflows and accelerate your project’s speed to commercialization. CBM can collaborate with your team to manufacture GMP Master Cell Banks (MCB), Working Cell Banks (WCB), Master Viral Banks (MVB), and Working Viral Banks (WVB) that guarantee a robust, stable supply of starting materials throughout your project’s lifecycle.
Robust Cell & Viral Banks
We offer both cell and viral banking as a standalone service or in conjunction with manufacturing to ensure your project’s security by cultivating a robust supply of starting materials throughout its entire lifecycle.
Mammalian, Viral & Microbial
Master & Working Banks
Viral Seed Stocks
- Quality & Regulatory Services
-
Quality & Regulatory Services
As advanced therapeutics grow in sophistication, navigating the increasingly complex regulatory landscape can sometimes hinder the speed at which cell and gene therapies advance towards commercialization. CBM provides comprehensive quality and regulatory support to ensure high levels of compliance, control, and oversight for client programs throughout the entire advanced therapies project lifecycle. Our regulatory experts ensure adherence with FDA guidelines and interface directly with both our internal program team and your own team at every stage of development to collaboratively design strategies and processes that ensure compliance the first time, every time.
Tailored Quality & Regulatory Support
We have established a globally compliant and automated quality management system that provides phase-appropriate compliance to the clinical trial, while always ensuring the highest level of compliance needs as the program transitions to commercialization.
Change Management
Process & Production Control
Product Surveillance
- Research & Development Services
-
Research & Development Services
The state-of-the-art R&D technology platforms at CBM’s fully integrated site have been developed by experts with proven track records commercializing cell and gene therapies to deliver unparalleled risk mitigation and a shorter route to market for your cell therapy or AAV gene therapy. We offer a wide range of R&D services at a single site – including cell line engineering, plasmid sequencing, vector engineering, and platform development – all of which are designed to accelerate your program by optimizing processes and assessing your project’s eventual manufacturability from the start.
On-Site R&D Platforms
Our R&D programs are piloted by industry veterans with demonstrated success in bringing advanced therapies through to commercialization. We leverage partnerships with industry pioneers to mitigate risk and deliver the fastest path to market.
Cell Line & Vector Engineering
Plasmid Sequencing Verification
Platform Development
- Cell Banking Services
-
Cell Banking Services
High-quality, uniform cell and viral banks are paramount to the successful development of cell and gene therapies. Our cell banking services are fully integrated with characterization release testing and stability studies to streamline workflows and accelerate your project’s speed to commercialization. CBM can collaborate with your team to manufacture GMP Master Cell Banks (MCB), Working Cell Banks (WCB), Master Viral Banks (MVB), and Working Viral Banks (WVB) that guarantee a robust, stable supply of starting materials throughout your project’s lifecycle.
Robust Cell & Viral Banks
We offer both cell and viral banking as a standalone service or in conjunction with manufacturing to ensure your project’s security by cultivating a robust supply of starting materials throughout its entire lifecycle.
Mammalian, Viral & Microbial
Master & Working Banks
Viral Seed Stocks
Committed to Saving Lives Together
Transform Your Clinical Development.
Reimagine clinical development by intelligently connecting data, technology, and analytics to optimize your trials. The results? Faster decision making and reduced risk so you can deliver life-changing therapies faster.
Breakthrough Insights
Center for Breakthrough Medicines Launches Genesis Vector Manufacturing Solutions™ with New State-of-the-Art Vector Suites to Accelerate the Commercialization of Advanced Therapies
Accelerating AAV Analytical Development And Testing With Advanced Methods And Comprehensive Solutions
Frequently Asked Questions (FAQs) about Cell and Gene Therapy Products and Services
Click any question to view the answer
Much of the work being done in the cell and gene therapy field is novel, so the process of navigating the regulatory landscape and receiving regulatory approval for advanced therapies is considerably more ambiguous than for other modalities, such as biologics. While some aspects of development, manufacturing, and testing are better understood than others and are beginning to approach regulatory standardization, others such as potency assays, CMC during manufacturing are still common drivers of clinical holds. CBM leverages extensive expertise in manufacturing and process development, and experience interfacing with and preparing submissions for global regulatory bodies to ensure our customers’ projects rapidly reach clinical and commercial milestones while remaining compliant.
CBM provides a variety of research and development services as a part of our end-to-end offering. Investing in early-stage R&D can keep your program on track and help ensure the success and eventual commercialization of your cell or gene therapy. We offer cell line engineering, plasmid sequencing verification, vector engineering, and platform development services.
Plasmid DNA is produced using E. coli fermentation methods in large stainless steel bioreactors. The process is inherently slow and expensive, with limited capacity, and is prone to batch failure. Plasmid DNA is a critical starting material in the production of many advanced therapy products, including viral vectors, RNA vaccines, and cell and gene therapy research at any scale. To save time and accelerate your cell and gene therapy programs, we also offer off-the-shelf, pre-manufactured, GMP-ready viral vector packaging plasmids.