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Cell & Gene Therapy

    DELIVERING THE NEXT GENERATION OF MEDICINE

    CRB’s ATMP thought leaders are a team of multidisciplinary subject matter experts guiding the future of the industry. We deliver value through our ability to design and construct a multiprocess facility predicated on maximum flexibility, logistics optimization and enabling technologies that will reduce overhead costs, allow pipeline expandability and produce a higher quality therapeutic.

    Market-defining Experience

    As interest in the ATMP market continues to grow at a rapid pace, novel processes are demanding facility and technology infrastructures unlike any that have previously existed. In this new era of medicine, risk mitigation begins with facility and process design and must remain an ongoing consideration across your isolation systems, barrier technologies and process closures. CRB’s ATMP thought leaders work with companies across a range of product specializations and through various stages of development to deliver facilities that are optimized for these life-altering, complex therapies.

    Leveraging decades of combined experience, CRB’s thought leaders guide you on industry standards and best practices, helping you select advanced technologies and identifying the critical quality attributes and process parameters that will translate to clinical outcomes and scalable processes. Our thought leaders have helped design and construct flexible facilities serving a wide range of autologous and allogeneic cell and gene therapies, including such products as lentiviral/retroviral, adeno and associated-adenoviral, CAR-T, Natural Killer and stem cell therapies. We have designed some of the world’s largest allogeneic production facilities with flexible spaces accommodating up to 12,000 liters. We have also designed some of the most flexible manufacturing facilities in the industry, providing our clients with unmatched value for developing products, regardless of phase, in a competitive and time critical environment.

    Process Architecture

    Our thought leaders are more than just industry-leading architects, designers and engineers; they also have operational expertise across each phase of drug development and manufacturing. This combined experience in process and architecture allows us to provide an effective facility design that meets your individual needs.

    Regulatory Guidance

    As active contributors to Pharmaceutical Inspection Co-operation Scheme, BioPhorum Operations Group, International Society for Pharmaceutical Engineering, Annex 1 and other international regulatory guidance documents and standards, we have a profound understanding of the transitional regulatory landscape, which enables us to interpret guidelines in context with your product portfolio. We help you tackle complex challenges, such as evolving process platforms, automation and throughput and cold-chain management.

    Facility Design

    Leveraging our FutureFacility™ concept for low-cost space utilization and flexible facility design for the seamless adoption of new processes, we deliver facilities that meet your current needs while anticipating how your processes will need to evolve for the future. As an industry leader, CRB is a champion of process closure approaches and engineering solutions, enabling complex processes to be performed in flexible facility spaces.

    Cost Benchmarking

    Our significant experience in these emerging fields allows us to facilitate rapid and accurate project cost estimates during the initial project phase. This allows for early scope definition and target value design.

    ONEsolution™

    ONEsolution improves quality, lowers cost and reduces delivery time. The end goal of an ATMP facility is to get the product to the patient. We design and build facilities that are capable of delivering the product in the right quantities and adapting to future demands. Our integrated, multidisciplinary teams deliver innovations and efficiencies that result in your successful project.

    REACHING FURTHER, TOGETHER.

    ATMPs could transform health for many patients, and all of us involved in the field, including those of us specializing in facility design, have a role to play in helping this new era of medicine to reach its potential. The end goal is to get the product to the patient. To do this, you need to design and build a facility that is capable of delivering the product in the right quantities and adapting to future demands.

    When it comes to establishing the infrastructure to successfully develop next-generation cell and gene therapies, the stakes are too high to go it alone or engage a partner without the required depth of industry expertise. You need the support of the individuals who are guiding the direction of the industry and are helping companies take the lead. Learn more from one of our thought leaders today.

    Kim Nelson, Ph.D. – director, biopharmaceutical services
    Noel Maestre, PE – biotech core team leader
    Peter Walters – process engineer
    Allan Bream – biopharmaceutical specialist
    Grace Linton, RA, AIA, LEED AP BD+C – process architect
    Matt Khair – biotech core team leader
    Chris Miles – bioprocess specialist
    Derek Ung, PE – process engineer
    Jesse Adams – senior project manager
    Mike Samudio – project director
    Matthew Kennedy — process engineer
    Ryan McDonough – biotech market sector lead
    Niranjan Kulkarni, Ph.D. – director of operations improvement

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