Cell & Gene Therapy

CATALYSTS FOR THE NEXT GENERATION OF MEDICINE

As interest in the cell and gene therapy market continues to grow at a rapid pace, novel processes are demanding facility and technology infrastructures unlike any that have existed before. 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.

CATALYSTS FOR SUCCESS DELIVER IN ALL AREAS

CRB’s Cell and Gene “Catalysts for Success” 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.

Market-Defining Experience

Leveraging decades of combined experience, CRB’s catalysts 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.

Process Architecture

Our catalysts 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 PIC/S, BPOG, ISPE, 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

CRB’s 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.

PROVEN TRACK RECORD

Our catalysts have helped to 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 (NK) 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. CRB has 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 timecritical environment.

MEET YOUR CATALYSTS

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. Introduce catalysts to your project today.

CRB’S CELL AND GENE CATALYSTS FOR SUCCESS

As interest in the cell and gene therapy market continues to grow at a rapid pace, novel processes are demanding facility and technology infrastructures unlike any that have existed before. 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 Cell and Gene “Catalysts for Success” 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.

Kim Nelson, Ph.D. – Director, Biopharmaceutical Services
Noel Maestre, PE – Biotech Core Team Leader
Peter Walters – Process Engineer
Allan Bream – Biopharmaceutical Specialist
Grace Linton, AIA, LEED AP BD+C – Process Architect
Matt Khair – Biotech Core Team Leader
Chris Miles – Bioprocess Specialist
Derek Ung, PE – Process Engineer
Jesse Adams – Snr. Project Manager
Mike Samudio – Project Director

How Can We Help With Cell & Gene Therapy?