CCRM provides innovative CDMO services to enable the development and commercialization of cell and gene therapies and regenerative medicine-based technologies. With our customer-focused approach customized to each client, we provide process development and cGMP manufacturing services tailored to our clients’ timelines, financing, ambitions and needs. Our team of expert engineers and scientists have over 300 combined years of cell and gene therapy experience. Our scientific expertise and know-how can help emerging and established partners in the regenerative medicine field from concept to market.

CCRM’s expertise in developing, scaling up and manufacturing cell and gene therapies includes the following areas:

  • Process scale-up and scale-out, closure and automation
  • Cell (iPSC, CAR-T, MSC, NK, HEK) process development and optimization for commercial manufacturing
  • Manufacturing For Pre-clinical Safety, Toxicology And Efficacy Testing
  • cGMP manufacturing of master/working cell banks
  • cGMP manufacturing of cell and gene therapies for Phase I & II clinical trials
  • Cell reprogramming and gene editing
  • Media formulation and development
  • Analytical assay development
  • Viral vector (LVV, AAV) process development and optimization for commercial manufacturing
  • Cryopreservation
  • Pre-clinical, clinical, and market access regulatory consulting


CCRM has extensive experience in closing and automating various cell therapy processes.

CCRM has deep experience in optimizing and developing processes for various cell types to ensure success during cGMP manufacturing. One example is the CAR-T process developed for a key international client, which is now being used to treat patients in clinical trials and with initial positive outcomes.

CCRM can develop pre-clinical processes and analytics suitable for animal toxicology and efficacy studies. We have on-site expertise in a wide range of cell drug products, formats and formulations. CCRM has experience in developing processes for animal studies from cell source to final product using cutting-edge laboratory equipment for different cell products.

CCRM routinely manufactures cGMP master and working cell banks within our Centre for Cell and Vector Production. We can maufacture cell banks for use in USFDA, EMA, Health Canada and other jurisdictions around the world. Currently, we can manufacture cell banks up to 400 vials per lot and plan to increase our throughput and capacity in late 2020.

CCRM's 40,000 sq-ft PD and cGMP manufacturing facilities are staffed with 120+ scientists, engineers, operators and support functions, with plans to grow the team by late 2020 to support increasing industry demand. We have experience in manufacturing for global clinical trials, and can provide both small-scale autologous and large-scale (200 L) allogeneic batches, as well as have scalable workflows. Our team can perform complex and highly customized manufacturing runs (CAR-T, T-cell, iPSC, NK, MSC, LVV, AAV).

CCRM has extensive experience in cell reprogramming using a variety of gene editing tools to enable the development of iPSC and iPSC-derived therapeutics.

We work collaboratively with clients to develop and optimize custom media to enable process development and cGMP scale-up of cell and gene therapies.

CCRM offers analytical assay development for cell and gene therapies. We have developed assays for immunotherapies (autologous and allogeneic) and viral vectors, as well as high-throughput screening assays.

CCRM provides process development services for both lentiviral vectors and adeno-associated viruses. Our team has completed multiple upstream and downstream projects, and successfully scaled-up to 25 L in a stirred-tank bioreactor.

CCRM can evaluate off-the-shelf cryoprotectants as well as develop customized media formulations for optimal cryopreservation of immortalized and primary cell lines. We have on-site expertise in a variety of human cell types and have developed a closed GMP process from formulation to thaw using state-of-the art GMP equipment for different cell therapy applications.

Regulatory services from Bench to Bedside
CCRM’s extensive knowledge in cell and gene regulatory affairs can help you de-risk your projects at any stage of development, from early stage preclinical planning through to global commercialization. We have experience negotiating clinical trials and new product commercialization with regulators around the world and can leverage this to help you design a go-to-market regulatory strategy appropriate to your regenerative medicine technology, saving you time and money and improving predictability.


  • Challenges of Analyzing Advanced Therapy Medicinal Products (ATMPs)

    Understanding, developing and managing analytical variability is critical to robust and reproducible manufacturing of cell and gene therapy products. Dr Steven Keizer, Director of Quality at CCRM discusses challenges around developing analytics and design-control strategy for QC methods, presented at Bio-Techne’s Cell and Gene Therapy Symposium: Challenges of Analyzing ATMPs.

  • Cell & Gene Therapy And COVID-19: New Opportunities For Global Collaboration

    Dr Michael May, President and CEO, CCRM (Canada) discusses the impact of COVID-19 on the regenerative medicine sector and how the current scenario fosters new collaborative models in a post COVID world for all stakeholders, at the inaugural Business of Regenerative Medicine Asia Pacific Symposium (Virtual) co-hosted by CCRM Australia and the NSW Stem Cell Network.

  • Planning For Commercial Success – Best Practices For Designing Cell & Gene Therapy Clinical Trials

    Cell and gene therapy applications have, in the last three years, made the jump from pure research products to commercialized products with high clinical efficacy, particularly for hematologic malignancies. This webinar elaborates on how to design early development programs and clinical trials for CGTs to ensure that the product can be commercialized successfully in all target markets i.e. can be reimbursed and adopted successfully despite small patient numbers, rare diseases, complex administration etc.

  • CCRM Corporate Video

    Watch this award-winning video about CCRM, a Canadian centre of excellence committed to revolutionizing health care by solving the big problems in regenerative medicine.

  • Inside The Centre For Advanced Therapeutic Cell Technologies

    Learn about the work CCRM and Cytiva (formerly GE Healthcare) scientists and engineers are doing inside CCRM's research and development lab, and our state-of-the-art process development lab - the Centre for Advanced Therapeutic Cell Technologies.

  • Centre For Cell And Vector Production

    CCRM, in partnership with University Health Network, has built a Good Manufacturing Practices facility to produce cells and viral vectors for Phase I and II clinical trials. The Centre for Cell and Vector Production (CCVP) is a 20,000 sq. ft. space featuring ISO Class 7/Grade B cell and viral vector clean rooms – 10 in total.


  • Innovative CDMO Services For Global Cell And Gene Therapy Leaders

    CCRM is a full-service concept-to-market CDMO. We make it easier for cell and gene therapy companies to accelerate commercialization of their emerging therapies and technologies at our full-service cGMP-compliant facility.

  • The Centre For Cell And Vector Production (CCVP)

    A world-class Good Manufacturing Practices (GMP) facility built in partnership with University Health Network (UHN),  located at MaRS, in downtown Toronto, adjacent to some of Canada’s leading hospitals and research institutes.

  • Process Development For Scaled-up hESC/hiPSC Manufacturing

    A manufacturer faced a challenge to scale up, close and optimize a suspension-based manufacturing workflow for pluripotent stem cells (PSCs). In response, CCRM developed an optimized 14-day manufacturing workflow, which produces >1010, cells, in < 12 months.

  • Animal Component Free (ACF) Media Development For Cell Therapies

    In the extremely fast-paced era of cell and gene therapies, the use of chemically defined (CD) ACF cell culture media is strongly encouraged by the regulators. However, the commercially available options are very limited or prohibitively expensive when available. At CCRM, we have developed a high-throughput, fully automated pipeline that allows us to formulate ACF and CD cell culture media fully tailored to the cell or gene therapy of interest.

  • Commercial Scale Manufacturing of Allogeneic Cell Therapy

    Allogeneic cell therapy products are generating encouraging clinical and pre-clinical results. Many of these therapies are also expected to have large market sizes and require cell doses of ≥109 cells. As therapeutic technologies mature, it is essential for the cell manufacturing industry to keep pace to adequately support commercial scale production. To that end, there is much that can be learned and adapted from traditional manufacturing fields. In this review, we highlight key areas of allogeneic cell therapy manufacturing, identify current gaps, and discuss strategies for integrating new solutions.

  • Industrializing Autologous Adoptive Immunotherapies: Manufacturing Advances And Challenges

    Cell therapy has proven to be a burgeoning field of investigation, as evidenced by hundreds of clinical trials being conducted worldwide across a variety of cell types and indications. There is now a more concerted effort among manufacturers to utilize traditional bioprocess principles to close, automate, and control these processes to ensure critical quality attributes (CQA) of the cell product are consistently maintained and manufacturing processes are cost-effective and risk-mitigated. This focused review will look at current solutions across a typical autologous or patient-matched manufacturing workflow and highlight remaining challenges toward industrialization of these processes.



661 University Avenue, Suite 1002

Toronto, ON M5G 1M1


Phone: 416-978-3751

Contact: Steven Molinski


  • Five Tips To Help Maximize Your Cell And Gene Therapy Budget

    Developing cell and gene therapies (CGTs), from discovery to commercialization, is highly complex. This can make it difficult to forecast budgets for development and manufacturing. Here are five tips to help maximize the value of your chemistry, manufacturing and controls (CMC) budget and stay on track to meet development milestones.

  • 4 Tips From The Experts: How To Tighten Your Timeline From Development To Trial

    Responsibly moving a cell or gene therapy forward as quickly as possible is a challenge associated with navigating a project’s development pipeline. Here are some general tips to assist you as your project moves from development to trial.

  • 3 Considerations When Developing Your LVV Program

    If you are looking to get a lentiviral vector (LVV) program off the ground, selecting the right contract development and manufacturing organization (CDMO) partner can be a game-changer. Expertise, production and equipment are three key considerations you should evaluate to determine if a prospective CDMO is a fit for your LVV program’s needs.

  • DiscGenics Collaboration Successfully Develops Allogeneic Therapy To Enable Efficient Manufacturing

    DiscGenics had established a novel process to generate cells for their allogeneic therapy, but knew they needed to improve the efficiency of the process as well as lower the cost of manufacturing. However, they found that many CDMOs that they approached for assistance in developing the new technology were not interested in a standalone process development project.

  • Collaborative Relationship Allows Avectas To Accelerate The Translation Of SOLUPORE™ Into The Clinic

    Avectas, a cell engineering company, was preparing its non-viral cell engineering solution technology for commercialization and required its platform to be assessed by an experienced third party. They requested support from CCRM, a Canadian centre of excellence in cell and gene therapy and a reliable partner to extend their development capacity and capabilities.

  • CDMOs: The Good, The Great And The Exceptional (And How To Tell The Difference)

    CDMOs can be critical to ensuring success for many early stage cell and gene therapy (CGT) companies with limited resources, but finding the right partner can often seem daunting in an increasingly crowded field. When evaluating CDMOs, it’s important to look beyond the basic attributes to the unique capabilities that will serve your organization best. This blog outlines the criteria for a successful CDMO partnership.

  • When And How To Engage With Your Regulator

    Whether you are developing a therapeutic or an enabling technology, you know that ambiguity can be one of the biggest hurdles to overcome in early development and can slow down or even stall decision making. One way to reduce ambiguity, and therefore risk, is to consult with regulators on your planned development activities. This blog post will provide insights into effectively engaging with regulators so that you can move your development program forward.

  • Viral Aggregation In Downstream Processing Of Lentiviral Vectors

    Viral vectors are vehicles for delivery of therapeutic DNA in cell and gene therapies. With over 1,000 cell and gene therapy (CGT) clinical trials underway globally, there is a growing need to address challenges in viral vector manufacturing – both upstream and downstream. Here we explore the concept of viral aggregation and its influence in every step of DSP for LVV.

  • Quality-By-Design Approach To Manufacturing Cell And Gene Therapies

    Implementation of a manufacturing process that assures a predefined quality of product is a critical requirement for the licensing and marketing of every cell and gene therapy (CGT) product. Learn how incorporating QbD principles at an appropriate stage of development of the product can be significantly advantageous.

  • Essentials Of Auditing In The Manufacturing Of Cell And Gene Therapies

    Read useful insights into auditing to help clients and contract manufacturing organizations (CMOs) understand this critical aspect.

  • Three Essential Considerations For Cryopreservation Of Cellular Therapies

    Cryopreservation helps cells survive both cooling to extreme temperatures and thawing back to physiological conditions. While several factors come into play, here are our top three considerations for developing cryopreservation processes that will ensure the safe and effective manufacturing of cell therapies, with minimal variability and risk to patients.

  • Understanding Cryopreservation Of Cellular Therapies

    Cryopreservation is the process of using ultra-low temperatures to preserve living cells and tissues for a prolonged time period.

  • Induced Pluripotent Stem Cells In Cell And Gene Therapy – Part 1: Understanding Reprogramming

    Reprogramming iPSCs remains an open and manual process, carried out using conventional basic research techniques. To advance cell and gene therapy (CGT) and to get products derived from iPSCs to the clinic, generation and maintenance of cells for therapeutics in a Good Manufacturing Practices (GMP) setting becomes paramount. So, how is this achieved?

  • Road To Success: Understanding Good Laboratory Practice For Cell And Gene Therapies

    Given the complexity, diversity and rapid change of technology and techniques for cell and gene therapy (CGT) products, such standardization is often difficult (but not impossible!) to achieve. With key considerations, GLP studies enable investigational new drug (IND) and clinical trial application (CTA) filings and human clinical trials.

  • Process Development For Scaled-up hESC/hiPSC Manufacturing

    A manufacturer faced a challenge to scale up, close and optimize a suspension-based manufacturing workflow for pluripotent stem cells (PSCs). In response, CCRM developed an optimized 14-day manufacturing workflow, which produces >1010, cells, in < 12 months.

  • What Are The Benefits Of An Automated High-Throughput Screening Process For Custom Cell Culture Media Development?

    We are often asked if culture media development can be customized at the discovery stage of the product, and if feasible, how it can be done. In this post, we will outline one approach that can be considered to customize media development for discovery-based processes.

  • Animal Component Free (ACF) Media Development For Cell Therapies

    In the extremely fast-paced era of cell and gene therapies, the use of chemically defined (CD) ACF cell culture media is strongly encouraged by the regulators. However, the commercially available options are very limited or prohibitively expensive when available. At CCRM, we have developed a high-throughput, fully automated pipeline that allows us to formulate ACF and CD cell culture media fully tailored to the cell or gene therapy of interest.

  • Five Steps To Ensure Your Cell And Gene Therapy Product Is GMP Compliant

    To prepare the product for in-human testing clinical protocols are developed in consultation with the regulatory authorities, a target patient population is identified, clinical investigators and an appropriate contract research organization are selected, and funds are obtained. What is sometimes overlooked, or left to the last minute, is the less-than-glamorous, but still critical, manufacturing steps that ensure a new, potentially life-saving treatment reaches patients in a safe and reliable form. In this post we will map the five critical steps that require thoughtful measured consideration for a CGT product to be produced in a good manufacturing practices (GMP) facility.

  • Concentration And Reformulation Of Cellular Immunotherapies – A Major Downstream Processing Step

    Cellular immunotherapies (e.g. CAR-T cells) are primarily used as an autologous therapy to treat cancer. As such, these therapies are currently generated in small batches for each patient. To generate enough modified cells for a single treatment, cells are expanded in volumes from 1-10 L. In the final step of downstream processing (DSP) for immunotherapies, cells cultured in large volumes must be concentrated and reformulated into smaller volumes (e.g. 20-100 mL) suitable for delivery to patients. In this post, we will outline the key steps for concentration and reformulation and highlight specialized equipment needed for this critical unit operation.

  • Considerations For The Use Of Stable Producer Lines In The Manufacturing Of Lentiviral Vectors

    There are many challenges with transfection-based protocols for producing LVVs at large scale. Here we will take a closer look at the use of stable producer cell lines as an alternative to transient transfection for the manufacture of LVVs.