ABOUT CCRM - CDMO SERVICES

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

FEATURED SERVICES

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.

VIDEOS & WEBINARS

  • 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.

RESOURCES

  • 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.

CONTACT INFORMATION

CCRM

661 University Avenue, Suite 1002

Toronto, ON M5G 1M1

CANADA

Phone: 416-978-3751

Contact: Steven Molinski

FEATURED ARTICLES

  • 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.

  • 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.

  • 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.

  • How To Scale-Up Lentiviral Vector Production Part 2: Considerations For Downstream Processing

    Lentiviral vectors (LVV) are a key component in the production of cell and gene therapies. Today, even with the proliferation of cell and gene therapies in development, LVV is still produced using legacy methods employed in basic research. Overcoming technical challenges in the scale-up of LVV production is a major focus for the industry. Here we break down DSP into unit operations and understand how process innovations are contributing to scalability at each step.

  • Planning Is Everything - Quality Control Testing In Cell And Gene Therapy

    Compliance with quality control (QC) standards is a basic requirement for products manufactured under good manufacturing practices (GMP) conditions. In this post we will explore the main compendial QC tests that ensure cell and gene therapies are safe for use in patients, and important considerations for integrating QC testing into the manufacturing process.

  • How To Scale-Up Lentiviral Vector Production Part 1: Considerations For Upstream Processing

    Lentiviral vectors (LVV) are a key component in the production of cell and gene therapies. Today, even with the proliferation of cell and gene therapies in development, LVV is still produced using legacy methods employed in basic research. Overcoming technical challenges in the scale-up of LVV production is a major focus for the industry. This blog explores the principles that govern the scaling of upstream processing (USP).

  • How Can A Closed CAR-T Manufacturing Process De-Risk Your Process, Reduce Costs And Improve Efficiency?

    Though promising, CAR-Ts remain costly and largely a difficult manual manufacturing process. To create long-term solutions developers are working on process improvements, like system closure, that will boost safety and reliability, and help to reduce costs. This blog will explore how developing customized solutions for system closure can solve a key technical bottleneck and advance CAR-T manufacturing.

  • IQ, OQ And PQ: Why Are They Important In The Manufacturing Of Cell And Gene Therapies?

    Understanding the cell and gene therapy (CGT) development process from start to finish often comes down to learning the language. For individuals more familiar with the early R&D steps in this process, terms like IQ, OQ and PQ – associated with later manufacturing steps – may be completely new. Understanding IQ, OQ and PQ will set you up for success in transferring your process to a good manufacturing practices (GMP) facility.

  • What Is A Bioreactor And How Is It Used In Cell And Gene Therapy?

    Bioreactors differ fundamentally from traditional R&D cell culture in their ability to monitor and control key parameters such as temperature, pH, and dissolved oxygen (DO). This blog explains the different types of bioreactors and how they facilitate process development.

  • How Can A Contract Development And Manufacturing Organization Advance A Cell & Gene Therapy Product?

    There is no one-size-fits-all answer for cell and gene therapy developers seeking to determine why, and more importantly when, to outsource manufacturing or process development to a CDMO. This blog covers the services and benefits of working with a CDMO to help you through the process.

  • What Is The Best Way To Manufacture Lentiviral Vectors For Cell And Gene Therapies?

    In the field of cell and gene therapy, there are two main types of viral vectors: adeno associated virus (AAV) and Lentivirus (LV). The manufacture of these vectors is dependent on the regulatory requirements dictated by its end use. This blog outlines the challenges for optimization of scaled-up LV manufacturing processes and new technologies being used to solve these challenges.