ABOUT CCRM - CDMO SERVICES

CCRM solves the big challenges in cell and gene therapy through the seamless integration of extensive expertise, enabling technologies, collaborative processes and specialized infrastructure.

Our team is comprised of 135+ dedicated Scientists, Process Engineers, Operators, Quality staff, and other support functions who have years of extensive experience in regenerative medicine and biopharmaceutical development and manufacturing. Located in Toronto’s MaRS Discovery District, CCRM is part of a leading-edge, highly diverse biomedical ecosystem with world-renowned clinical and academic facilities that are footsteps away.

Our scientific expertise coupled with our client-centric approach to project management allows us to work collaboratively with both emerging biotech start ups and established, global biopharmaceutical organizations and take these organizations from concept to market. CCRM’s specialized infrastructure includes 40,000 ft2 of process development and cell and vector GMP facilities, which allow for the seamless continuity of processes from lab to clean room.

CCRM has made significant investments in scale-out/up infrastructure for upstream and downstream process development, automation, and closure. Furthermore, we continue to invest in tools and talent to support custom analytics development and enable strong process controls for clients as they advance their programs into the clinic and towards commercialization.  

CCRM’s development, scale-up/out and manufacturing capabilities include:

  • Process scale-up and scale-out, closure and automation
  • Good Manufacturing Practices (GMP), induced pluripotent stem cell (iPSC) reprogramming, gene editing and differentiation
  • Automated, closed, integrated, process development (PD) and manufacturing for T-cells and natural killer (NK) cells (e.g. CAR-T, CAR-NK)
  • Manufacturing for pre-clinical safety, toxicology and efficacy testing
  • Viral vector (lentivirus, adeno-associated virus, other) upstream and downstream process development and optimization for manufacturing
  • GMP manufacturing of master/working cell banks
  • GMP manufacturing of cell and gene therapies for Phase I & II clinical trials
  • Analytical development including high-throughput screening assays, quality control (QC) testing, and ICH stability studies
  • Assessment of next-generation bioprocessing hardware and technologies
  • Custom and high-throughput media development
  • Hematopoietic stem cell (HSC) isolation and processing
  • Cryopreservation strategies
  • In-house quality control (QC) lab to support product release
  • Pre-clinical and clinical regulatory consulting

FEATURED SERVICES

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

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

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 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 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 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.

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 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.

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

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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

  • For a cell replacement therapy to be successful, you need a significant number of differentiated cells – sometimes upward of 1 billion cells per dose. Since differentiated cells have a limited proliferation capacity in comparison to pluripotent stem cells (PSCs), and some cells may not integrate into host tissue, high doses of cells are needed for cell replacement therapies. Our team has tackled the challenges of manufacturing scale-up for PSC-derived cell therapies numerous times. 

  • We look at genetic engineering approaches for iPSCs and explore creating process improvements that make editing more efficient and solutions to common challenges for gene editing iPSCs.

  • 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.

  • 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.

  • 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 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.

  • 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 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.

  • 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 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.

  • 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.

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

  • 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.

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

  • 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?

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.