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661 University Avenue, Suite 1002, Toronto, ON, M5G 1M1, CA
CCRM AND MIP ANNOUNCE THEY HAVE EXECUTED A LETTER OF INTENT TO PARTNER IN THE DEVELOPMENT AND OPERATION OF A BIOMANUFACTURING CAMPUS AT MCMASTER INNOVATION PARK CCRM TO LEVERAGE MIP-MCMASTER UNIVERSITY ECOSYSTEM, SOUTHERN ONTARIO LIFE SCIENCES INNOVATION CORRIDOR MIP TO LEVERAGE CCRM AS A NEXUS OF MANUFACTURING CAPABILITY AND COMMERCIALIZATION WITHIN THE GLOBAL REGENERATIVE MEDICINE […]
Released By CCRM
Avectas is an Ireland-based cell engineering technology company developing a unique intracellular delivery platform to enable ex vivo cell-based therapies. The company’s SOLUPORE ™ technology is an efficient, non-viral cell engineering solution that allows efficient transfer of cargo into cells while maintaining very high levels of cell viability and functionality. DOWNLOAD TO LEARN MORE>>>>
Outsourcing to a contract development and manufacturing organization (CDMO) 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 […]
Factories aren’t dead, they’re just adding value
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. Companies may […]
CCRM and Cytiva, formerly part of GE Healthcare Life Sciences, renew collaboration agreement for Centre for Advanced Therapeutic Cell Technologies
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. In a previous post, we outlined the key steps in downstream processing […]
New collective voice for the ecosystem launches first white paper
panCELLa and CCRM collaborate to benefit academia and industry
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. Generally, extensive development is needed to mature an early-stage process to commercial manufacturing because of the biological complexity of the products. However, inadequate process knowledge and […]
Our previous posts on quality management systems and steps to ensure your cell and gene therapy (CGT) product is Good Manufacturing Practices (GMP) compliant alluded to auditing in the context of a larger manufacturing workflow. This post provides useful insights into auditing to help clients and contract manufacturing organizations (CMOs) understand this critical aspect. What […]
Cryopreservation helps cells survive both cooling to extreme temperatures and thawing back to physiological conditions. Our previous post covered the importance and challenges involved in cryopreservation of cellular therapies. 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 […]
March 3, 2020 (DUBLIN, Ireland, TORONTO, Ontario) — Avectas, a cell engineering technology business, and CCRM, a leader in developing and commercializing cell and gene therapies, today announced they have entered into a collaboration to accelerate the translation of Avectas’ non-viral cell engineering platform (Solupore®) into the clinic. Cell and gene therapies offer the potential to dramatically transform the […]
Cryopreservation is the process of using ultra-low temperatures to preserve living cells and tissues for a prolonged time period. In a typical immunotherapy commercial manufacturing workflow, cells may be selectively isolated from peripheral blood or tumour tissues, genetically engineered, activated and expanded to relevant doses, harvested, packaged and cryopreserved, before transporting the final cellular product […]
ACF media achieved comparable performance to serum containing
What is an Induced Pluripotent Stem Cell? Stemming (pun intended) from the fundamental question in developmental biology around whether cellular differentiation could be reversed – like many transformative scientific discoveries – identification of induced pluripotent stem cells (iPSCs) was a curiosity-induced accident. In their foundational 2006 study, Takahashi and Yamanaka determined that fully differentiated adult […]
CCRM and GE Healthcare Life Sciences develop proprietary media formulations for Platelet BioGenesis
A Transparent and Flexible Approach to Manufacturing
An optimized 14-day manufacturing workflow which produces > 10^10 , cells was developed in < 12 months
For Global Cell and Gene Therapy Leadersin
Good Laboratory Practice (GLP) studies are essential for generating nonclinical study data supporting drug product submissions or applications for human use. According to the most basic definition, GLP is a set of principles that can be applied to ensure the quality and integrity of non-clinical laboratory studies. GLP provides a means to standardize the results […]
Cell therapy has proven to be a burgeoning field of investigation, evidenced by hundreds of clinical trials being conducted worldwide across a variety of cell types and indications. Many cell therapies have been shown to be efficacious in humans, such as modified T-cells and natural killer (NK) cells. Adoptive immunotherapy has shown the most promise […]
Allogeneic cell therapy products are generating encouraging clinical and pre-clinical results. Pluripotent stem cell (PSC) derived therapies, in particular, have substantial momentum and the potential to serve as treatments for a wide range of indications. Many of these therapies are also expected to have large market sizes and require cell doses of ≥10 9 cells. […]
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.
(“off the shelf”)
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. Compendial & […]
In Part 1 of our series on LVV manufacturing we covered scale-up of upstream processing steps. In this post we will look at the key steps in DSP. The industry “gold-standard” for recovery of purified and concentrated LVV is 10-20 percent. Improving on this low recovery is an opportunity to reduce the cost of manufacturing […]
In an introductory post on lentiviral vector (LVV) manufacturing for cell and gene therapies (CGTs) we touched upon the 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. […]
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, […]
When we think about CGTs what most often comes to mind is the early stage scientific innovation responsible for finding new ways to treat diseases.
Simply put, a bioreactor is a stand-alone cell culture vessel enabled with sensors. 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). Continuous, in situ monitoring of these parameters allow for a deep understanding of the growth environment of […]
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. To get us started: IQ stands […]
In a previous post we introduced chimeric antigen receptor T-cell (CAR-T) therapy – a new form of cancer therapy based on genetically reprogramming the body’s immune system that has been described as a “breakthrough” and “revolutionary” by the medical and scientific communities. This post will explore how developing customized solutions for system closure can solve […]
Making the Decision to Engage a Contract Development and Manufacturing Organization (CDMO) 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. Each developer will have unique needs depending largely on the stage of their technology. For […]
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. AAVs are most commonly used to deliver gene therapies – meaning they will be administered directly […]
Conventional cancer treatments (e.g. surgery, chemotherapy/radiation) do not specifically target cancer cells and, as a result, can cause extensive off-target damage, and complications for patients. In the last several years, ground-breaking research and advancements in genetic engineering have led to the development of a novel treatment strategy, known as immune therapy, that is rapidly emerging […]
New cell and gene therapies are rapidly being translated into the clinic. The potential for these new therapies is driving the industry to develop safe and reproducible cell culture systems. Increasingly, this has meant including the development of a unique, chemically defined (CD) and animal component free (ACF) medium as a standard part of the […]
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