See More

Subscribe to Email Updates

Popular Stories

Viral Aggregation in Downstream Processing of Lentiviral Vectors
The Canadian Regulatory System for Cell and Gene Therapies
Understanding the Role of the Quality Unit in Good Manufacturing Practices
IQ, OQ and PQ: Why Are They Important in the Manufacturing of Cell and Gene Therapies?
Planning Is Everything - Quality Control Testing in Cell and Gene Therapy
August 03, 2021

CCRM works with customers in a collaborative manner to enable them to accelerate the commercialization of new technologies. Our recent work with Nkarta Therapeutics is a great example.

Nkarta is a clinical-stage, cell therapy company focused on engineering natural killer (NK) cells for the treatment of cancer. As an emerging biotechnology company, Nkarta sought a contract development and manufacturing organization (CDMO) with a high degree of flexibility that could support its analytical development and manufacturing needs.

CCRM’s team is comprised of over 135 dedicated staff with years of experience in regenerative medicine, biopharmaceutical development and manufacturing. It had the extensive expertise Nkarta was looking for.

Nkarta needed a CDMO partner to help advance its programs into clinical trials. CCRM’s regulatory experts helped Nkarta navigate a path to successful pre-Investigational New Drug (IND) meetings.

CCRM ensures customer success through a comprehensive approach based on the following four pillars:

  1. Extensive expertise
  2. Enabling technologies
  3. Collaborative processes
  4. Specialized infrastructure

Here we’ll focus on how CCRM’s dedication to collaborative processes helped Nkarta advance its therapy and prepare for a successful IND filing


Strong Communication Helped to Meet Tight Timelines

The foundation of any successful relationship is good communication. To ensure the project stayed on track, CCRM’s staff worked closely with Nkarta’s project leaders. Lead scientists from both organizations routinely exchanged ideas and strategies to keep the work moving forward. CCRM’s experts worked hard to understand Nkarta’s needs and provide specialized services and support.

By setting the project on the right path early, CCRM’s experienced professionals helped Nkarta identify the steps to success. Leveraging their decades of collective experience, the team at CCRM knew how to identify risks and provide mitigations. With that approach, they avoided costly dead-ends and helped Nkarta reduce the potential impacts to its timeline and budget.

Working with CCRM’s Regulatory Team Advanced Nkarta Towards Clinical Trials

With the same goals in mind, CCRM’s in-house regulatory experts leveraged their experience in working with Health Canada, the U.S. Food and Drug Administration, European Medicines Association and other global regulators. Further, Nkarta benefited from access to CCRM’s facilities that are designed to comply with North American Good Manufacturing Practices (GMP) and the European Union’s Advanced Therapy Medicinal Products Guidelines.

CCRM had the Right Tools for the Job

CCRM’s GMP-compliant facility, the Centre for Cell and Vector Production, houses CCRM’s Gammacell® irradiator (Best™ Theratronics) – a piece of equipment that is not commonly found in CDMOs. Nkarta utilized the irradiator, along with other cutting-edge tools, in processes that proved instrumental to the project.

Transparency Made Budget Discussions Easy to Approach

Dr. Nadir Mahmood, Chief Financial Officer and Chief Business Officer of Nkarta, played an active role in generating cost estimates and forecasts and discussed the project’s finances on frequent calls with CCRM representatives. Regular communication ensured financial estimates were tracking well, and that clinical supply would meet critical timelines.

Dr. Mahmood said CCRM and Nkarta’s cooperation felt “fluid,” and that CCRM’s willingness to connect and brainstorm was “critical” to the project’s budgetary success.

Why We Collaborate

By working openly together, organizations like CCRM and Nkarta can create synergies to advance the field.

Using the four pillars of its comprehensive approach as a foundation, CCRM helped Nkarta move towards realizing the potential of NK cells to treat cancer. We’re proud of this accomplishment and look forward to maintaining the momentum of our collaboration. `

To learn more about CCRM’s facilities, services and technologies, please visit our website.

To learn more about Nkarta and its research, visit Nkarta’s website.

To learn more about our work with Nkarta read our latest case study.

To learn about the commercialization of regenerative medicine, ask questions, or begin your journey with us, please email



Tell us what you thought about this post.

You may also like:

manufacturing GMP manufacturing standard operating procedure

Environmental Monitoring in the Manufacturing of Cell and Gene Therapies

Environmental monitoring (EM) is an important laboratory control that provides information on the cleanliness of the are...

manufacturing quality assurance GMP manufacturing cell and gene therapies good manufacturing practices GMP good laboratory practice GLP GMP facility

3 Ways Your CDMO Can Help You Avoid Supply Chain Problems

The COVID-19 pandemic has significantly disrupted supply chains and production schedules around the world. It underscore...

manufacturing process optimization GMP manufacturing cell and gene therapies CDMO GMP facility regulatory approval

Five Tips to Help Maximize Your Cell and Gene Therapy Budget

Developing cell and gene therapies (CGTs), from discovery to commercialization, is highly complex. Further, as this sect...