What are the IDMO services offered at Cellares?
Cellares IDMO can support your cell therapy portfolio throughout the drug development lifecycle from preclinical development to commercial scale manufacturing. Core services offered by Cellares IDMO include process development and testing, analytical development, clinical & commercial GMP manufacturing, quality assurance/quality control services, and regulatory support for cell therapies.
What cell therapy modalities does Cellares IDMO support?
Cellares Cell Shuttle is a platform that supports autologous & allogeneic cell therapy approaches based on suspension cells, leveraging transduction or electroporation gene editing modalities.
Does Cellares offer scale-up development?
Yes, Cellares IDMO Process Science Teams support transfer and scale-up of our clients’ processes throughout the drug development lifecycle.
Does Cellares IDMO apply a quality-based approach to product development?
Cellares IDMO utilizes a Quality by Design (QbD) approach to support our clients’ new and innovative cell and gene therapy drug product development lifecycle from preclinical to commercial GMP manufacturing by leveraging the flexibility of our fully closed, automated, and scalable Cell Shuttle platform. This strategy enables a streamlined development process guided by a thorough understanding of fundamental biology and engineering principles underlying a process. By employing a QbD approach to drug product development, Cellares dramatically decreases drug product manufacturing costs, while increasing process robustness and technology transfer speed at which a drug product candidate can progress through the drug development lifecycle.
Cellares is committed to designing, implementing, and maintaining an effective cGMP Quality Management System in order to support and deliver a high quality, safe, and robust manufacturing process for our clients. Our innovative process empowers advanced biotech organizations with the ability and flexibility of a scalable manufacturing solution.
We achieve this through:
1. Instilling a deep Quality culture within the organization that promotes integrity, accountability, communication, and continuous improvement
2. Ingraining Quality into each and every process
3. Training talented, creative, and passionate individuals
4. Collaborating with our clients and their requirements
5. Full compliance and transparency with regulatory agencies
Does Cellares supply preclinical material?
Yes, Cellares IDMO has the ability to support you throughout the drug development lifecycle, including the supply of drug products for preclinical development activities.
How does Cellares support clients’ regulatory needs?
Cellares recognizes that early and frequent communication with global regulatory agencies is paramount to advancing your cell therapy portfolio and accelerating access to these life saving therapeutics. Cellares' team has the expertise and experience to support you through these engagements with global regulatory agencies.
Our Cellares regulatory compliance and CMC teams will work with you on developing your CMC strategy and plan and support your successful regulatory submissions.
Can Cellares IDMO support clients’ process/analytical development needs?
Cellares IDMO Process Development team provides a fully integrated framework to catalyze your early to late stage cell therapy processes. Our in-house cell therapy experts support our clients to confidently arrive at an automated, reproducible, and scalable solution using our state-of-the-art Cell Shuttle technology.
Cellares IDMO clients will also have access to our expert Analytical Development team for seamless assay adoption or development, leveraging automated technology. This allows seamless integration of critical in-process and final product characterization data, unlocking speed and eliminating wait times for your cell therapy manufacturing process.
Can Cellares IDMO support clients’ manufacturing needs?
Cellares IDMO offers clients access to strategically located world class cGMP compliant facilities, currently in South San Francisco, CA and Bridgewater, NJ) to support clinical and commercial scale manufacturing needs. Through vertical integration with our Cell Shuttle platform, our IDMO is well-positioned to support your cell therapy drug product portfolio from preclinical development to post-commercial licensure
Does Cellares IDMO support the adoption of the Cell Shuttle technology and tech transfer into cGMP manufacturing?
Cellares IDMO offers clients the ability to partner through our Technology Adoption Program (TAP), which is specifically designed to automate and transfer your cell therapy manufacturing processes onto our Cell Shuttle platform. Upon successful completion of TAP, a frictionless transition to GMP manufacturing can occur at any facility within our IDMO Smart Factory network.
What type of cyber security does Cellares provide to protect customers’ data? What infrastructure does Cellares have in place to ensure client data is never lost?
Cellares takes cybersecurity and the protection of customer data seriously. We’ve invested in building out a robust IT/data infrastructure that allows us to detect, prevent, and continuously upgrade our systems and processes to potential vulnerabilities. We also have comprehensive recovery and business continuity plans with data backup and recovery to ensure we maintain the integrity and provenance of client data at all times.