We, at NORCAL GMP, are proud to offer a wide range of capabilities for cGMP manufacturing of monoclonal antibodies. Our facility includes a fully qualified 15,000sq. ft. facility including an ISO7 cleanroom spanning 3500sq. ft., equipped with all the necessary equipment for efficient production. A standout feature is our 500L single-use bioreactor, enabling scalable production and purification.
At NORCAL GMP, we have assembled a highly trained and qualified team across various departments, including manufacturing, facilities, supply chain, quality control, and quality assurance. This ensures that our clients benefit from the expertise and experience of professionals who understand the intricacies of regulatory compliance and industry standards.
Our track record speaks for itself, with a history of successful drug substance production and campaigns. Furthermore, our drug product has been utilized in Phase I and Phase II clinical trials, underscoring the quality and reliability of our manufacturing processes.
Antibody Production
To maintain the integrity of the products, we have established qualified and monitored cold storage facilities. Our comprehensive storage capabilities include 2-8C refrigerators, a walk-in cold-room, -20°C and -80°C freezers, and -196°C LN2 dewars. These facilities enable us to handle and preserve our materials under optimal conditions throughout the manufacturing process.
We have commissioned our facilities and equipment with remote monitoring capabilities, allowing us to closely monitor critical systems such as power, water generation, HVAC, neutralization, and backup generators. This remote monitoring ensures continuous oversight and swift response to any deviations or issues.
With our dedicated quality control lab, we conduct rigorous in-process and release testing to ensure that all products meet the required specifications. Moreover, we have implemented stability programs for both drug substance and drug product, providing a comprehensive assessment of product quality over time.
We understand the importance of IND submissions in advancing products through clinical development. That's why we offer IND submission support to our clients, leveraging our expertise to streamline the regulatory process and accelerate the path to clinical trials.
Quality documentation is a top priority for us. We have established robust and audit-ready documentation systems, ensuring that all necessary records are in place. This commitment to quality and compliance facilitates smooth regulatory inspections and audits.
In summary, NORCAL GMP offers a wide array of capabilities for cGMP manufacturing of monoclonal antibodies. Our fully qualified cleanroom, advanced equipment, trained teams, successful production history, comprehensive cold storage, remote monitoring, quality control lab, stability programs, IND submission support, and quality documentation make us a trusted and reliable partner for efficient and compliant manufacturing solutions.
