Why Abzena?
Our focused approach.
Developing an efficient, scalable, validated, and cost-effective manufacturing process is essential for success in today’s competitive biologics markets.
Whether you need assistance developing a new process, are improving existing processes, or are preparing to manufacture your product, you will benefit from our in-depth expertise.
Through a comprehensive technology transfer program, we deliver a successful scale-up model to ensure a robust and consistent manufacturing process from clinical to commercial scale.
We collaborate with your team to de-risk the pathway to commercialization, ensure manufacturability, and deliver a quality biologic medicine to the patient.
To help promote innovation and continuous improvement Abzena has a framework following the ICH guidance ‘Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management’. Working collaboratively alongside you, this will support the management of post approval Chemistry and Manufacturing Control (CMC) changes for your product. We use a scientific and risk-based approach to inform your decision making, ensuring that post approval changes are fit for purpose. Our team are experienced in creating robust data packages that help facilitate regulatory review.
Abzena has extensive experience in cGMP and non-GMP production for recombinant proteins, antibodies and conjugates for preclinical, clinical and commercial materials. We have expertise in employing single-use technology allows for rapid turnaround times and cost-effective solutions. Our biologics manufacturing facilities located in San Diego, CA, provides world-class cGMP manufacturing.
The leading biologics CDMO + CRO that accelerates drug development, moving medicine forward for patients in need.