Process Track RecordTechnology TransferPPQ – Process Performance & QualificationCommercial ManufacturingQuality Control and StabilityRegulatory

Commercial
Manufacturing

Providing Right First Time cGMP Manufacturing

Supporting the robust scaling of your project from clinical through to commercial scale, we are dedicated to quality excellence, delivering small molecule intermediates including high potency chemistry, payloads, linkers, payload-linker chemical intermediates, bioconjugation and Antibody Drug Conjugates (ADCs).

Simplifying your project and de-risking technology transfer, we deliver specialized, integrated services across the lifecycle of your products.

Our facility is designed with the flexibility and scalability for your commercial needs. We ensure compliance to biopharmaceutical regulations for cGMP operations.

Our dedicated and experienced technical teams are committed to ensuring your program meets its clinical and commercial goals.

Our Commercial and Process Development facilities utilize the same technologies to ensure effective scale up of your process, de-risking your overall commercial program. Additionally, we ensure that technology transfer is successful and meets all product quality requirements.

Quality is first – to patients, regulatory authorities, and our partners. Abzena’s Quality organization provides a comprehensive program of quality services to ensure compliance with regulatory requirements.

In addition to our expertise, we have the technologies and analytical capabilities to handle any of your modalities; from the simple to the most complex.

Work with us

Using an extensive and diverse range of expertise in scaling and manufacturing biopharmaceutical products, we create tailored solutions for your program.

Our agility and dedication to your program ensures a robust process to meet your commercial goals. We reliably and consistently deliver your program under cGMP and regulatory requirements.

Contact us for more information, to get a quote or to schedule a teleconference.