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

Clinical Commercial

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.

Let’s move medicine forward.

The asset you’re developing right now can make a real difference for human health. Work with us and benefit from our extensive and diverse range of expertise in scaling and manufacturing biopharmaceutical products to accelerate and maximize the potential of your investment in human health.