Biologics Drug Development Solutions - Abzena

Antibody Drug Conjugate Manufacturing: Clinical to Commercial Services

We offer clinical to commercial ADC manufacturing expertise and development services across the ADC components: antibodies, linkers, payloads, and bioconjugation.

Accelerate your ADC program with Abzena.

Antibody-Drug Conjugates (ADCs) have wide-ranging treatment potential. ADC manufacturing is challenging and requires highly skilled scientific experts that can ensure the successful and safe manufacturing of these highly potent drugs – working within state-of-the-art well-controlled manufacturing facilities. Abzena are the leading ADC payload development and manufacturing experts that can accelerate your ADC program.

ADCs are made up of three components: an antibody specific to the target associated antigen, a payload designed to kill target cancer cells, and a chemical linker to attach the payload to the antibody.

We have leading integrated development and manufacturing capabilities and expertise across all the ADC manufacturing components. Through our integrated capabilities for ADC products we can accelerate your timelines, de-risk and reduce program complexity, and effectively manage resources.

ADC Clinical to Commercial Manufacturing

We support the robust scaling of ADC clinical through to commercial manufacturing. We are dedicated to quality excellence, delivering small molecule intermediates including high potency chemistry, payloads, linkers, payload-linker chemical intermediates, and bioconjugation.

Our ADC & bioconjugates commercial manufacturing and process development facilities utilize the same technologies to ensure effective scale up of your process, de-risking your overall commercial ADC program. We also ensure that any ADC technology transfer is successful and meets all product quality requirements.

ADC Manufacturing: Process, Challenges & Solutions

Bioconjugates, ADCs & Chemistry CRO+CDMO - Abzena

Successful ADC Manufacturing Process

Our scientific team have multiple decades of experience in the field of ADC production. We have robust and refined processes that have proven to accelerate customers programs and move ADCs forwards into clinical and commercial manufacturing.

We understand that ADC manufacturing is a complex multistep process which can be divided into three stages:

  • cGMP production of the antibody
  • cGMP synthesis of the drug-linker complex
  • Conjugation to form an ADC

The conjugated antibodies then undergo extensive purification to remove therapeutic impurities. These are finished as ADC products upon the completion of fill-finishing.

Overcoming ADC Manufacturing Challenges

Linker technologies are a critical component in the development and manufacturing of ADCs. Many linkers, particularly those used in first-generation ADC bioconjugation have limitations that can impact the safety and efficacy of the ADC.

ThioBridge™ has been developed by Abzena to overcome the limitations associated with traditional linker technologies. ThioBridge™ leverages our deep understanding and expertise in conjugation chemistry.

Discover ThioBridge™ Conjugation Solution

ThioBridge™ is important for the advancement of ADCs. ThioBridge™ provides several benefits for ADC development as it addresses issues commonly associated with traditional bioconjugation technologies by:

  • Creating a very stable and uniform DAR composition
  • Improving manufacturing efficiency through a high-yielding ADC platform with up to 80% single DAR species
  • Exhibiting a high degree of stability in serum and being less prone to losing its payload in the body before it gets to its target
  • Allowing for an extensive range of linker designs to optimize the stability, loading and function of the payload
  • Providing versatility in the range of different payloads with different functions that can be attached to antibodies

Leverage our unique interconnected capabilities for ADC payloads and overall end-to-end ADC expertise to avoid unnecessary white space, extra investment in expertise, assets and additional infrastructure. Minimize your ADC manufacturing costs and risk with Abzena.

Let’s move medicine forward - Abzena

Let's move medicine forward

We enable you to bring life-changing medicines to patients in need faster. Let’s talk and move medicine forward.