Bioconjugate & ADC Process Development - Abzena

Bioconjugate Process Development & Optimization

Seamless upstream and downstream bioconjugate process development services for complex bioconjugates such as antibody-drug conjugates (ADCs), antibody-oligonucleotide conjugates (AOCs), radionuclide drug conjugates (RDCs) and more, supporting programs from concept to patient.

Process Development Info Sheet

Minimize risk, timelines, and costs through our integrated bioconjugate process development approach.

Optimizing production processes for bioconjugates requires specialized expertise in bioconjugation services and bioconjugate process development consistent product quality, scalability, and regulatory compliance. At Abzena, we apply decades of experience in bioconjugation process development, optimization and scale-up, to successfully transfer existing processes, or develop new, innovative processes that meet your objectives.

We provide bioconjugation services and bioconjugate process development for complex therapeutics such as ADCs, AOCs, RDCs and more, providing expert support for both clinical and commercial manufacturing processes.

Our bioconjugate process development approach is defined and designed to ensure scale-up directly from bench scale to final manufacturing. By utilizing our deep knowledge of complex chemistry and bioconjugation we rapidly develop and streamline your program development and commercial timelines.

An experienced team of process, analytical and manufacturing experts carry out manufacturing in an upgraded facility with well-established controls (engineering, administrative, and PPE controls) for handling cytotoxic materials.

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Bioconjugate Process Development Capabilities

Our experience goes beyond antibody-drug conjugates (ADCs), including bioconjugates, oligonucleotides, nanoparticles, and vaccines.

Development capabilities include:

  • Process development for small molecules, including high potency chemistry
  • Multiple linker chemistries
  • Design of antibody-drug conjugates and antibody-oligonucleotide conjugates
  • Bench scale process characterization and validation
  • Design of statistical experiments to optimize processes
  • Transfer verification optimization of your process
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Bioconjugate Process Design and Optimization

Material generated during process development is used to produce early-stage material for analytical and formulation development.

Process Development teams work closely with Analytical Method Development (AMD) to determine critical quality attributes. We design your processes to optimize yields and remove impurities and maximize product recovery while maintaining efficient and scalable workflows.

We have years of experience in product characterization and candidate evaluation, supporting the selection of the best molecules for progressing into clinical studies.

Early candidates can be produced from different antibodies, types of linkers and payloads to screen for the most potent solution for your target.

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Our process design capabilities include:

  • Conjugation reaction optimization
  • Chromatographic purification steps including ion-exchange, hydrophobic interaction, metal affinity, etc.
  • Column chromatography from 1ml through 20L of bed volume
  • TFF step optimization
  • Filter sizing studies
  • Lyophilization cycle development
  • Stability on process intermediates and process hold steps
  • Determination of Critical Quality Attributes (CQAs) and Critical Process Parameter (CPPs) validation

Ask Abzena: What is Bioconjugate Process Development?

What are your drug development goals? - Abzena

Bioconjugate process development focuses on designing and optimizing manufacturing processes for complex therapeutics that combine biologics with chemical payloads. This includes antibody-drug conjugates (ADCs), antibody-oligonucleotide conjugates (AOCs), and other targeted conjugates. Effective bioconjugation services require expertise in linker chemistry, conjugation reactions, purification, and scalable manufacturing to ensure consistent product quality and regulatory compliance.

Bioconjugate Stability Studies

Offering a full spectrum of services, we support stability studies for drug substance, drug product and in-use studies in accordance with ICH guidelines.

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Stability-indicating assays are identified early through forced degradation studies performed during process development.

Following completion of stability time-point testing, a final stability summary report is provided to support clinical studies and market authorization applications.

Analytical Development for Bioconjugates and ADC’s

Bioconjugate & ADC Formulation Development - Abzena

Analytical methods are essential to all aspects of preclinical process development, informing critical decisions and de-risking subsequent development. For the process development of bioconjugates and ADCs we measure drug-to-antibody ratio (DAR), assess conjugation efficiency, determine conjugation site and evaluate product homogeneity through specialized chromatographic methods and advanced mass spectrometry. This data drives process refinements that maintain consistent yields, potency, and overall product safety, supporting a robust and scalable conjugation strategy.

Analytical Method Development

Advance Your Bioconjugate with Confidence

Bioconjugates, ADCs & Chemistry CRO+CDMO - Abzena

Partnering with Abzena provides access to advanced bioconjugation services and bioconjugate process development expertise, supporting scalable manufacturing and reliable ADC development.

Our expertise in process development for bioconjugates reduces development and manufacturing risks, whilst enhancing efficiency. This process positions your bioconjugate for successful clinical and commercial outcomes.

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Latest News + Insight

On Demand Webinar: Process Development of ADCs and Bioconjugates

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Blog: How Process Development Can Streamline Your Biologic's Development

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Article: Optimizing Process Development for Biologics Interview

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Let's move medicine forward.

Using a diverse range of expertise in developing and manufacturing ADCs, bioconjugates and linker payloads, we create tailored solutions for your program. We adapt our approach to shorten lead times and develop risk mitigations strategies to ensure your overall success in delivering vital medicines to patients safely.

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