Bioconjugate & ADC Formulation Development - Abzena

Bioconjugate Formulation Development

Tailored formulation development for bioconjugates including ADCs, AOCs, RDCs and more.

Formulation Development Info Sheet

Robust formulation development for bioconjugates tailored to your needs.

Customized for your bioconjugate or antibody drug conjugate (ADC) development phase, Abzena aligns your drug product with your preferred target product profile (TPP) with a comprehensive range of formulation development packages including stable liquid and lyophilized formulations.

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We select your best lead candidate through screening of optimal buffer conditions and formulation options to inform successful drug substance manufacturing conditions and drug product forms that support long-term stability.

Our team is experienced in bioconjugate formulation development and ADC formulation development for a wide range of therapeutic molecules such as peptides, proteins, monoclonal antibodies and antibody-drug conjugates (ADCs).

Ask Abzena: What is Bioconjugate Formulation Development?

Biologics Formulation Development - Abzena

Bioconjugate formulation development is the process of designing stable, effective, and manufacturable formulations for complex therapeutics such as antibody-drug conjugates (ADCs), antibody-oligonucleotide conjugates (AOCs), radioconjugates, and other bioconjugates. It evaluates factors including buffer selection, excipient compatibility, protein stability, aggregation risk, concentration, viscosity, and route of administration to support successful clinical and commercial development.

Bioconjugate Formulation Development Capabilities

We have the latest analytical equipment and methods to evaluate the integrity of your drug under an array of conditions to inform optimal formulation constituents and forms.

Our capabilities include:

  • UHPLC systems
  • Biophysical stability assessment platforms and particle size assessment equipment such as Prometheus, UNcle and ZetaSizer Ultra
  • Mass spectrometry instruments (TOF MS, QTOF MS)
  • Microfluidic platform (LabChip)
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Bioconjugate Formulation Development Workflow

Abzena applies a flexible and customizable approach to achieving your bioconjugates target product profile (TPP). With timelines always in mind, Abzena applies practical and phase-appropriate processes with early-stage (pre-Phase I) formulation activities focused on rapid progression to IND – “fast to clinic,” whilst later-stage formulation activities are focused on providing the best product – “best in clinic.”

Stage 1: Preformulation​

  • Thermal ramp experiment is performed on the molecule in 14 platform buffers in order to establish optimal buffer conditions

Stage 2: Formulation Development​

  • Extended thermal stability of up to four lead formulations from Stage 1​
  • Freeze/thaw stability of up to four lead formulations from Stage 1​
  • Agitation stress stability (optional)​
  • Photostability (Light stress) stability (optional)

Stage 3: Concentration Optimization​

  • Higher concentration study (e.g. if administration via SC injection is preferential to IV infusion)

Stage 4: Injectability Assessment​

  • Theoretical injection forces are calculated by measuring the viscosity at a range of shear rates to mimic the motion of the drug through the syringe and needle

Stage 5: Syringe-ability Assessment​

  • The effects of being ejected from a syringe and needle at high shear rates can be tested by loading of the drug product into the specified syringe/needle system, followed by syringing out of the material​

Stage 6: Lyophilization Assessment​

  • Assessment of the molecule as a lyophilized product can be performed, in which its stability to the freeze-drying as well as buffer optimization is investigated​
  • This can occur either at this stage (e.g. for a mAb) or pre-tox/phase 1 studies (for an ADC)

Stage 7: Container Interaction Studies​

  • Compatibility of the formulated drug product with IV bag systems and typical clinical diluents such as saline (for intravenous administration)​
  • Compatibility of the formulated drug product with syringe/needle systems, pre-filled syringes or cartridges (for subcutaneous or intra-ocular administration)​
  • Determination of extractables and leachables from container/closure system

Stage 8: Formulation Robustness Studies​

  • Extended thermal stability of 21 iterations of the lead formulation from Stage 2, to cover a design space based upon manufacturing tolerances and limits​
  • DoE interpretation of data determines the effects of each parameter change and can identify potential risks in excipient​ level/pH/DP conc. deviations during manufacturing

Stage 9: Thermal Stability in Final Format​

Extended thermal stability of the final formulation assessed in the final format i.e. pre-filled syringes, cartridges, plastic/glass vials, etc

Challenges in ADC and Bioconjugate Formulation Development

ADC and bioconjugate formulation development must address the structural complexity of these molecules while maintaining stability, potency and product quality. Key challenges include aggregation risk, protein stability, viscosity, drug-to-antibody ratio (DAR) stability, lyophilization requirements and the intended route of administration.

Formulation screening helps identify buffer systems and excipients that support long-term stability while reducing aggregation risk. For high-concentration formulations, viscosity must also be managed to support manufacturability, filling and administration.

For ADCs, maintaining DAR stability is essential to preserve efficacy, safety and regulatory consistency. Where liquid formulations are not suitable, lyophilization may help improve shelf life and storage stability. Early assessment of the route of administration also ensures the final formulation supports patient needs, container compatibility and commercial manufacturing requirements.

We understand the important role that formulation development for bioconjugates plays in ensuring both clinical and commercial success for your program. From early discovery through commercialization, our experts work with you side-by-side, functioning seamlessly as part of your team to ensure that your new medicine reaches patients in need. With quality at the forefront of everything we do, we plan the best route, steering your drug program toward regulatory approval.

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What sets our formulation development services for bioconjugates apart?

  • Overall we have delivered over 1400+ programs, developing formulations for a diverse range of therapeutic modalities
  • Fully integrated, comprehensive formulation development support across: ADCs, AOCs, Radioconjugates and other bioconjugates
  • Experience of supporting clients with all stages of drug development, from discovery through product launch and subsequent life-cycle management
  • Problem solving and applying knowledge to provide product-enabling solutions e.g. addressing viscosity or solubility issues
  • A number of returning customers emphasize their confidence and trust in our complex biologic development abilities

Preclinical Analytical Development Support

Bioconjugate & ADC Formulation Development - Abzena

Abzena provides a robust suite of analytical method development services designed to support bioconjugate formulation development. These analytical methods inform critical decisions and de-risk subsequent development phases. Our bioconjugate formulation services assess protein stability, aggregation risk, viscosity, drug-to-antibody ratio (DAR) stability, and excipient compatibility to identify formulations suitable for the intended route of administration. Particle size analysis and charge variant profiling further confirm that the product remains within defined quality attributes.

We also produce toxicology-ready batches under controlled conditions to support preclinical studies, ensuring consistent product characterization and safety.

Analytical Method Development

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Bioconjugate Formulation Development FAQs

What is bioconjugate drug formulation?

Bioconjugate drug formulation is the process of combining biologics, payloads, excipients, and formulation components to create a final biopharmaceutical product. The formulation process is not just about creating a drug that works; it’s about ensuring the drug reaches those who need it most – in a form that maximizes its therapeutic potential.

Why are solubility and stability important in bioconjugate drug formulation?

Solubility and stability are key factors; poorly soluble bioconjugate drugs can lead to reduced bioavailability, making them ineffective. Stability is crucial to maintain the drug’s efficacy over time, with methods like lyophilization or freeze drying used to preserve the drug under various conditions.

What role does personalized medicine play in formulation?

The rise of personalized medicine through an ever-increasing range of bioconjugate modalities means that formulation development must cater to specific patient needs. Through focusing on individual patient profiles, including age, health condition, and preferences, formulation scientists are developing more effective, and patient-friendly medicines.

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Let’s move medicine forward - Abzena

Let’s move medicine forward.

The treatments you’re developing right now can make a real difference for human health. We can work together to ensure your success, combining our deep scientific and technical know-how with your promising asset.

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