Bioconjugate & ADC Formulation Development - Abzena

Bioconjugate Formulation Development

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

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Robust formulation development for bioconjugates tailored to your needs.

Customized for your bioconjugate or antibody drug conjugate (ADC) development phase, Abzena will align your drug to 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 developing formulations for small and large therapeutic molecules such as peptides, proteins, monoclonal antibodies and antibody-drug conjugates (ADCs).

Our 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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A Customized Step-by-Step Approach

Abzena puts into play 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

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 commercial, 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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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. Through stress testing, forced degradation studies, and excipient compatibility assays, we identify optimal formulation conditions to maintain stability, extend shelf life, and that are appropriate for the desired 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 pre-clinical studies, ensuring consistent product characterization and safety.

Analytical Method Development

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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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