Bioconjugate & ADC Regulatory Affairs & Support

Tailored and compliant solutions from credible experts.

Streamlining your program from early development to commercial, we deliver regulatory guidance and packages tailored to you and your molecule.

Contact Us

Ensuring compliance and a robust regulatory strategy, we develop phase-appropriate qualification, characterization, and analytical method validation strategies appropriate to your stage of product development and assist in the preparation of global filings.

Phase appropriate validation

We offer consolidated phase-appropriate validation packages with fit-for-purpose methods and robust de novo assays that stand up to regulatory scrutiny.

Ensuring conformance with ICHQ7, our scientists ensure cGMP compliance and the highest levels of efficiency without compromising product quality or patient safety.

Based on our decades of regulatory experience, we will provide the best strategy for your molecule, regardless of its phase. We are here to support all your regulatory needs.

Process characterization

Ensuring the robustness and repeatability of your process and consistent quality of product, we utilize design of experiment (DOE) studies to ensure your process is fully understood and documented to support successful regulatory submissions.

Saving time and ensuring scalability, we are committed to quality excellence and designing and delivering tailored solutions with patient safety in mind.

Our team has expansive experience and capability to consider your process requirements, developing a series of protocols and regulatory strategies tailored to your molecule and desired function.

Contact Us

Analytical methods

Bioconjugate & ADC Formulation Development - Abzena

Helping you meet regulatory and quality requirements, our experts provide guidance and design; execute; and document analytical method development, qualification, and validation programs to support even your most complex molecules.

Ensuring compliance throughout, we follow ICHQ2(R2) guidelines for method validation, delivering robust programs that meet your requirements.

Our analytical methods are adaptable to your needs and standards. Expert analytical teams are fully integrated into your project, giving you access to data quickly. Collaboration between our analytical, and process and formulation teams ensure the development and validation of robust phase-appropriate methods.

Analytical Method Development

Related Content

Process Track Record

We have developed hundreds of small molecules including high potency chemistry, payloads, linkers, payload-linkers as well as bioconjugation and Antibody Drug Conjugates (ADCs), giving us ...

Learn More

Technology Transfer

We utilize a comprehensive risk-based approach to ensure a successful technology transfer by capturing process knowledge throughout your program and incorporating any regulatory authority feedback ...

Learn More

Analytical Method Development

Your product development program will be accelerated by leveraging our extensive in-house capabilities, technologies, and knowledge to deliver methods tailored to your molecule of interest.

Learn More
Bioconjugate & ADC Analytical Method Development - Abzena

Let’s move medicine forward.

The asset you’re developing right now can make a real difference for human health. Let us apply our wealth of experience to accelerate and maximize its potential.

Contact Us