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Product Characterization and Analytical Development Services for Biologics

BioReliance® analytical development services

Orthogonal approaches to product characterization support better understanding of your asset's performance, safety, and the manufacturing processes for Drug Substance (DS) and Drug Product (DP). Identity, purity (including process- and product- related impurities), strength, and potency should be considered collectively to inform the best decisions about: Where and how to act, setting specifications, and understanding performance. A subset of approaches should move into Analytical Development to formalize assays to support testing under GMP required for Critical Quality Attributes (CQAs) defined by ICH Q6B.

It is important to recognize that all modalities and processes are different, but the attributes defining quality are consistent and must be understood and monitored.

Connect with an expert

We support product characterization, analytical development, and analytical validation across modalities:

ADC Product Characterization

With ADCs it is important to look beyond drug-to-antibody ratio (DAR). Understanding how post translational modifications and conjugation may affect binding and potency is an important consideration that affects internalization and ultimately, potency.

mAb Product Characterization

How well do you understand the structure- function relationship with your molecule? With mAbs, it is important to understand binding performance, covalent modifications (post translational modifications and/or unintentional modifications) and how those factors affect performance.

Viral and gene therapy product characterization and analytical development
AAV Analytical Development

AAV therapies are complex and present unique challenges to monitor quality and performance. These activities require careful planning and management of orthogonal techniques (e.g., analytical, structural and molecular). Breadth of capabilities and coordination are key to success. 

Characterization – modality agnostic capabilities, modality specific solutions

It is imperative to understand product and process consistency and mitigate risk as related to safety and efficacy. This is defined by structure/function relationships and the primary attributes: Identity, purity, and potency. We employ both classic and progressive techniques to evaluate these ICH Q6B driven CQAs. This includes, but is not limited to:

  • Liquid chromatography (RPLC, HIC, SEC, IEX, UPLC) and electrophoretic methods (CE, CE-SDS, cIEF) using multiple detection modes
  • Mass spectrometry approaches
  • Binding e.g., ELISA, surface plasmon resonance (SPR), flow cytometry, cell-based assays, and molecular approaches

Analytical Development – modality agnostic capabilities, modality specific solutions

To support testing for clinical use, assays must be performed under GMP conditions, requiring phase appropriate, fit for purpose validation. A subset of the approaches used for characterization are amenable to this transition and should confirm specifications regarding CQAs as defined by ICH Q6B.

Choosing the right partner for your biologics analytical development

Partner with us for:

  • Early phase development to avoid costly pitfalls that require additional time, resources, and funding
  • Reliable data to help expedite product quality decisions at vital stages of development
  • Scientific experts and regulatory guidance to move your therapy from concept to clinic with confidence
Related Applications
Monoclonal Antibody Manufacturing
Monoclonal antibody manufacturing is a highly templated approach used to produce mAb-based immunotherapies. Robust, scalable process solutions are required at every step to ensure high therapeutic concentration and process safety, while meeting speed-to-market and cost containment concerns.
Antibody-Drug Conjugate (ADC) Manufacturing
Antibody-drug conjugation (ADC) technology uses monoclonal antibodies (mAbs) to deliver potent, highly active pharmaceutical ingredients (HPAPIs) to targeted cells. Learn about processes and areas of expertise required to advance your ADC to market.
Gene Therapy Manufacturing
Growing use of gene therapies is driving rapid innovation in an evolving global market. Manufacturers bringing new gene therapies to life face complex challenges, requiring an experienced partner capable of integrating vector manufacturing, testing, safety, process development, and regulatory compliance.
Cell Therapy Manufacturing
Introducing a new cell therapy demands optimal performance in upstream and downstream processing, process development, testing, and manufacturing. World-class products and partners are critical to success, speeding advancement of therapeutics that are effective, safe, and affordable.
Vaccine Manufacturing
From early phase development, through downstream purification to large scale vaccine production: learn more about vaccine process development and application expertise.
Related Services
Antibody drug conjugates CTDMO services
The goal of this page is to illustrate the overarching offering of the ADC modality within our LSS services including related quality services as a comprehensive CTDMO page
mAbs CTDMO Services
The goal of this page is to illustrate the overarching offering of the mabs(monoclonal antibody) modality within our LSS services including testing as a comprehensive CTDMO page
Viral Vector CTDMO Services
Our viral and gene therapy manufacturing site in Carlsbad, California has produced over 1,000 batches of virus, meeting rigorous timelines for more than 20 years with a complete range of services, a state-of-the-art cGMP facility, and deep regulatory understanding.
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