From The Stage

Determining the Efficacy of Biologics Using Potency Assays Under Good Manufacturing Practice Regulations

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / Cell-Based Assays, CRO Selection

Cell-based potency assays, the central tool used to measure drug efficacy during potency testing, allow scientists to see how a particular dose of a drug will react in a given biological system. We discuss how an ideal CRO partner should approach potency assay design and validation under GMP.

Strategic Bioanalytical Partnerships for the Win-Win-Win

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / Cell-Based Assays, CRO Selection

For bioanalytical CROs, it is of critical importance to build an internal team capable of meeting their pharmaceutical and biotech customers’ drug development goals. However, many overlook the benefits of strategically aligning with external partners – those organizations that can add value to the CRO’s offerings, supplementing their solutions and services to make them more comprehensive and attractive to customers.

Evaluating the Immunogenicity of Antibody-Drug Conjugates

Dr. Corinna Fiorotti
Posted by Dr. Corinna Fiorotti / / Cell-Based Assays, Immunogenicity

Antibody–drug conjugates (ADCs) represent an innovative therapeutic approach that provides novel treatment options and hope for patients with cancer and infectious disease. In fact, ADCs are quickly becoming one of the fastest growing classes of oncology therapeutics in the pipelines of many pharmaceutical companies. The design behind ADC-based treatments – leveraging the specificity of a monoclonal antibody (mAb) to deliver a potent small-molecule cytotoxic drug to the intended pharmacological target while reducing the exposure of normal cells – seems relatively simple conceptually. However, ADCs have presented more challenges than developers…

Applying Cell-Based Assays, Part 2: Potency Testing for Lot Release Under GMP

Dr. Jeff Patrick
Posted by Dr. Jeff Patrick / / Cell-Based Assays

In our blog discussing the use of cellular assays for neutralizing antibody (NAb) detection, we touched on the value that bioassays offer through their ability to closely mimic the effects that a biotherapeutic drug product will have on the body without the use of animals in the study. This is what makes cell-based potency assays the choice for measuring and validating the therapeutic activity of a drug product within prescribed ranges of safety, purity, and strength (potency), which is a requirement for regulatory submission and both clinical and commercial lot…

Applying Cell-Based Assays, Part 1: Neutralizing Antibody (NAb) Detection

David Rusnak
Posted by David Rusnak / / BioAgilytix Insight, Cell-Based Assays

Protein-based biologic agents have the potential to induce a variety of immune responses from the body, ranging from very minor to life threatening. One such adverse immune response is generation of neutralizing antibodies (NAbs), which can bind to the biotherapeutic drug product administered and prevent it from performing its intended biologic function, in turn negatively impacting the product’s efficacy and safety profile. While standard immunoassays can be used to detect drug-specific antibodies including NAbs, they cannot distinguish NAbs from any other antibodies found. So what can we use to determine…

Assay Design for Immunogenicity Testing: Cell-Based or Ligand Binding?

David Rusnak
Posted by David Rusnak / / Cell-Based Assays, Immunogenicity

Unlike small molecule drugs, large molecule therapeutics face a high chance of detection by the immune system, and are therefore more apt to trigger alarms. The resulting immune responses can range from largely benign to life threatening – which is why immunogenicity testing has become a critical requirement in the biologics development process. But, the development and implementation of such assays can be technically challenging, and this is causing differing industry opinions around the use of cell-based functional assays vs. non-cell-based competitive ligand binding assays for NAb detection. The Turning…

What’s Your System for Cell-Based Assay Method Selection?: Factors in Assessing the Most Advantageous Model for Your Needs

David Rusnak
Posted by David Rusnak / / BioAgilytix Insight, Cell-Based Assays

Cell-based assays are a key component in the creation of new medicine, from early target and drug discovery efforts through clinical trial and manufacturing support. Complex biochemical processes in the body can often be investigated and understood in cell-based model systems, and there is a near limitless variety of cell-based assay platforms that can be developed. Clinical pharmacology studies are a critical part of demonstrating this ‘biosimilarity’, and provide the data for the biosimilarity in drug exposure between the biosimilar and the originator / reference product to confirm no clinically…