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.

CAR T-Cell Therapy: Changing the Way Cancer is Treated

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / BioAgilytix Insight, Immuno-oncology

One of the most promising types of immunotherapy uses adoptive cell transfer (ACT). While all types of ACT are in their early days of development relatively speaking, one method showing great potential is chimeric antigen receptor T-cell therapy, or CAR-T.

A Dose of Pharma and Biotech News: March 7, 2018

Jim Datin
Posted by Jim Datin / / BioAgilytix Insight, Industry Update

BioAgilytix is committed to keeping on the pulse of bioanalytical innovation across the pharmaceutical and biotechnology industries. To that end, we’d like to share some of the industry headlines we’ve been most interested in recently.

Supporting Biosimilar Assessment: Best Practices for the Development and Validation of Neutralizing Antibody Assays

Dr. Dominique Gouty
Posted by Dr. Dominique Gouty / / Biosimilars, Immunogenicity

Immunogenicity assessments are a critical component to determining the comparability of an originator drug and a biosimilar. It is necessary to determine both neutralizing and non-neutralizing antibody incidence for an originator drug and a biosimilar, and understand the immunogenicity’s impact on PK results as well as its association with adverse events.

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.