Accelerating Biosimilar Development using Octet® BLI

Achieve more cost-effective results by enhancing biosimilar assessment throughout upstream and downstream processes through the application of kinetic screening and other innovative methodologies.

Register Free: https://www.biopharminternational.com/bp_w/accelerating-biosimilar

Event Overview:

There is a continuing need for affordable drugs that increase the number of treatment options and access to lifesaving medications whilst potentially lowering health care costs. Biosimilars are biological medicines that are highly similar to an already approved biopharmaceutical drug. Recent years have seen an increase in competition for blockbuster biologics due to the original product's patent expiration, which allows biosimilars be manufactured.

Biosimilarity needs to be demonstrated throughout the entire upstream and downstream production process and the use of standard analytical methods, such as ELISA and HPLC, to screen all potential candidates can be prohibitive; as a result, an alternative high-throughput analytical approach is desirable.

The Octet® R and RH BLI systems can be used at multiple points upstream and downstream to assess several key attributes including target binding characterization, potency, Fcg receptor binding, glycan screening and assessment of impurities and host cell proteins along with other CQA, which helps simplify the development process.

• This webinar describes how throughput can be increased even further on the Octet® R series by use of a single concentration of analyte in a kinetic screen.
• Anti- TNFα antibody Humira was used to determine an optimum single analyte concentration that allowed accurate kinetic rate constants to be determined without the requirement of multiple analyte concentrations.
• The single analyte concentration was used to perform a kinetic qualification to determine inter- and intra-assay variability when assessing the Fcg receptors CD16a, CD64 and its antigen, TNFα.
• Biosimilar column elution fractions of adalimumab (a Humira biosimilar) were then assessed and compared to Humira using a single concentration kinetic screen and any effects of different column elution buffers assessed.
• The single analyte concentration kinetic screens approach allows multiple attributes and CQAs to be rapidly assessed in a single assay enabling users to triage molecules with desired characteristics so that only optimal ones are progressed downstream.

Key Learning Objectives:

• Learn how the high-through-put Octet instruments and reagents can be used to design assays that rapidly characterize multiple attributes of antibody binding for biosimilarity assessment.
• Learn how to design and utilize single analyte concentrations for relevant kinetic screens.
• Learn about new features on the Octet instrument for stability indicating assays including potency assessment

Who Should Attend:

• Anyone that is working on biosimilars or large antibody libraries that want to assess kinetics and affinity of multiple analytes or ligands using a rapid and facile method.

Speaker:

Dr. Stuart Knowling
Senior Application Scientist
Sartorius

Dr Stuart Knowling is a Senior Application Scientist and has over a decade of experience in biophysics and has headed up multiple projects for drug companies in preparation for submissions. Combined with almost twenty years’ worth of experience in biophysical protein and nucleic acid production and characterization. After research appointments at both University College San Diego and the Scripps Research Institute, La Jolla, Stuart adapted his knowledge of biophysical techniques to meet the growing demands of the Biosimilars market.

Stuart has initiated and developed multiple BLI and SPR assay formats to characterize biosimilar monoclonal antibody-based therapies as part of larger similarity studies. Stuart also has a strong focus on developing target binding assays across a range of protein and non-protein molecules to meet the needs of his clients at all stages of submission to regulatory bodies.

Stuart is highly active in presenting his work across the globe and is the lead author on multiple documents and continues to advance Octet® BLI and SPR so that users can generate high quality data in the simplest manner possible.

Register Free: https://www.biopharminternational.com/bp_w/accelerating-biosimilar