pDADMAC Flocculation Reagent Studies

Pre-treatment Process Optimization for Harvest Using Inline PAT

Program Overview

  • Case Study 1: Acid titration to precipitate soluble impurities
  • Case Study 2: Characterizing Calcium Phosphate coagulation and pDADMAC as a polymer flocculant reagent to improve impurity clearance and filtration efficiency
  • How real-time, in-situ particle system characterization correlates directly to harvest parameters such as filter capacity and impurity clearance
  • How real-time, in-situ particle system characterization can accelerate process understanding and reduce overall resource demands

Understanding particle system behavior and effect on quality during bioprocess harvest is a challenge. As a result, many issues stemming from over-burdened unit operation capacity, reduced processing efficiency, and excess impurities will carry over into other unit operations. Inline, real-time monitoring of particle systems can provide direct, actionable process information that other techniques lack. Inline particle measurements that are continuous, data-rich, and directly correlate to process outcomes also enable prediction and feedback control of harvest processes.

In this webinar, acidic precipitation of nucleic acids in cell culture broth is evaluated to improve filtration and pre-chromatography impurity clearance. Alternative methods of HCP clearance and filtration outcomes with different flocculation reagents are also evaluated. In each process, offline particle analysis and filtration throughput studies alone are insufficient to fully characterize the processes. Inline particle characterization is required to understand clearance mechanisms and optimize harvest.

Target Audience

Bioprocess development scientists, engineers, and technicians, persons working on harvest operations in bioprocesses, principals, managers, and directors supporting bioprocesses.

About the Presenter

tyler gable

Tyler Gable, Ph.D.

Global Biopharma and Biotech Market Development Manager, METTLER TOLEDO

Dr. Tyler Gable is the Market Development Manager for Biopharmaceuticals at METTLER TOLEDO. Dr. Gable has lead inline PAT development across upstream, harvest, downstream, and formulation workflows for biopharmaceutical bioprocessing. Dr. Gable has 5 years of GMP and QC/QA experience prior to his bioprocessing roles. Dr. Gable received his Ph.D. in Molecular Medicine, designing RNA blood diagnostics and RNA gene therapies applied to lung cancers.