With a focus on speed and recognition that each of our partners’ needs is unique, we begin our collaborations by launching a thorough situation analysis that defines specifications, determines timelines, and sets strategy to achieve optimal results.
In simplistic terms, high affinity, high selectivity affinity ligands can be thought of as a lock-and-key model for biological recognition. Given the diversity across biologics, it is not possible to predict a priori which ligand type is better than others. However, it is known that a single ligand class or scaffold will not work every time. The cost of time and failing to develop a solution is unrecoverable.
To avoid this, Avitide applies its proprietary portfolio of AVIPure® ligand scaffolds (50+ to date) and library diversity (greater than 1E14), enabling a vast interrogation of different ligand sizes, shapes, conformations, and contact areas. The implementation of this extreme diversity enables delivery success rate and unrivaled affinity purification performance in the industry. Throughout ligand discovery stage, we quickly screen and arrive at optimal ligand candidates for each biomolecule focusing on affinity, stability, and manufacturability.
Following analytical characterization of ligand binding, elution kinetics, and selectivity, we deliver a data package to our partners and recommend lead ligands to transition to the resin development stage.
Once a subset of ligand candidates is selected, production is scaled up using methods appropriate for commercial resin manufacturing. We then produce hundreds of candidate resins for screening, evaluating a resin manufacturing DOE that takes into consideration ligands and ligand density, chemistry, matrix type (size and porosity), and linkers. We also evaluate affinity resin separation performance in relevant bioprocess feedstreams, establishing binding and elution conditions within each molecule’s stability profile and separation and operational conditions that achieve each of our partner’s resin specifications.
With the project complete, we conduct an onsite technology transfer of the resins, data, and protocols to our partner. We then collaborate, providing ongoing technical support wherever necessary, to ensure operational success. Our partners confirm our results and initiate further testing to nominate their preferred resin for commercial supply.
Custom affinity resins are available in pre-packed and pre-qualified OPUS® Columns for rapid GMP implementation as well as in loose resin formats.
OPUS® Columns allow you to progress from development to manufacturing scale in weeks, using pre-packed and pre-qualified chromatography columns.
ABOUT OPUS® COLUMNS
Repligen develops and manufactures products for the biopharmaceutical industry. We focus on the timely delivery of high quality, consistent and robust products, to ensure business continuity for our customers.
Avitide, a Repligen company, is an ISO 9001:2015 certified resin manufacturer and supplier of custom affinity purification resins based in Lebanon, NH. Redundancy is built into the manufacturing model across the U.S. and Europe, with multiple resin warehousing locations, multiple qualified resin production facilities, and multiple ligand production facilities.