In response to the evolving extracellular vesicle (EV) landscape and rising interest in EV therapeutics, a new tier of qEV columns is now available: GMP-ready qEV columns.
This development is intended to support qEV customers with a therapeutic focus or those otherwise working with or aiming to work with EVs in an in vivo setting. These GMP-ready qEV columns can be produced on request under conditions designed to improve the control of bioburden and endotoxin levels, with Certificates of Analysis available to demonstrate that each batch meets specified criteria.
The rationale for developing GMP-ready qEV columns
With their innate properties and their potential as drug delivery vectors, EVs are attractive as therapeutics. Naturally, qEV customers generating EVs for administration in vivo face more stringent regulations than those working in vitro. One of these critical sets of standards is the ‘’current Good Manufacturing Practices”. cGMP is a set of regulations and guidelines established by regulatory authorities, such as the U.S. Food and Drug Administration (FDA) and similar agencies in other countries, to ensure the quality, safety, and efficacy of medicinal products.
To date, the US FDA has not granted approval for any EV therapeutic from mammalian cells, but it is anticipated that such approvals will be granted in the near future. In anticipation of this, Izon is actively taking steps to make our qEV columns available to the biologics sector. To achieve this goal, we are committed to meeting our customers' rigorous quality standards and complying with the manufacturing expectations set by regulatory authorities under cGMP.
While customers are still responsible for regulatory compliance and related risk assessments, the additional measures put in place for GMP-ready column production provide a good starting point for customers working in GMP environments.
What distinguishes GMP-ready qEV columns?
The distinction of GMP-ready qEV columns lies in their production process. GMP-ready qEV columns are manufactured in a way that minimises bioburden and endotoxin levels as much as possible.
Our new GMP-ready qEV columns are produced in an environmentally controlled cleanroom workspace along with additional cleaning procedures and new aseptic manufacturing protocols. There is also an additional quality control process to assess bioburden and endotoxin levels for each batch, with strict targets which must be met for batch release.
Learn more about the production of GMP-ready qEV columns
The process methods and controls underlying GMP-ready qEV columns are described in a Regulatory Support File which is now available for download. GMP-ready qEV columns are made to order and can be requested using the same link, or by reaching out to your local Izon representative for a quote.
Interested in GMP-ready qEV columns? You can request a quote and access the qEV Regulatory Support File here.
