05.05.25 -- What CDMOs Wish Biotechs Knew Before Submitting An RFP

Discover the statistical analysis results based on several DoE studies for the reduction of hcDNA and pDNA levels in a lentiviral vector (LVV) platform process.

Better understand the intricacies of AAV triple transfection and how advances in vector production and cell line optimization are enhancing gene therapy.

To prevent path-to-market setbacks, it is critical to develop a CMC strategy that proactively identifies scientific and compliance gaps, as well as mitigates risk.

For any biotherapeutic in development today, a critical element in achieving commercialization is reducing manufacturing risk.

This article, the first in a two-part series, focuses on the initial stages of product development — specifically, how to move from candidate selection to a Phase 1 IND application.

We developed a proprietary suspension HEK293 clone (AC001.230) with improved productivity for 7 of 10 AAV serotypes versus 293F cells.

A comprehensive Quality Risk Analysis and Control Strategy is built on five key pillars, each playing a vital role in ensuring that every final product meets the highest safety and efficacy standards.

Learn how pharmaceutical and biotech companies can leverage cutting-edge technology to bring transformative gene therapies to market, making treatments more readily available to patients worldwide.

Venkata Indurthi, Ph.D., discusses key upstream and downstream factors in RNA drug substance manufacturing.