Manufacturing remains big challenge for cell and gene therapy industry

October 17, 2022

The time has never been more critical for the industry to accelerate the development and manufacturing of cell and gene therapies to bring more treatments to more patients, contends Eric Blair, chief commercial officer for Andelyn Biosciences.

Science Advisory Board spoke with Blair at last week's 2022 Cell & Gene Meeting on the Mesa in Carlsbad, CA, about the challenges of manufacturing to meet growing demand in the sector and the Biden administration's investment of more than $2 billion designed to enable the U.S. to harness the full potential of biotechnology and biomanufacturing.

"It is a very good start," Blair said. "We, at Andelyn, are trying to take a leadership position to work with governments, nonprofits, as well as various agencies and partners across the gene therapy and cell therapy markets so that we can do this quicker. The quicker we can do it, the quicker we can save lives."

Andelyn Biosciences, a biopharma contract development and manufacturing organization (CDMO) that supports customers from preclinical concept to commercialization, has successfully completed more than 400 current good manufacturing practice (cGMP) clinical batches and over 2,000 research-grade batches.

As a CDMO, the company offers capabilities spanning preclinical R&D, viral vector process and analytical development, small to large scale cGMP manufacturing up to 2000L, as well as fill/finish and quality release testing. The company's R&D laboratories manufacture research grade and toxicology grade viral vectors.

A recent report in Cell and Gene Therapy Business Outlook (CGTBO), a sister publication of Science Advisory Board, detailed how viral vector trends are impacting the nascent cell and gene therapy industry. Currently, the industry needs 2 to 3 billion liters of bioreactor capacity to meet the current demand for viral vectors. However, production cannot keep up with demand.

"That's exactly the reason why we have decided to make the investment," Blair said, noting that Andelyn has just opened its third 250,000-sq-ft clinical and commercial GMP facility in Columbus, OH, that was built to support high-quality manufacturing.

Watch this video to learn more.

FDA biologics chief outlines ways to remove barriers to cell and gene therapies
At this year's Meeting on the Mesa, the U.S. Food and Drug Administration’s top biologics regulator said the use of a “cookbook” for developing cell and...
Cytiva acquires Cevec Pharmaceuticals to boost cell line development
Life sciences company Cytiva has acquired Cevec Pharmaceuticals for an undisclosed amount, which will further strengthen Cytiva's cell line development,...
Demand for viral vectors seen outpacing capacity growth despite investment surge
The growth in demand for viral vectors is outpacing a push to add capacity, leading to predictions that the current supply shortage will continue despite...
Federal funding of $2B to support biotechnology and biomanufacturing
The White House announced on Wednesday federal funding of more than $2 billion to advance President Joe Biden’s executive order intended to enable the...

Copyright © 2022

Last Updated 10/17/2022 12:26:42 PM