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Manufacture

Manufacture Advanced Medicine

This Week’s CGT News: Vinay Prasad Becomes New Director of FDA CBER

| 3 min read

Our latest news roundup reports on Vinay Prasad’s appointment, a personalized gene therapy for a baby with an ultra-rare condition, and more.

Manufacture Advanced Medicine

CGT Manufacturing Capacity: Battle of the CDMOs

| 2 min read

Capacity has been built for cell and gene therapy manufacturing, but will demand keep pace? CDMOs may face a battle for survival.

Manufacture Contract Development Services

Streamlining Biologics from IND to Commercial Scale with Continuous Manufacturing

| Nick Hutchinson | 4 min read

When it comes to continuous cGMP biomanufacturing, Just – Evotec Biologics’ J.DESIGN platform integrates data analytics and continuous manufacturing

Manufacture Advanced Medicine

Characterizing CAR T Cells

| Stephanie Vine | 2 min read

Researchers develop new approach that could help with CAR T manufacturing.

Manufacture Clinical Trials

This Week’s Biopharma News: AstraZeneca Cans Phase III Trial

| Stephanie Vine | 3 min read

Our latest news roundup reports on Amgen’s $900 million investment, EMA’s re-examination of donanemab, philanthropy at Sanofi, and more.

Manufacture Advanced Medicine

Inhalable Gene Therapies? Here’s How They Could Work

| Stephanie Vine | 5 min read

Scientists explain how inhalable gene therapies are being developed to treat cystic fibrosis.

Manufacture Advanced Medicine

Gene Therapy Research Roundup: Gene Circuits and Controlling Capsids With Machine Learning

| 3 min read

We look at some of the latest studies and research announcements focused on improving gene therapy.

Manufacture Advanced Medicine

Kite, CAR Ts, and Access for Patients

| Stephanie Vine | 9 min read

We sat down with Kite’s Cindy Perettie to talk about access to CAR Ts.

Manufacture Facilities

FUJIFILM Diosynth and Regeneron Sign 10-Year, $3 Billion Manufacturing Agreement

| Stephanie Vine | 2 min read

FUJIFILM Diosynth to manufacture biologics for Regeneron at new facility in Holly Springs, North Carolina.

Manufacture Advanced Medicine

Advancing AAV Manufacturing Quality

| Efrain Guzman | 3 min read

Overcoming the limitations of the triple plasmid transient transfection method for AAV manufacturing.

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May Issue of The Medicine Maker