Regulatory Requirements for Biologic Drug Development

Article

Developing and manufacturing a therapy in a regulated environment demands careful adherence to quality practices.

In this Expert Interview with BioPharm International, Steven Lynn, executive vice-president, pharmaceuticals, Regulatory Compliance Associates, shares insight on regulatory guidances, potential stumbling blocks on the development pathway, strategies to navigate the regulatory approval process, accelerated review applications, and maintaining quality standards.

Recent Videos
Buy, Sell, Hold: Cell and Gene Therapy
Buy, Sell, Hold: Cell and Gene Therapy
Related Content
Communication between the manufacturing plant and retail stores. | Image Credit: © Cagkan - © Cagkan - stock.adobe.com

Circio and Certest to Collaborate on LNP Formulations

Feliza Mirasol
November 21st 2024
Article

The companies will collaborate to create and test circVec DNA–LNP formulations for use in potential therapeutic applications.

Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Felicity Thomas
June 25th 2024
Podcast

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.

Science laboratory test tubes, laboratory equipment | Image Credit: © BillionPhotos.com - © BillionPhotos.com - stock.adobe.com

EMA’s CHMP Gives Positive Opinion for Use of Lecanemab in Early Alzheimer’s Disease

Felicity Thomas
November 16th 2024
Article

CHMP has granted Eisai Europe and Biogen a positive opinion for the use of their monoclonal antibody therapy in treating early Alzheimer’s disease.

Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail

Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail

Felicity Thomas
May 28th 2024
Podcast

In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.

Communication between the manufacturing plant and retail stores. | Image Credit: © Cagkan - © Cagkan - stock.adobe.com

Avantor Sees Future of Opportunities with Growing Development of Next-Gen Biotherapeutics

Feliza Mirasol
November 15th 2024
Article

Executives at Avantor talk about the future of the biopharmaceutical industry and the anticipated impact that a wave of next-generation biotherapeutics will bring.

Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - © Artur - stock.adobe.com

MD Anderson Launches Cell Therapy Institute

Susan Haigney
November 11th 2024
Article

The new Institute for Cell Therapy Discovery and Innovation will utilize expertise to develop cell therapies for cancer, autoimmune diseases, and infections.