Search results for " IND"
Article
Scaling Up Novel Therapies
Within the past decade, however, the industry has achieved significant improvement by adopting technologies that allow more predictable outcomes, says Alex Chatel, product manager at Univercells. Bior…
Article
FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
Clinical development is crucial, but industry needs to have “manufacturing under control,” Marks observed.
More support
FDA’s Regenerative Medicine Advanced Therapy (RMAT) program can help exp…
Article
Understanding Validation and Technical Transfer, Part 3
This third article in a three-part series (1,2) dealing with validation and technical transfer in the biopharmaceutical industry discusses validation of a non-traditional biopharmaceutical process, l…
Article
Transformative Medicines Challenge FDA and Manufacturers
FDA reports that some 40 companies are developing CAR-T technologies for multiple indications and that it is monitoring more than 600 active investigational new drug applications (INDs) related to gen…
Article
Continuous Processing for the Production of Biopharmaceuticals
By Anurag Rathore, Nikhil Kateja, Harshit Agarwal, Abhishek Kumar Sharma
Benefits of continuous processing have been widely demonstrated by a variety of manufacturing industries. With the growing …
Article
Viral Clearance Challenges in Bioprocessing
Processes with fewer purification steps present a challenge to virus clearance, however, because higher removal claims are expected with individual unit operations. “Access to high titer virus prepara…
Article
HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
Monoclonal antibodies (MAbs) are an important class of therapeutic proteins in biotechnology and have been developed to treat a variety of indications to fill significant unmet medical needs.1 MAbs ge…
Resource
The Development of Therapeutic Monoclonal Antibody Products
This report provides a roadmap for the development of a monoclonal antibody product from initial discovery through the filing of an Investigational New Drug Application (IND) or Investigational Medi…