BioPharm International® spoke with Ryan Larson, PhD, SVP, Head of Research at Umoja BioPharma about how emerging modalities in oncology treatments, including cell therapies, are evolving.

With regulators embracing next-generation sequencing, how will the ICH Q5A(R2) guidelines reshape viral safety strategies for gene and cell therapies?

The company has had abstracts accepted for three oral presentations and five posters.

While a one-stop shop still has its advantages, sponsor companies and CDMOs are starting to see each other not as transactional relationships, but true partners with a common goal of getting drugs to patients faster.

Dr. Vinay Prasad, MD, MPH, a hematologist-oncologist, has been chosen to lead the Center for Biologics Evaluation and Research at FDA.

The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.

As more originator biologics lose patent exclusivity in the next decade, a healthy biosimilars pipeline is necessary but requires market support.

Although automation is increasingly adopted in biomanufacturing, challenges remain in implementing it at the cell harvesting step.

Incorporating sustainable practices into process designs as early as possible ensures optimal performance.

The company hopes that its proprietary circVec technology platform will become a gold standard for nucleic acid and viral therapeutics.

BioPharm International® sat down with Noah Kopcho, field application scientist at Gyros Protein Technologies, to talk about the challenges in the production of AAV vectors.

BioPharm International® spoke with Lun Xin, associate director at WuXi Biologics, about how automation can accelerate and improve the formulation of high-concentration biologics.

BioPharm International® spoke with Lun Xin, associate director at WuXi Biologics, about high-concentration biologics and some of the biggest challenges associated with their formulation.

This article provides an overview and introduction to the use of analytics in biopharmaceutical development and manufacturing.

The pandemic made it daunting for companies to retain talent and then find it anew, but just as that cloud is lifting and workforce diversity is being embraced, AI beckons as a new challenge.