Aligning mRNA Progress with Regulatory Streamlining
ASGCT 2025: Emerging Modalities for Oncology Treatments
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.
Viral Clearance & Viral Safety: Industry Trends & Key Events
With regulators embracing next-generation sequencing, how will the ICH Q5A(R2) guidelines reshape viral safety strategies for gene and cell therapies?
REGENXBIO Releases Schedule of Its ASGCT Oral Sessions and Poster Exhibits
The company has had abstracts accepted for three oral presentations and five posters.
Novel Modalities Spur Shift in Outsourcing Processes and Partnerships
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.
FDA Appoints New Director of CBER
Dr. Vinay Prasad, MD, MPH, a hematologist-oncologist, has been chosen to lead the Center for Biologics Evaluation and Research at FDA.
Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing
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.
The Challenge of Market Uptake for Biosimilars
As more originator biologics lose patent exclusivity in the next decade, a healthy biosimilars pipeline is necessary but requires market support.
Automation Advances for Cell Harvesting in Biomanufacturing
Although automation is increasingly adopted in biomanufacturing, challenges remain in implementing it at the cell harvesting step.
Sustainability by Design in the Context of Bioprocess Development
Incorporating sustainable practices into process designs as early as possible ensures optimal performance.
Circio to Present Poster on CircRNA In Vivo Data at ASGCT 2025
The company hopes that its proprietary circVec technology platform will become a gold standard for nucleic acid and viral therapeutics.
AAPS National Biotechnology Conference 2025: AAV Vector Production
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.
AAPS National Biotechnology Conference 2025: Accelerating Formulation of High-Concentration Biologics
BioPharm International® spoke with Lun Xin, associate director at WuXi Biologics, about how automation can accelerate and improve the formulation of high-concentration biologics.
AAPS National Biotechnology Conference 2025: 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.
The Use of Analytics in Biopharmaceuticals: An Introduction
This article provides an overview and introduction to the use of analytics in biopharmaceutical development and manufacturing.
Authentic Intelligence: Finding Diverse Talent in the Age of AI
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.