BioPharm International

BioPharm International magazine combines the scientific and business aspects of biopharmaceutical research, development, and production. We offer hands-on, peer-reviewed technical insights designed to help biopharmaceutical experts work more efficiently in their roles.

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EG 427 Presents Two Posters at ASGCT 2025

1 day ago | biopharminternational.com | Patrick Lavery

The France-based genetic medicines developer EG 427 has provided details on its two posters exhibited on the first night of the 28th annual meeting of the American Society of Gene and Cell Therapy (ASGCT), running from May 13–17, 2025 in New Orleans (1). Vector technology proven effectiveData presented by the company in the posters focused on the HSV-1 genome and EG 427’s role in developing non-replicating HSV-1 (nrHSV-1) vector technology for neurology applications (1).
Genentech Plans North Carolina Manufacturing Facility, Expanding Roche’s US Footprint

3 days ago | biopharminternational.com | Patrick Lavery

The biotechnology company Genentech, a member of the Roche Group, announced on May 12, 2025, that it will invest more than $700 million in a new, state-of-the-art drug manufacturing facility in Holly Springs, NC, Genentech’s first facility to be built on the East Coast of the United States (1). The Roche Group has several other East Coast properties outside the Genentech brand.
REGENXBIO Releases Schedule of Its ASGCT Oral Sessions and Poster Exhibits

1 week ago | biopharminternational.com | Patrick Lavery

REGENXBIO, a Rockville, Md.-based clinical-stage biotechnology company, is announcing its slate of oral and poster presentations to be made at the American Society of Gene & Cell Therapy (ASGCT)’s 28th annual meeting, which will be held in New Orleans from May 13–17, 2025 (1).
Novel Modalities Spur Shift in Outsourcing Processes and Partnerships

1 week ago | biopharminternational.com | Patrick Lavery

So far in 2025, BioPharm International® has taken a look at outsourcing in terms of the steps in the processes of developing and producing biologics, analytical technologies that can best align with process monitoring and optimization, and how newly-formed partnerships are helping to ease capacity shortages (1–3). At the same time, innovation continues to push forward, with sustainability and cost savings near the top of the list of priorities (4,5).
FDA Appoints New Director of CBER

1 week ago | biopharminternational.com | Susan Haigney

FDA Director Martin Makary announced on May 6, 2025 that he has appointed Dr. Vinay Prasad, MD, MPH as the director of FDA’s Center for Biologics Evaluation and Research. Prasad is a hematologist-oncologist and was previously a professor in the department of Epidemiology and Biostatistics at the University of California San Francisco (UCSF).
Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing

1 week ago | biopharminternational.com | Patrick Lavery

United States President Donald Trump has signed an executive order containing several directives to FDA and the Environmental Protection Agency (EPA), aiming to reduce regulatory barriers and restore a robust domestic manufacturing base for prescription drugs (1).
Circio to Present Poster on CircRNA In Vivo Data at ASGCT 2025

1 week ago | biopharminternational.com | Patrick Lavery

Norway-based Circio Holding (Circio) plans to present new and strengthened circular RNA in-vivo data in a poster exhibit at the 2025 American Society of Gene and Cell Therapy (ASGCT) meeting in New Orleans, which will be held May 13–17, 2025 (1).
Automation Advances for Cell Harvesting in Biomanufacturing

1 week ago | biopharminternational.com | Feliza Mirasol

Cell harvesting is an important step in the manufacture of biologic modalities, and one area where automation technologies can play a major role. Traditionally, cell harvesting has relied heavily on centrifugation and depth filtration, both labor-intensive techniques that are prone to variability. But recent advances in automation technologies have significantly improved the efficiency, scalability, and consistency of cell harvesting to enable more streamlined bioprocessing workflows.
AAPS National Biotechnology Conference 2025: AAV Vector Production

1 week ago | biopharminternational.com | Susan Haigney

Adeno-associated virus (AAV) vectors are commonly used for gene therapies, according to Noah Kopcho, field application scientist at Gyros Protein Technologies. AAV vectors come with challenges in productions, however. “Namely, compared to other vectors, AAV often has lower titers,” says Kopcho. “This can present problems with scalability. During the production and purification workflow, there are several different contaminants that need to be kept in mind, and purity is often essential.
AAPS National Biotechnology Conference 2025: Accelerating Formulation of High-Concentration Biologics

1 week ago | biopharminternational.com | Susan Haigney

The use of automation in the protein industry is relatively new, according to Lun Xin, associate director at WuXi Biologics, with automated analysis, automated upstream, and automated downstream production becoming more common. “Where this industry is going is automation, particularly coming down to the drug product formulation [and] development,” says Xin. “This [is] because we need to understand the protein’s properties and then screen different types of buffer pH exceptions.