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In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss how to address an FDA warning letter citation for a failure to establish a quality control unit.

Mirai Bio and Thermo Fisher partner to integrate AI-driven design with CGMP manufacturing, aiming to streamline development of genetic medicines.

A letter of intent has been signed by the two companies for supply of artificial platelet raw material.

A late-breaking poster presented at ASGCT 2025 described the enhanced central nervous system transduction and safety of the vector.

A pediatric patient with a rare genetic disorder safely received a personalized CRISPR therapy, marking the first known case of a personalized CRISPR-based medicine administered to a single patient.

Tevard's tRNA therapy appears to restore full-length dystrophin and motor function in a Duchenne muscular dystrophy model, showing promise for nonsense mutation treatments.

The poster presentations contain data highlighting the company’s role to date in developing non-replicating HSV-1 technology for use in neurology.

The company’s technology was used to create CAR-T cells that demonstrated the expression of complex CARs in a single DNA donor.

According to the White House, the order builds on actions taken in the president’s first term to reduce price disparities domestically.

The proposed $700 million, 700,000-square-foot space will support the companies’ future joint portfolio of next-generation obesity medicines.

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

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.

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.

BioPharm International® spoke with Alexander Seyf, CEO and co-founder of Autolomous, about the impact geopolitical changes in Europe might have on the bio/pharmaceutical industry.

While global harmonization exists, there are still differences between the US and European GMP requirements that manufacturers should know, says Siegfried Schmitt, PhD, vice president, Technical at Parexel.

Aviva Capital Partners and developer Socius are investing £1 billion in a 12-acre site to be located at the London Cancer Hub next to The Institute of Cancer Research, London and The Royal Marsden NHS Foundation Trust’s Sutton site.

The bio/pharma industry is evolving with intention, intelligence, and a growing sense of shared purpose.

The company’s intent is to establish Merck Wilmington Biotech as the future United States home for producing Keytruda for US patients.

Among the new data the company plans to show in its presentations is the successful, repeated dosing of an mRNA-LNP in monkeys.

Black Hawk’s subsidiary, BH Merger Sub, will merge with Vesicor as part of the agreement.