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The dismissal of all 17 members of the Advisory Committee on Immunization Practices has far-reaching impacts for the industry and beyond.

The industry is diversifying pipelines from traditional small-molecule drugs to embrace complex and exciting new modalities.

The partnership leverages the Hesperos organ-on-a-chip platform in the preclinical development of Psilera’s lead compound targeting the progressive neurological disorder for which treatment options are few.

Novel nucleases with diverse properties represent promising solutions, emphasizing their potential to overcome current limitations in genome editing and therapeutic delivery.

A continuous biomanufacturing platform can process higher/lower quantities of a drug as needed and allow manufacturers to respond to changing markets.

The increasing diversity and complexity of injectable drug products is driving innovation.

The rebranding to VeonGen marks a strategic shift to clinical-stage development, reflecting progress from platform innovation to human trials in gene therapy.

This paper highlights considerations based on risk that ensure ongoing success as well as improvement when applying cleaning and decontamination principles for biopharmaceutical cleanroom surfaces.

The facility is on the company’s Bedford, NH campus, where another existing building will be repurposed into a Development Center of Excellence.

Quality, stability, sustainability, and the increased and thoughtful integration of artificial intelligence are foremost in the minds of those on the leading edge of testing trends.

TriLink’s CleanCap capping technology, to which Quantoom will have access in the new partnership, has been used in the majority of all approved COVID-19 mRNA and saRNA vaccines.

Bringing in external expertise may be necessary when internal knowledge is lacking, but it is critical that any contract employee or consultant is comprehensively assessed to ensure the right person is employed.

Nicholas Giovannone of Regeneron explained the strategies behind overcoming re-administration challenges in a recap of his presentation at ASGCT 2025.

BNT327, a bispecific antibody targeting PD-L1 and VEGF-A, enters late-stage trials for lung and breast cancer with joint development by BioNTech and BMS.

Science is propelling advances and operational shifts in the bio/pharmaceutical industry.

In this recap of a poster presentation, Austin Daniels of Yokogawa Fluid Imaging Technologies explains how flow imaging microscopy can detect the amount and types of both subvisible and visible particles in samples not often detected by traditional methods.

Jerry Chapman of Redica Systems spoke with BioPharm International® about how artificial intelligence can assist in analyzing a clinical site to determine risk factors and spotlight potential future risks.

In discussions at INTERPHEX 2025, company representatives seized upon several common themes, most notably safety, sustainability, and the increasing utility of automation.

Biocon Biologics’ Yesintek demonstrated comparable safety and efficacy to the originator project, according to clinical data from a trial program.

Global scale-up requires developing replicable processes that work the same no matter where they are performed. This can be accomplished with smart factories that utilize fully automated manufacturing platforms.

Funding will support the company’s efforts to refine its proprietary glycan-engineering platform, expand its scientific and operational team, and advance preclinical studies of its engineered biologics.

BioPharm International® spoke with Oury Chetboun, CEO of Seekyo Therapeutics, to get his perspective on what impact new modalities and technology innovations are having on biopharmaceutical development.

Sanofi is acquiring Vigil Neuroscience, a biotech firm focused on novel neurodegenerative disease therapies, to boost its early-stage neurology pipeline.

The company’s presence at ASGCT included not only a booth on the show floor, but also one oral and nine poster presentations.

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.