Susan Haigney

EMA’s CHMP recommended conditional marketing authorization for linvoseltamab to treat adults with relapsed and refractory multiple myeloma.

Sponsor companies and contract development and manufacturing companies must ensure that the suppliers they use are following sustainability guidelines to truly produce ‘green’ products.

Contractors are working with sponsor companies to establish and maintain sustainable manufacturing practices in pharma.

Contract manufacturers have special expertise in the characterization and validation of biopharmaceutical manufacturing processes.

The new AI co-scientist is a multi-agent AI system that acts as a virtual scientific collaborator to aid scientific research.

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Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss the implications of FDA’s new draft guidance on complying with 21 CFR 211.110.

Feb. 11, 2025 marks the 10th anniversary of the International Day of Women and Girls in Science.

The optimization of processes for the development and manufacture of biopharmaceuticals is pivotal for producing quality products.

Dirk Margosch, Vice President Visual Inspection, Assembly & Secondary Packaging at Vetter Pharma-Fertigung GmbH & Co KG, provides advice on how to respond to defective vials in a batch and how to prevent future problems in secondary packaging.

FDA provides recommendations for those interested in participating in the agency's Advanced Manufacturing Technologies Designation Program.

The BioPharm International® editors present our most popular technical articles from 2024.

BioPharm International® spoke with Paul Mugford, director, Biologics Process Development at BIOVECTRA, to find out what approaches works best for optimizing processes in microbial fermentation.

The BioPharm International editors present our most popular video interviews from 2024.

Emerging therapies, patient-centric medicines, and the ever-changing world of bio/pharmaceuticals complicate technology transfer.

BioPharm International® spoke with Sujay Jadhav, CEO of Verana Health about trends in real-world data and the impact these trends will continue to have on the pharmaceutical industry in 2025.

Pointing to the continued circulation and evolution of COVID-19, WHO published a statement on the COVID-19 vaccine antigen composition to respond to variants of the virus.

EMA and HMA have published revised guidelines on identification of commercially confidential information and personal data used in marketing authorization applications.

Bob Schrock, PhD, senior director, global head of Process Development, at Lonza provides insight on how process controls change during development through commercialization, how cell harvesting can be optimized, and which validation and/or qualification studies are performed for cell culture.

Bob Schrock, PhD, senior director, global head of Process Development, at Lonza provides insight on how cell culture processes may be optimized and what kind of process studies are performed for cell culture.

Daniel Giroux, VP of Biologics Development at Abzena, discusses approaches for optimizing process development for the production of proteins.

EMA's committee gave recommendations for marketing authorization of 17 drugs in December, which include therapies for rare heart conditions, anemia, and liver disease.

AbbVie has completed its $1.4 billion acquisition of Aliada Therapeutics, giving it access to Aliada’s disease-modifying therapy for Alzheimer’s disease.

Cellipont Bioservices and Xiogenix Partner on Advanced Filling Systems The companies will offer Cellipont’s clients access to Xiogenix’ fill/finish system for cell therapy production.

With so many personnel involved in the development and manufacture of pharmaceuticals, proper training of all staff is key to ensuring a quality product.

A new platform allowing market authorization holders to report drug shortages has gone live.

In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, vice president, Technical at Parexel, discuss the new chapter, Chapter <86> Bacterial Endotoxins Test Using Recombinant Reagents

Jason Bock, co-founder and CEO of CTMC, discusses the industry impact and manufacture of patient-centered medicines.

The agency will review the company’s supplemental new drug application for vutrisiran, a treatment for ATTR amyloidosis with cardiomyopathy.

Operating in an aging facility and/or utilizing outdated equipment may lead to drug shortages and high operating costs.

With the launch of the Institute for Cell Therapy Discovery and Innovation, the MD Anderson Cancer Center will bring together expertise in developing cell therapies for cancer, autoimmune diseases, and infections.