News

New regulations, including those put forth by Annex 1, require many pharmaceutical manufacturers to rethink their facility designs to promote compliance.

Jay Rajagopalan, senior director—Engineering & Product Management for Malema at PSG Biotech, shared insights at on how current industry trends are shaping the development and advancement of sensor technologies.

Pharmaceutical Technology® spoke with Nicole Hunter, Watson-Marlow Fluid Technology Solutions’ head of Global WMArchitect, about the impact single-use technologies have on fluid-handling workflows in bioprocessing.

The improvement of ADC manufacturing now demands increased containment requirements and continually advancing analytical detection of molecules in manufacturing spaces.

CordenPharma’s partnership with GENEPEP expedites lead development and validation in project phases, and its LNP β-sitosterol supports sustainable emission reduction targets.

Wenyu Zhang, PhD, addressed new trends in the aseptic industry and the chief concerns companies should keep in mind while weighing their options, at INTERPHEX 2024.

Susan Schniepp, distinguished fellow, Regulatory Compliance Associates, and co-chair of board of directors, Parenteral Drug Association, demonstrates QMS impact on quality maturity at INTERPHEX.

At INTERPHEX 2024, Pharmaceutical Technology sat down with Christa Myers of CRB Group and Nadiyra Walker Speight of Fujifilm Diosynth Biotechnologies to discuss implementation of Annex 1.

The Xcellerex magnetic mixer, single-use mixing system was designed to address challenges in large-scale mAb, vaccine, and genomic medicine manufacturing processes.

Former FDA drug investigator, Daniel Roberts, discusses the importance of updating process validation and maintaining proper data integrity at a keynote session during INTERPHEX.

The airlock solution for cleanrooms offers contamination controls for a highly controlled environment.

At INTERPHEX, Bill Whitford, Strategic Solutions leader at Arcadis, discusses the progress made in 3D bioprinting toward commercial biologics production.

WMFTS has launched WMArchitect, a single-use product line that offers ready-to-use single-use assemblies and custom-designed workflows for biopharma fluid management.

The LNP success in mRNA vaccines leads to their establishment as a standard in mRNA delivery.

C3TI will promote CDER’s clinical trial innovation activities both internally and externally.

The agency’s risk assessment committee has concluded that available evidence has not been found that supports a causal association between glucagon-like peptide-1 receptor agonists and self-harming thoughts and actions.

The draft guidance provides recommendations for data integrity for clinical and bioanalytical portions of bioavailability and bioequivalence studies submitted with drug applications.

Charles River has entered into separate agreements with Axovia Therapeutics and Ship of Theseus to offer plasmid DNA manufacturing services for a gene therapy and a lead candidate program, respectively.

With the launch of a new manufacturing service, Memel Biotech will offer services for discovery through to formulation for advance therapy medicinal products.

In this latest installment of the Europa Perspectives series, Alexander Natz, Secretary General at EUCOPE, delves into the European Commission’s new measures aimed at making lifecycle management more efficient across the European Union.

Zevtera has been approved to treat three types of bacterial infections and has been granted Priority Review and Fast Track and Qualified Infectious Disease Product designations.

Under a collaboration agreement, Lonza will manufacture sabirnetug, Acumen Pharmaceuticals' mAb in clinical development for treating Alzheimer’s disease.

Genmab's acquisition of ProfoundBio will boost its clinical and preclinical pipeline of ADCs for targeted cancer treatment.

The annual report details OPQ’s quality assurance work for 2023 including its support for the creation of guidance documents.

Our Future Health, a health research program in the UK, has welcomed Novartis as a new industry partner.

Plans to update the European Union’s variation framework have been finalized.

Carl Allenspach, director of business operations, manufacturing, science, and technology organization at Bristol Myers Squibb discusses the interactive and collaborative important of INTERPHEX.

The European pharma industry needs to be prepared for the new clinical data requirements.

A revised regulatory variation framework should make lifecycle management more efficient in Europe.

Experts believe it is likely cancer cells are more common in the body than previously thought, but typically caught early and removed in the body’s cancer-immune cycle. When the system is in good working order (and protecting us), dead cancer cells release neoantigens.