BioPharm International Editors

Articles

PDA/FDA Joint Regulatory Conference 2024: Sept. 9–11, 2024

The co-sponsored event includes sessions, interactive discussions, regulatory updates, and case studies regarding the current good manufacturing practice requirements.

PDA BioManufacturing Conference 2024: Sept. 24 and 25, 2024

The event will explore new technologies such as AI, digital twins, development approaches, CMC strategies, and regulatory frameworks, supporting rapid access to vaccines and biotherapeutics.

PDA Pharmaceutical Microbiology Conference 2024: Oct 7–9, 2024

This event will feature a look at the crucial nexus between scientific advancement and regulatory adherence.

CPHI Milan 2024: October 8–10, 2024

CPHI Milan connects thought leaders and innovators in the pharma industry.

AAPS 2024 PHARMSCI 360: October 20-23, 2024

The event covers Discovery and Basic Research, Preclinical, Clinical and Translational Sciences, Bioanalytics, Manufacturing and Analytical Characterization, Formulation and Delivery, and Career Development.

Crucial Points from a Manufacturing Perspective (PDA/FDA Joint Regulatory Conference 2023)

Sander Van Gessel, MEng, Business Unit Director, DFE Pharma, discusses the important components of nitrosamine impurities from a manufacturing point of view as a part of his session, "Reducing Nitrosamines Without the Use of Scavengers: The Critical Role of Excipients - An Excipient Manufacturer's View."

The Recent Discoveries of Nitrosamine Impurities (PDA/FDA Joint Regulatory Conference 2023)

Sander Van Gessel, MEng, Business Unit Director, DFE Pharma, discusses the recent findings of nitrosamine impurities in human drugs as a part of his session, "Reducing Nitrosamines Without the Use of Scavengers: The Critical Role of Excipients - An Excipient Manufacturer's View."

Highlighting CAR-T as an Important Modality (PDA/FDA Joint Regulatory Conference 2023)

Bassem Gayed, PhD, Senior Technical Director of CAR-T Process Engineering, Manufacturing Science & Technology at Bristol Myers Squibb, discusses the importance of CAR-T as a modality and other highlights from his part of the session, "Process Validation for CAR-T Products: A Continuous Journey."