BioPharm International Editors

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

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.

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

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

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

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."

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."

Humberto Vega, PhD, Executive Director, Bristol Myers Squibb, discusses the requirements needed to be successful in global cell therapy as a part of his session, "Successfully Navigating Global Cell Therapy Requirements."

Humberto Vega, PhD, Executive Director, Bristol Myers Squibb, discusses the journey from clinical to commercial cell therapies as a part of his session, "Successfully Navigating Global Cell Therapy Requirements."

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."

Catalent provides fill/finish services across a range of product formats from clinical to commercial scale.

Bassem Gayed, PhD, Senior Technical Director of CAR-T Process Engineering, Manufacturing Science & Technology at Bristol Myers Squibb, discusses the connection of process validation and CAR-T processes.

Maik Jornitz, Principal Consultant, BioProcess Resources LLC, discusses how to upgrade facilities in an efficient manner and other highlights from his presentation.

Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses the importance of continuous manufacturing for the future.

Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses the highlights of her ICH Q13 session that she wants others to be aware of.

Maik Jornitz, Principal Consultant, BioProcess Resources LLC, discusses the definition of patient safety and how to implement new technologies into upgraded facilities.

Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses how advanced manufacturing technology can improve things such as cost and efficiency.

Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses the barriers to the development of continuous manufacturing processes after implementing ICH Q13.

Part of the session "Transforming Medicine: Unleashing the Potential of Cell and Gene Therapies," Sadelain discusses CAR-T cells for immunotherapy and the future of cell/gene therapies.

The new guidance provides detailed recommendations to drug developers with a target of helping to ensure that drug developers provide adequate information to assess potency at each stage of a product’s life cycle.

Lilly will cap insulin prices for patients with and without insurance at $35 per month.

AstraZeneca has entered into a global exclusive license agreement with KYM Biosciences for CMG901, which is being investigated as a gastric cancer treatment.

Moderna and Merck’s investigational personalized mRNA cancer vaccine has been granted Breakthrough Therapy Designation by FDA.

WHO is appealing for US $392 million to reach 12.9 million people with essential health assistance in 2023.

Orchard Therapeutics has announced an agreement which will enable reimbursed access to Libmeldy for all eligible MLD patients in Sweden.

Bio-Rad’s newly launched StarBright Blue and StarBright Yellow dyes are intended for use in various flow cytometry applications.

Eurofins Viracor ExPeCT CAR-T qPCR assay is a tool designed for monitoring and optimizating CAR-T therapies.

Moderna will leverage Life Edit’s suite of gene editing technologies to advance development of in vivo gene editing therapies.

Sanofi’s once-weekly replacement therapy is FDA-approved for prevention and treatment of bleeding episodes in people with hemophilia A.

AbbVie and Capsida have expanded their existing collaboration to advance three new gene therapy programs.