04.29.24 -- Outsourcing Through An Industry-Government Battle

Dive into the biopharmaceutical realm, where the synthesis of biologically derived APIs encompasses cell line development, fermentation, and sophisticated purification techniques. Outsourced Pharma Capacity Update’s new PARTNER WEEK will include a session featuring CDMOs with capacity for meeting the production demands of your Large Molecule Drug Substance and Development projects. Join this digital event happening May 21st.

Analytical challenges morph phase-by-phase during drug development. Three Novartis scientists describe a platform approach based on guidance from the ICH and USP.

Learn how the visualization of critical cellular responses can enable live-cell imaging to indicate effective payload delivery, increasing the potential of identifying clinically viable ADC leads.

We give an overview of the theory of scaling, present workflows and strategies, discuss which data are needed for successful scaling, and present case studies that use a web-based scaling tool.

Pouring millions into the infrastructure and quality systems necessary to move away from manual filling is unrealistic and detracts from your strengths in drug development.

Process replication at a small scale, verification runs, and satellite runs conducted in parallel to manufacturing are valuable risk mitigation tools that maximize efficiency and product quality.

As you search for a supplier best suited to help manufacture your product, prioritize the CDMO with previous plasmid production experience needed to avoid common manufacturing obstacles.

It is crucial to start off your product development right. Here, you will learn how to best approach virus bank production. Review best practices, how to overcome common obstacles, and more.

Explore how the widespread adoption of auto-injectors is transforming the biopharmaceutical industry's approach to drug delivery, offering precise dosing, patient adherence, and safety.

Current delivery systems for the encapsulation of Nucleic Acids have both strengths and weaknesses. Join us on May 6th to understand the relevance of Critical Quality Attributes for Encapsulation Processes, gain an insight into what is possible with innovative LNP encapsulation methods and learn more about cGMP aspects of LNP encapsulation.

Our viral vector and cell therapy manufacturing platforms tap into the technology, regulatory, and scale-up expertise required for cell and gene therapy development.

ArQ - Vita can achieve large volume, deep intramuscular delivery, making it the ideal platform to deliver medication for chronic conditions.

Lonza’s Drug Product Services (DPS) offering delivers a holistic approach to DP development that anticipates and prevents problems early, and ensures the result is a product that is fit for purpose.

This brochure introduces the potential for problems at BLA submission where a recent analysis of FDA complete response letters showed that 47% of the products that received them had CMC analytical issues.