Newsletter | October 18, 2019

10.18.19 -- Accelerating Biologic Manufacturing: Commercial Manufacturing and Scale-Up

 
Lyophilization of Highly Potent Drugs: Key Facility and Equipment Design Elements
 

Lyophilization ensures drug stability, delivers an extended shelf life, and enables long-term storage at room temperature. Because scale-up and technology transfer of the lyophilization process is challenging it is important to develop a comprehensive understanding of critical lyophilization characteristics early on.

5 Steps to Accelerated Biologics Manufacturing and Robust Scale-Up
 

Establishing a platform approach to process characterization ensures the entire process is robust, right the first time, and results in a highly consistent product to facilitate efficient BLA filing. This five-step process provides a thorough understanding of the biologic and process control strategies that accelerate time to a robust and reliable commercial scale process.

CMC Strategies for the Acceleration of ADC Commercial Manufacturing
 

The potential for antibody-drug conjugate (ADC) programs to accelerate from early-stage to late-stage clinical development highlights the need to establish commercial launch-ready manufacturing early and efficiently. Reduced time-to-market is key to deliver urgently needed therapeutics to patients, as well as to secure commercial success and maximize return on investment.

Finding Bioavailability Using Hot Melt Extrusion
 

Due to its immense adaptability, extrusion has been widely utilized in diverse fields. Recently it is being adopted by the pharmaceutical industry at an unprecedented pace to address various drug product formulation and manufacturing needs. Learn more about this exciting yet complex technology and the many advantages it offers.

Patient-Centricity: A Drug Development Imperative
 

Success in biopharmaceutical development is ultimately about facilitating positive patient outcomes. How is patient-centricity influencing the development process today, and what role do CMOs play? 

Optimize your Quality Agreement: Key Aspects to Know
 

Customers choosing to partner with a trusted CDMO for drug development and manufacture can benefit from an established quality policy addressing management responsibilities, risk management, documentation, change management, CAPA, and process performance and product quality. Leveraging the expertise of a CDMO to assure product safety is a proven approach to product realization.