INSIGHTS ON CONTRACT PHARMA MANUFACTURING

• Developing An Effective Lyophilization Cycle

  Learn how and why a contract manufacturing and development organization (CDMO) that specializes in lyophilization relies on freeze drying systems.

• Five Trends Driving Lyophilization

  Learn more about the trends driving the need for lyophilization: biopharmaceuticals, scalability, a growing geriatric population, rising chronic diseases, and cold chain and storage.

• Top Reasons To Outsource Your Early Biologic Development And Manufacturing To A CDMO

  Small, mid-sized and large biotech companies discuss major hurdles they encountered and how a customer-centric CDMO partnership can help overcome these, dismissing the idea of one-size-fits-all.

• 5 Ways Modern MES Solutions Meet Pharma Manufacturing Needs

  As a pharmaceutical product manufacturer, you regularly deal with a lot of processes, phases, and moving parts along the supply chain to get your products to market. The pharmaceutical industry is complex and highly competitive. It has become essential to seek out ways to scale, improve processes, minimize errors, reduce lead times, and keep quality and compliance at the top of the priority list.

• Key Financial Considerations For Phase II Clinical Injectable Drug Manufacturing

  This article highlights the importance of scalability and flexibility in the choice of an early-stage manufacturing strategy and how that decision impacts financial outcomes for a drug development program.

• Nuances Of Quality Management Keep Biopharmaceutical Manufacturing Projects In Control

  Although many quality processes may seem one-size-fits-all, nuances surrounding how a CDMO onboards and operates will affect the speed, efficiency, and outcome of your projects.

• Quick Guide To Recent FDA Draft Guidelines

  Recent FDA draft guidance outlines the need to "help stakeholders develop, maintain, and implement risk management plans (RMPs) to proactively assist in the prevention of human drug product and biological product shortages."

• The Digitalization Of Biopharma Process Development, Manufacturing

  The fourth industrial revolution is coming. Explore the three essentials of bioprocess development and manufacturing digitalization: digital literacy, digital trust, and prioritization.

• Delivering A Large-Scale Product At A Rapid Pace

  A pharmaceutical client needed to introduce, manufacture, and validate five stages of challenging chemistry to support a Phase III clinical development program.

• 3 Biopharma Contract Manufacturing Trends You Must Know

  Review three biopharma contract manufacturing trends that are indicators of exciting industry developments and also reveal areas that are ripe for change.