Newsletter | September 14, 2021

09.14.21 -- Best Practices For Raw Material Supplier Change Notifications

Featured Editorial
Industry Insights
Five Dangers Of An Insecure API Supply Chain

The diversity and agility of API supply chains are key to ensuring that medicines can be manufactured and delivered to patients on time, even in the face of challenges and unforeseen circumstances.

Data-Driven Approach Optimizes Robust, Scalable Lyophilization Process

Selecting the right manufacturing partner with appropriate lyophilization expertise, experience, and analytical capabilities can speed drug development and expedite time-to-market for lyophilized drugs.

Does Your CDMO Have Sustainable API And RSM Strategies?

How can you be sure the CDMO you select has appropriate oversight and management of their risk and safety management (RSM) and API manufacturing supply chain, to prevent you from experiencing costly delays that disrupt your timeline?

Co2 Incubator: Guide To Proper Use And Preventive Maintenance

This guide will help lab managers understand risks and best practices as they develop training for CO2 incubator users and establish a preventive maintenance program and setup criteria.

How Should You Prepare For Foreign FDA Inspections During COVID-19?

As the COVID-19 pandemic continues, it is important to understand the expectations of regulators about how to facilitate paper-based facility inspections in lieu of those performed on site.

Navigate The Chemistry, Manufacturing, And Controls (CMC) Regulatory Landscape For Cell And Gene Therapies

The curing potential of cell and gene therapies is driving the industry to gain a better understanding of the evolving regulatory guidelines for these products, in order to bring them to market faster.

How To Build A Robust Packaging Strategy For Rapid Commercialization

Look at the elements involved in building a robust packaging strategy and the key technical considerations in packaging design and operational planning for products of various sizes.

In Vitro Tests To Characterize Bioavailability Enhancing Formulations

Formulators have many choices in their tool kit when it comes to bioavailability enhancement, so the tough call becomes which one to use for a given compound.

Liquid-Liquid Mixing Characterization And Slurry Suspension

Correct mixing parameters and controls are key elements for successful mixing operations, particularly in the transition from non-single-use platforms to single-use platforms. 

Transforming Your Biopharma Automation Capabilities

The seamless functionality of single-use technology equipped with a scalable distributed control system (DCS) empowers you to capture the benefits of collecting and sharing data while simultaneously creating a connected enterprise that grows with the pace of your business.

Technical Considerations For Developing Oral Solids (Part 2)

In the second installment of this series, experts from Pfizer CentreOne’s global network and partner organizations consider the effects of equipment design and different tablet strategies.

Paving The Way For Tomorrow’s Medicines

There is a great need for innovative technologies that can improve the success rate for new drug candidates and pave the way for novel therapies to reach the market. Recent advances in nanoparticle engineering technology promise to accomplish precisely this.

Large-Scale Adeno-Associated Virus (AAV) For Preclinical Gene Therapy Studies

UMMS and Cytiva have collaborated to manufacture GLP-grade viral vector, giving you access to industry-leading development platforms and processing equipment plus professional and scientifically knowledgeable staff to help you get your research to the clinic faster.

Headspace Moisture Analysis For Determination Of Residual Moisture Content In Lyophilized Pharmaceutical Products

This article describes how rapid nondestructive headspace moisture determination enables the generation of insightful data for product life cycle activities.

Quality By Design Principles For Analytical Methods

In this case study, a quality by design (QbD) approach was used to solve a high-performance liquid chromatography (HPLC) analytical method problem where impurity peaks had shifting retention times, making identification and quantitation problematic.

Commercial Manufacturing In Half The Time

Due to U.S. FDA requirements for commercial manufacturing of regulated GMP intermediates, a global pharma company quickly needed a dedicated production facility to produce its commercial antibiotic (carbapenem) intermediate.

A Complete Guide To Aseptic Manufacturing

Aseptic manufacturing is a uniquely challenging process that requires expertise and careful planning for successful execution. Gain valuable insights and guidance on aseptic manufacturing, sterile fill/finish, and its supporting activities

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