Balancing Change and Certainty in Manufacturing
As new manufacturing processes and technologies are introduced to meet demand and overcome challenges, understanding also needs to improve to ensure the right balance is achieved.
Formulating Drugs for Continuous Processing
Despite the advantages intensified processes can offer developers, there are still some obstacles to overcome before broader application of new technologies will be implemented.
Quality Challenges Associated with Cryo/Lyoprotectants
Impurities and batch-to-batch variability present the biggest challenges.
Small Footprint Automated Closed Production Platforms for CAR-T and Other Advanced Therapies
Limitations in production platforms have impeded continuous manufacturing for advanced therapies.
Packaging Becomes More Sustainable
Manufacturers and suppliers join forces to reduce the pharmaceutical industry’s carbon footprint.
Accepting Alternative Approaches to Freeze Drying
Alternative approaches to freeze-drying are gaining popularity and will help to overcome some of the challenges associated with conventional lyophilization.
Considerations for Analytical Testing for E&L
Considering the differences between small- and large-molecule drug products can help determine analytical testing methods for E&L.
Contract Testing Services Solidify Their Place in the Manufacturing Value Chain
Contract testing services demonstrate a major increase in the speed and efficiency of testing using new testing methods and technologies.
A New Hope for Children Living with HIV
New child-friendly treatment options and initiatives are improving the outlook of children living with HIV in Europe.
Kudos and Hurdles in Tackling Rare Diseases
FDA has spurred investment to create and develop 600 therapies.
Changes Afoot in Pharmaceutical Laws and Regulations in Spain
Proposed regulatory changes signal a major overhaul of legislation governing pharmaceuticals and healthcare in Spain.
The Relationship Between CAPAs and Data: What’s the Right Balance?
A risk assessment should be performed as part of the CAPA process, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.
Zauberkugel: Pfizer’s Seagen Acquisition
What can we take away from Pfifzer's acquisition of Seagen?
Legislative Hold-Up
A further setback to the publication of the pharmaceutical legislative changes in Europe may mean time is running out for appropriate review before 2024 parliamentary elections.
Who’s Got Game?
Direct-to-consumer drug advertising has developed as a cottage industry which has been used to increase prescriptions immensely.
Multi-Agitator Low-to-Medium Viscosity Mixer
The ROSS Model CDA-200 is fitted with multiple agitators for semi-continuous operation.
High-Performance Spectrometer
The Thermo Fisher Scientific Nicolet Summit X FTIR Spectrometer is a high-performance system designed for flexibility, ease of use, and high productivity.
Cytometry Application Dyes
Bio-Rad Laboratories StarBright Blue and StarBright Yellow dyes are conjugated to flow validated antibodies, supporting flow cytometry panel design in immunology design.
Automated mRNA Synthesis Kit