Where now with quality by design?
Dave Elder discusses whether the goals of QbD have truly been met and questions whether the complex processes, lack of clarity and high costs have resulted in the promised global harmonisation.
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Dave Elder discusses whether the goals of QbD have truly been met and questions whether the complex processes, lack of clarity and high costs have resulted in the promised global harmonisation.
Within this in-depth focus are articles explaining the numerous benefits of in vitro human cell-based kidney models to study nephrotoxicity and drug-to-drug interactions as well as discussing the measures taken by API manufacturers to successfully navigate the pandemic and the opportunities this presents.
This issue focuses on whether our vaccine innovation capabilities will prepare us for future outbreaks, how Raman spectroscopy can be used to rapidly detect SARS-CoV-2 and the development of high-throughput glycoanalytics for biopharmaceuticals. Also included are articles on opportunities in the global API market and how to successfully identify defects…
A combined testing procedure to overcome the manufacturing bottleneck caused by the time needed for compendial bioburden testing according to EP.
Upholding biosafety standards in coronavirus vaccine development and manufacturing despite the acute worldwide need.
When adjuvanted with GSK’s pandemic adjuvant system, the S-Trimer vaccine candidates induced the production of neutralising antibodies in all trial participants.
Practical Tips for Monomer/Aggregate and Fragment Content Monitoring of monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs).
Single-use systems come with their own extractables and leachables challenges. Although there are no formal guidelines yet, safety must be assessed.
Secure your Pharma analysis & QC - Take your journey through our small molecules and biologics analysis & QC regulatory compliant portfolio.
A new nasal spray with ingredients already approved for use in humans could be used to protect people against COVID-19.
At Lonza, we have developed our CFS 1200® capsule filling and sealing machine as part of our Lonza Engine™ portfolio. Used with our Capsugel® capsules, pharmacies can automate this process to optimise operations and accuracy. This fact sheet will introduce you to its handling and sealing capabilities, key benefits, performance…
Risk mitigation interactive tool to guide you through the challenges and quality requirements of your bio-manufacturing process.
11 November 2020 | By Thermo Fisher Scientific
In this on-demand webinar we explore the evolving role of handheld and portable instruments to drive quality improvements and manufacturing success in 2021.
Aubrey Dan explains how EmpowerPharm developed its synthetic CBD tablet and why a novel formulation could help combat a range of indications.
When a client gets an opportunity to expand rapidly, it takes a global partner to pull it off without a hitch.