Update your blue dye ingress test and generate robust analytical CCI data in all stages of the product life cycle.
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13 January 2021 | By Altasciences
Join us on 9 March 2021 at 14:00 GMT for an overview of a foreign health authority’s requirements for gaining approval to conduct an FIH clinical trial by comparing Health Canada and European Medicines Agency (EMA) Clinical Trial Authorisation (CTA) processes to that of the FDA IND submission.
A summary of the current state of container closure integrity testing in the pharmaceutical industry.
This on-demand webinar focuses on the importance of cleaning & disinfection, covering legal requirements & the global guidelines for disinfection in cleanrooms.
Total Organic Carbon (TOC) analysis is used to comply with compendia water testing requirements. Read this document to learn the basics on TOC.
Here are five ways to ensure a successful and compliant cleaning validation program.
Charles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts.
Numerous developments are ongoing to make advanced therapy medicinal products (ATMPs) more accessible, effective and less expensive. Here, legal experts Robert Stephen and Jane Hollywood from CMS discuss the increasing prevalence of these highly regulated therapies and the challenges faced by innovators in this space.
Treatment with Zolgensma® (onasemnogene abeparvovec) resulted in rapid and sustained improvement in motor function in spinal muscular atrophy (SMA) patients.
A report has said that with only 152 CMOs able to manufacture the 7,000 cell and gene therapies in the pipeline, production bottlenecks may occur.
The rapid evolution of the COVID-19 situation has created significant barriers to normal operations, from locking down borders to the imposition of restrictions on trade and export – not to mention a surge in demand for many common medicines. Each of these events in isolation can affect production and supply,…
RNAdvance Viral Kits. High-quality RNA extraction from saliva or swab transport media. Automation ready. LoD demonstrated at 1 copy/μL.
Reduce input sample to femtomolar levels. Miniaturise gene assembly reactions up to 100-fold. Streamline NGS verification of assembly.