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This application note presents correlative Raman Imaging and Scanning Electron (RISE) microscopy as a useful tool for investigating the fine structure and chemical composition of pharmaceutical samples.
Cleaning validation is an important element to current good manufacturing practice (cGMP) manufacturing to ensure purity, quality and potency of drug product. Above all, patient safety is the primary concern.
Medicines that utilise nucleic acids, such as DNA and RNA which control genetic information, are called "nucleic acid medicines".
Over the last century, the bacterial endotoxin test (BET) has evolved to keep pace with modern technology and lab expectations: from rabbit pyrogen testing to Limulus amebocyte lysate (LAL), to current developments with recombinant horseshoe crab coagulation factors.
Nelson Laboratories, with their unique database of over 6,000 compounds for detection, discuss the testing requirements for extractables and leachables and why identification and quantification in extraction studies will become increasingly crucial for pharmaceutical and medical device product safety and integrity.
Pharmaceutical and medical device manufacturers can now use the compendial chapter 2.6.32.
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.
Validation of syringe filters for QC testing: The parameters that influence analyte binding to filters.
Here are five ways to ensure a successful and compliant cleaning validation program.
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.
In this Q&A, you will find responses from our experts to the 20 toughest questions the community raised about Pharma analysis & QC challenges.
Secure your Pharma analysis & QC - Take your journey through our small molecules and biologics analysis & QC regulatory compliant portfolio.
Challenges in day to day operations. The battle of performance in production.
