Case study: Challenges in manufacturing high value lyophilised oncology drugs
Key features of a custom-made freeze-drying integrated solution.
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Whitepapers & App Notes
Application note: High-throughput fluorescence-based mAbs aggregation analysis workflow
Modern biologics development relies on the screening of 100s - 1000s of monoclonal antibody (mAb) variants to identify lead development candidates with optimal properties such as affinity, specificity, immunogenicity, and glycosylation.
Factsheet: Total Organic Carbon (TOC) back to basics
Total Organic Carbon (TOC) analysis is used to comply with compendia water testing requirements. Read this document to learn the basics on TOC.
Whitepaper: Going green in the cleanroom
Contec ReFIBE: a recycled polyester cleanroom wipe providing a sustainability story in a single-use world.
Application note: Combined Raman-SEM imaging for pharmaceutical studies
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.
Application note: Online cleaning validation for real-time equipment release using total organic carbon, inorganic carbon and conductivity data
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.
Application note: Synthesis confirmation for nucleic acid medicines – rapid sequence confirmation using a MALDI-TOF mass spectrometer
Medicines that utilise nucleic acids, such as DNA and RNA which control genetic information, are called "nucleic acid medicines".
Whitepaper: Beta-glucans in purified water – do they really cause overestimation of endotoxin values?
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.
Application note: Why extractables and leachables matter
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.
Whitepaper: Recombinant factor C: new Ph. Eur. Chapter 2.6.32
Pharmaceutical and medical device manufacturers can now use the compendial chapter 2.6.32.
Whitepaper: Combining rapid and EP bioburden testing
A combined testing procedure to overcome the manufacturing bottleneck caused by the time needed for compendial bioburden testing according to EP.
Whitepaper: SARS-CoV-2 vaccines and biosafety
Upholding biosafety standards in coronavirus vaccine development and manufacturing despite the acute worldwide need.
Whitepaper: Analyte binding to syringe filters
Validation of syringe filters for QC testing: The parameters that influence analyte binding to filters.
Fact sheet: 5 Secrets to a successful cleaning validation program
Here are five ways to ensure a successful and compliant cleaning validation program.
Whitepaper: Tips to improve SEC for mAbs and ADCs
Practical Tips for Monomer/Aggregate and Fragment Content Monitoring of monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs).
