The journey from large molecule to approved biotherapeutic is long, costly, complex, and fraught with risk – yet rewards for success are substantial.
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This paper takes a closer look at plastic storage bags for bioprocesses focusing on a shift from multilayer to single-layer storage solutions.
A framework to enable a holistic approach to CCI that assures both primary packaging and process contribute to good CCI of sterile vial product.
This whitepaper considers the latest EU GMP Annex 1 draft and its impact on the control and release of sterile products.
Replacing traditional moisture analysis methods with a rapid, analytical and non-destructive method to improve the quality of freeze-dried product.
A fast, high-resolution, and reproducible reverse phase HPLC method using the BIOshell™ A400 Protein C4 column to analyse the intact mAb Trastuzumab.
What is dissolution testing, why is it critical, what to consider for your method validation? Learn more in this quick guide.
Recent technological advances have made it easier to cope with the complexity of mass spectrometry (MS) based glycan analysis.
Key requirements to ensure patient safety in the present-day development and production of viral vaccines, and the challenges going forward.
Product characterisation facilitates easier process design to ensure the biological drug attains critical product safety, purity, and potency.
Readily deployable, fully integrated mobile testing labs for fast-track delivery of diagnostic and analytical lab capability where and when needed.
The use of flexible mobile biocontainment and test units to prevent the spread of transmissible diseases.
A stability study that provides an opportunity to extend the product shelf life, by optimising the formulation and/or product packaging.
Fact Sheet: Process analytical technology and real-time TOC testing of pharmaceutical grade water systems
Learn how Process Analytical Technology (PAT) and real-time TOC testing of pharmaceutical grade water systems can improve efficiency.
See how compliant products, unique packaging and smart labels make EMSURE® inorganics and solvents the smartest choice for pharmaceutical analysis.