Whitepaper: EU GMP Annex – sterile manufacturing
This whitepaper considers the latest EU GMP Annex 1 draft and its impact on the control and release of sterile products.
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This whitepaper considers the latest EU GMP Annex 1 draft and its impact on the control and release of sterile products.
Disinfectants must be qualified on the surfaces in a pharmacopeial manufacturing environment prior to use in the facility. Building a study with robust parameters and avoiding common pitfalls is critical to avoid negative responses from regulatory agencies.
The EMA’s drug safety committee concluded that the vaccine is not associated with an increased risk of thromboembolic events and that its benefits still outweigh its risks.
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.
iCON has improved delivery capacity by standardising the infrastructure for a flexible and readily available drug manufacturing facility.
iCON has improved delivery capacity by standardising the infrastructure for a flexible and readily available drug manufacturing facility.
This on-demand webinar will provide aspects of a sterility assurance program for a pharmaceutical product. Sterility assurance begins at the early stages of product development and follows through the entire product lifecycle.
The IDMP data standards aim to standardise the submission of data on medicinal products. Remco Munnik, Associate Director at Iperion, has been working with the EU focus group creating the EU IDMP Implementation Guide version 2, published late February. He explains why pharma companies need to act now in response…
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.