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| home > white papers > Optimize your Biologic’s Analytical Program for Greater Risk Reduction - Merck |
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 WHITE PAPERS |
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Merck
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Optimize your Biologic’s Analytical Program for Greater Risk Reduction
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Analytical methods are used throughout upstream and downstream processes to help ensure the desired molecule is being produced with the desired purity. In addition to having the right molecule, quality must be confirmed in terms of glycosylation, oxidation, aggregates, activity and concentration. The analytical package must also ensure that all impurities from the manufacturing process and environment are consistently removed.
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News and Press Releases |
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3P innovation Announces Transition to Employee Ownership
Award-winning, UK based engineering and process automation company, 3P
innovation Ltd, is proud to announce that it is now an employee-owned
company. This transition has been taken to secure its long-term future,
for the benefit of customers and employees alike.
More info >> |
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White Papers |
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EU GDP Guidelines: Implications for Shipping Clinical Materials into the European Market
PCI Pharma Services
Recently, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) opened an investigation into a patient complaint of mold on paracetamol (acetaminophen) tablets (1). It discovered the product was shipped by sea from India to multiple companies in the UK at temperatures reaching up to 60 degrees Celsius. Labeling for paracetamol tablets typically states they should be kept below 30 degrees Celsius. In addition, MHRA discovered the humidity levels exceeded 80 percent during shipping, which is too high for the packaging that was used.
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Industry Events |
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DIA Europe 2021
15-19 March 2021, VIRTUAL CONFERENCE
DIA Europe is the must-attend event for all life science professionals
working in drug development, from discovery to marketed use. It
encourages open collaboration by bringing together representatives from
the entire spectrum of the life science landscape and facilitating
crucial discussions across several topic tracks: Clinical Development,
Regulatory Strategy, Pharmacovigilance, Value and Access, Health Policy,
and many more.
More info >> |
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