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What is process characterization?

Process characterization is an essential step in the commercialization of a new (biological) drug. For drug product commercialization, manufacturers must validate the drug’s manufacturing process. This ensures that the manufacturing process delivers consistently a quality product and that the patient is not at risk.
What is process characterization?
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News and Press Releases

Optimizing pharmaceutical processes

An increase in requirements from regulatory agencies around the world, combined with a growing demand for drugs in prefilled injections systems – a trend that industry experts have projected will continue – has led pharmaceutical and biotech supply chains to gain in significance. Well established and optimized processes are crucial for offering uninterrupted market supply. To satisfy its customers a CDMO must foster flexibility, efficiency and safety throughout the entire supply chain. The most important goal for all parties involved in the bio-pharma business is maximization of product quality where even small decisions can make a big difference. Future-oriented pharma processes can add value to any compound.
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White Papers

Backward Thinking

Development of a generic equivalent to a current marketed pressurized metered dose inhaler (pMDI) product brings immense challenges. Thorough analysis is critical to gain a comprehensive understanding of the physical attributes and pharmaceutical performance of the reference marketed product. Many factors need to be assessed, understood and combined in order to successfully develop a generic pMDI which will meet the regulatory and quality requirements as an equivalent product in the anticipated target market.
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Industry Events

Clinical Operations in Oncology Trials West Coast

17-18 November 2020, Hilton San Francisco Airport Bayfront

Clinical Operations in Oncology Trials West Coast will be returning this April for another 2 day event full of thought-provoking presentations, discussions and roundtables. This years' conference highlights include the high-level, interactive immuno-oncology discussion panel where specialists from Shasta Bio Ventures, Abbvie and BeiGene shared their top tips on how to run successful and impactful immuno-oncology studies.
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