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API

Hospital-owned generics initiative unlikely to benefit the CMO industry, says GlobalData

A recently-announced plan to establish a not-for-profit generic pharmaceutical company is unlikely to be a boon to the contract manufacturing organization (CMO) industry, according to …

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automation

Boehringer Ingelheim signs global license agreement with inmation Software

Boehringer Ingelheim, one of the world‘s leading research-driven pharmaceutical companies, has signed a global license agreement to use the “enterprise:inmation” industrial information management system from …

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ADC

Poor aggregation will see ADC targets fail or face long delays

ADC Biotechnology (ADC Bio)‘s leading experts warn that best in class ADCs are being overlooked due to critical aggregation control problems. CDMOs are unable to …

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Due Diligence for Leachables and Extractables in a Modern GMP Environment
extractables

Due Diligence for Leachables and Extractables in a Modern GMP Environment

Regulatory guidance for extractables and leachables exists, but only provides general recommendations for ensuring patient safety. Diane Paskiet, Laura Stubbs and Heike Kofler at West Pharmaceutical Services provide an overview of extractable and leachable science.

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