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The purpose of the CMC Strategy Forum Europe 2020 is to offer a blend of topics that characterize the challenges facing the biotechnology industry in the next decade…
The new ICH Q14 guideline is proposed to harmonise the scientific approaches to analytical procedure development and provide the principles relating to the dossier description…
Continuous Manufacturing is the future standard for solid oral dosage forms. The greater process understanding, and control is redefining how drugs are produced. The faster, more precise and reliable manufacturing approach is enabling accelerated development…
The ICH Q12 Guideline on Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management and its Annexes reached Step 4 of the ICH Process at the ICH meeting in Singapore on 21 November 2019…
KBI Biopharma is a leading contract development and manufacturing organization for the biopharmaceutical industry. We accelerate and optimize drug development and manufacturing programs for our client partners…