臨床薬理学および生物薬剤学

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Biopharmaceutical Manufacturing: An Evolving Industry

James A Uchizono

The biopharmaceutical assiduity is evolving with a shift in focus from recombinant proteins and antibodies towards more complex cell and gene curatives. To be competitive encyclopaedically, bio manufacturers need to concentrate on aligning with global norms with regard to medicine quality, reducing manufacturing failures and delivering medicines to vend snappily. Erecting these capabilities requires a multifaceted approach that includes advancements in operations, quality compliance, and control strategies. To address these requirements, the US Pharmacopeia (USP), the Department of Biotechnology (DBT) India, and the Confederation of Indian Industry (CII) held a council to bandy the conditions and gaps in the biotechnology and pharmaceutical sectors in India and other developing countries.