Journal of Pharmaceutical Innovation
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602
(FIVE YEARS 232)

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30
(FIVE YEARS 3)

Published By Springer-Verlag

1939-8042, 1872-5120

Author(s):  
Shao Hua Lu ◽  
Ming Cai Zhang ◽  
Hong Lin Zhai ◽  
Ke Xin Bi ◽  
Bing Qiang Zhao

Author(s):  
Midhu George Veeran ◽  
Resmy Rachel Thomas ◽  
Reshmi Ramakrishnan ◽  
Bharaniraja B ◽  
Abi Santhosh Aprem

Author(s):  
Arindam Halder ◽  
Malay D. Shah ◽  
Bharat Pateliya ◽  
Vinod Burade ◽  
Ajay J. Khopade

Author(s):  
Annu Uppal ◽  
Ranjan Chakrabarti ◽  
Narendra Chirmule ◽  
Anurag Rathore ◽  
Fouad Atouf

AbstractThe biopharmaceutical industry is evolving with a shift in focus from recombinant proteins and antibodies towards more complex cell and gene therapies. To be competitive globally, biomanufacturers need to focus on aligning with global standards with regard to drug quality, reducing manufacturing failures and delivering drugs to market quickly. Building these capabilities requires a multifaceted approach that includes improvements in operations, quality compliance, and control strategies. To address these needs, the US Pharmacopeia (USP), the Department of Biotechnology (DBT) India, and the Confederation of Indian Industry (CII) held a symposium to discuss the requirements and gaps in the biotechnology and pharmaceutical sectors in India and other developing countries. A panel of experts from academia, manufacturing, and governmental agencies identified several drivers needed for capability building, including a skilled workforce, public–private partnerships, advanced manufacturing technologies, novel biologics, and favorable policies. This article summarizes the recommendations put forward by this panel.


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