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Strategies for Biotech Companies to Scale Up Commercially through Effective Project and Risk Management Varun Choudhary
BULLET : Jurnal Multidisiplin Ilmu Vol. 1 No. 05 (2022): BULLET : Jurnal Multidisiplin Ilmu
Publisher : CV. Multi Kreasi Media

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Abstract

Growing biotechnology operations provide potential and problems for businesses across a range of industries, including industry, healthcare, and agriculture. With a focus on efficient project and risk management, this thorough review examines approaches, factors, and implications for commercial scale-up in biotech enterprises. In order to effectively navigate the intricacies of biotech scale-up, align objectives, proactively identify and mitigate risks, optimize resource allocation, and stimulate stakeholder participation and communication, it is imperative that project and risk management methodologies be integrated. Case studies provide best practices and lessons learned from successful commercial scale-up initiatives in the manufacturing of cell therapies, agricultural biotechnology, and biopharmaceuticals. Advances in precision medicine, synthetic biology, digitalization, omics technologies, sophisticated therapeutics, bioprocessing breakthroughs, and international partnerships are some of the future trends and prospects in biotech scale-up. With an emphasis on resource efficiency, renewable energy, waste reduction, green chemistry, biodiversity protection, and life cycle assessment, sustainability and environmental issues are critical to the biotech industry's scale-up. The ethical and social ramifications of biotech scale-up include questions of genetic engineering and manipulation, data ownership and intellectual property, privacy and informed permission, access and equity, dual-use research and biosecurity, environmental sustainability, and social responsibility. Biotech businesses can optimize the advantages of scale-up initiatives while avoiding risks and guaranteeing good societal effect by taking these factors into account and adopting responsible stewardship practices.
COVID-19 as a Catalyst for Innovation: Pharmaceutical Industry Manufacturing Techniques and Management of Endemic Diseases Anirudh Mehta; Varun Choudhary
International Journal of Multidisciplinary Sciences and Arts Vol. 2 No. 4 (2023): International Journal of Multidisciplinary Sciences and Arts, Article October 2
Publisher : Information Technology and Science (ITScience)

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.47709/ijmdsa.v2i2.2996

Abstract

The lockdown measures of the Covid-19 pandemic have significantly impacted change in pharmaceutical manufacturing technology, regulation and global supply chains. To respond to unprecedented global demand, significant advances took place and these include platform-based manufacturing such as mRNA and viral vector vaccines, shift to continuous manufacture. Indeed, reducing harm to the buying public through the preservation of product safety and quality, the regulatory modifications such as the EUAs and concurrent process validation accelerated the approvals of vaccines. To achieve the effective knowledge transfer for collaboration like COVAX, the fair distribution of vaccinations for every country in the world was ensured. The fact is that all these concerns will be crucial for maintaining the preparedness for other future health threats in case the pandemic turns into the endemic phase. If the pharmaceutical sector is to make greater investments in scalable production technology, regional manufacturing events and unified regulations they will be in a position to respond to new public health threats in a more efficient manner. In this abstract, the author discusses the lessons learned and their relevance in future global threats and emphasizes the transformative nature of COVID-19 in the generation of pharmacy manufacture.