BioE3 Policy for fostering High-Performance Biomanufacturing approved by Union Cabinet

Context: Union Cabinet led by Prime Minister has approved the ‘BioE3’ (Biotechnology for Economy, Environment & Employment) Policy for Fostering High Performance Biomanufacturing of Department of Biotechnology under Ministry of Science & Technology. 

Biomanufacturing

Biomanufacturing refers to the use of engineered microbial, plant and animal (including human) cells with increasing precision and control to produce commercially important products on scale.

Importance of Biomanufacturing in India

Biomanufacturing can transform from today’s consumptive manufacturing paradigm towards one based on regenerative principles and circularity. It will facilitate sustainable and efficient utilisation of biological resources.

It is particularly useful in sectors like specialty chemicals, enzymes, biopolymers, functional foods, smart proteins, veterinary products, precision biotherapeutics, services and carbon capture for addressing climate change.

• Industrial biotransformation of specialty chemicals industry: Considering the global push towards sustainable manufacturing in the light of climate change, there is a huge scope for biotransformation of chemical processes. There is a need to drive industrial biotransformation, ensure sustainable bio-based production of high-value specialty chemicals, enzymes and biopolymers through synthetic biology and genetic engineering. 
• Smart proteins and functional foods: Bio-manufacturing tools like synthetic biology and metabolic engineering can address the nutritional deficiency problems by promoting alternative/smart proteins which include proteins from new sources (like plants, algae, fungi, insets) and from new approaches (like fermentation, plant-based meat or dairy, cultured meat etc.). These smart proteins and functional foods have low carbon footprint, low environmental impact, promote animal welfare and have better food safety.
• Cell & Gene therapy: Advanced biomanufacturing will intensify India’s engagement in futuristic biotherapeutics techniques and personalized medicine such as cell & gene therapy, mRNA therapeutics, monoclonal antibodies. India has a potential to become global R&D and manufacturing hub for these technologies ensuring equitable access at scale.
• Agricultural transformation: Bio-manufacturing can promote soil-microbiome based research & analysis, selection process of superior microbial phenotypes, process for shifting microbial community composition towards desired/most beneficial microbial consortia, developing crop specific products for crop nutrition & protection and product formulation for enhanced stability. Thus, bio-manufacturing can enhance agricultural productivity, ameliorate the impact of climate change, ensure food security, promote improved crop varieties. 
• Addressing Climate Change: India has a set a target of achieving ‘Net-Zero’ status by 2070. Advanced biomanufacturing can help achieve decarbonization of hard-to-abate industry sectors and microbial conversion of captured CO₂ (carbon capture) into industrially relevant compound.
• Blue Economy: India’s large coastline and the resultant marine bio-resources can be harnessed to power India’s bioeconomy, ease pressure on terrestrial land for food production and as a source for bioactive compounds, enzymes and functional ingredients. 
• Long-duration Space Nutrition: Considering the unique challenges of nutrition for astronauts in long duration missions, bio-manufacturing can provide integrated, safe and nutritious meals for remote, austere locations or future-long duration space missions having long shelf life, low waste generation, good quality and safety.

Objectives of BioE3 Policy

• Intensifying research & innovation to address challenges such as mitigation of climate change and achieve decarbonization.
• Place India at the forefront of global biomanufacturing solutions.
• Boosting domestic biomanufacturing capability by enabling synergy between science, technology, engineering and manufacturing.
• Accelerating transition to biomanufacturing by promoting integrated use of AI and digitalization of ‘omics and upstream biotechnology interventions.
• Setting up facilities (biomanufacturing hubs/bio-fundary/bio-AI hubs) for scaling up and pre-commercial manufacturing, co-located with resources and infrastructure for fostering high-performance biomanufacturing.
• Nurturing cohort of highly skilled workforce.
• Harmonie regulatory reforms with global standards.
• Effective and transparent patent system for use of genetic resources.
• Promote sustainability in diverse ecosystems utilizing valuable knowledge of local communities.
• Harness regenerative bioeconomy with ethical and biosafety considerations.

Salient features of BioE3 Policy

1. Focus on six thematic sectors: Government will focus on the following 6 thematic sectors to achieve technology leadership.
   • Bio-based Chemicals & Enzymes
   • Functional foods & Smart Proteins
   • Precision Biotherapeutics
   • Climate Resilient Agriculture
   • Carbon Capture & Utilisation
   • Futuristic Marine & Space Research

2. Bio-enablers: Bio-enablers are catalysts that will accelerate discovery and translation research to enable biomanufacturing across the above 6 identified thematic verticals:
   • Bio-Artificial Intelligence (Bio-AI) Hubs: Bio-AI hubs will bring together experts from computation and biological disciplines leading to integration of AI & biological data in fields such as genomics, proteomics and medical imaging. These fields hold great promise for:
     • Advancing our understanding of biological systems.
     • Disease diagnosis and treatment
     • Drug discovery & personalized medicine
     • Synthetic biology: ‘Omics’ data on microbial, fungal and algal strains can identify novel metabolic modules with predictive molecular design principles guiding synthetic biology approaches to biomanufacturer high-value chemicals and biomaterials.
     • Agriculture: Bio-AI hubs can provide data analytics to improve farming practices, soil conditions etc. leading to lower costs and increased productivity.
   • Biomanufacturing hubs: They will comprise common usage/shared infrastructure of pilot and pre-commercial manufacturing facilities for researchers, startups and SMEs to support early-stage manufacturing, enable development & demonstration of applications and transform research leads into commercial products.
     • Biomanufacturing Hubs will engage private sector partners to ensure sustainability in investments and for leveraging private sector operating capabilities.
     • These hubs will be accessible to all strategic central agencies on need basis for providing technological and upscaling support on targeted products and applications.
     • These hubs will attract and retain high-skilled workers, act as training centres for skilled manpower, generate jobs and provide positive economic ripple effect.

3. Regulation & Global Standards: 
   • Regulations and global standards to be followed for creating an enabling environment for promoting R&D, scaling up and manufacturing, facilitating production and commercialization of novel bio-based products.
   • Regulations should be stringent considering the risks involved but ensure an increase in the pace at which products can reach the market.
   • This can be done by proactive engagement with all stakeholders, enhanced inter-ministerial co-ordination, seamless integration of biosafety & biosecurity considerations.

4. Data Governance Framework: 
   • Building of a data governance framework to promote AI-based discovery and maximise public benefit from data usage.
   • Discoveries, inventions and other knowledge arising will be made freely available to wider scientific community, while allowing protection of intellectual property.
   • Use of fail-safe mechanisms for due acknowledgement of data sources while ensuring equitable access to data.

5. Strategies for boosting biomanufacturing in India:
   • Undertaking discovery & application oriented integrated network research for developing advanced biosynthetic platforms
   • Bridging gaps between lab & market and scaling up through effective industry-academia collaborations.
   • Reducing costs, time and complexity in biomanufacturing innovation ecosystem by co-locating
   • Setting up ‘bio-enabler hubs’ to accelerate discovery and translational research across prioritised sectors. ‘Bio-AI hubs’ will enable discovery research across sectors. ‘Bio foundries/Biomanufacturing Hubs’ will support facilities for pilot scale and pre-commercial scale research.
   • Creating a large skill-set pool of trained manpower in domestic biomanufacturing.
   • Addressing regulatory roadblocks for biomanufacturing of genetically modified organism-based resources.
   • Partnerships and collaborations with potential stakeholders to synergies investments in biomanufacturing like international partners, research institutions, universities, governments, private sector etc.
   • Public-Private Co-Creation Model will be used to implement with policy that combines expertise in academia, start-ups and industry through inter-ministerial coordination.