Express Pharma

Demystifying pharma science: Batch v/s continuous manufacturing – choosing the right approach

By Indu Bhushan, CEO & Director, STEERLife

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The rise of India’s pharma sector:

The Indian pharmaceutical sector has a significant influence on human well-being and continues to play a key role in supplying drugs and vaccines to millions around the world. The industry is poised for sustained growth and is expected to reach $65 billion in 2024 with forecasts pointing toward a remarkable growth of around $139 billion by 2024 and $450 billion by 2047. (Source: EY). 

India is a major exporter of pharmaceuticals, with over 200+ countries/territories served by Indian pharma exports. India supplies over 50 per cent  of Africa’s requirement for generics, ~40 per cent  of generic demand in the US and ~25 per cent  of all medicine in the UK. (Source: Invest India) India currently commands over 20 per cent  of the global generics supply by volume and addresses approximately 60 per cent  of the worldwide demand for vaccines. (Source: EY).

Over the years, India has undergone a remarkable transformation in this sector and have evolved into a dynamic powerhouse of healthcare advancements worldwide and will continue to shape the trajectory of healthcare in the times to come. The sector is poised for further expansion and transformative shifts with significant opportunities and several challenges that lie ahead. The government supported production-led incentive schemes not just for formulations, but also bulk drugs, drug intermediates, and the Meditech sectors are the rising sectors of our economy. Beyond its global impact in improving health outcomes, the Indian pharmaceutical industry plays a pivotal role in propelling the country’s economic growth and generating employment.

Let’s dive deeper to understand batch manufacturing & continuous manufacturing and which approach best fits your business needs.

 

Understanding Batch Manufacturing:

In batch manufacturing, drugs are produced in discrete steps or batches. This process involves mixing the ingredients, processing them, and then packaging the final product. Each batch is made separately, with its own set of equipment and conditions. While it has been the norm for decades, it comes with certain limitations:

  • Inefficiency: This happens between the start and stop of any particular batch
  • Quality variability: Each batch may vary in quality due to differences in equipment usage and operator techniques
  • Scale-up challenges: Scaling up is complex and time-consuming, requiring adjustments to equipment and processes to maintain product consistency
  • Inventory Management: Batch processes lead to large inventories of intermediate and finished products, which may lead to potential expiration or obsolesce
  • Costs: Costs of labour, power, and production times are significantly higher
  • Environmental Impact: BM may result in higher energy consumption and waste generation than continuous processes.

Despite its limitations, batch production has a wide adoption rate because of its familiarity, lower equipment cost, and relatively lower failure rates.

 

The shift:

Continuous manufacturing revolutionises the pharmaceutical industry by enabling a seamless flow of production from raw materials to finished products without the need for batch intervals. In this approach, ingredients are continuously fed into the production line where multiple stages of production occur in a continuous stream. The constant flow allows for real time monitoring and control of various parameters such as temperature, pressure and composition ensuring consistent product quality and uniformity.

Key components include integrated processing units interconnected by automated control systems that regulate critical process parameters within a narrow range of operation.

Continuous manufacturing revolutionises the pharmaceutical industry by enabling a seamless flow of production from raw materials to finished products without the need for batch intervals. In this approach, ingredients are continuously fed into the production line, where multiple stages of production occur in a continuous stream. The constant flow allows for real-time monitoring and control of various parameters such as temperature, pressure and composition, ensuring consistent product quality and uniformity.

Key components include integrated processing units interconnected by automated control systems that regulate critical process parameters within a narrow range of operation.

 

Significant advantages of adopting continuous manufacturing:

  • Improved Product Quality: Due to only nominal changes required in continuous manufacturing there is greater quality control leading to improvement. 
  • Improved Efficiency: Continuous manufacturing eliminates the need for batch setup and cleaning, leading to reduced downtime and increased production efficiency.
  • Consistency: The continuous nature of the process ensures that each batch of product is consistent in quality, with minimal variation.
  • Real-time Monitoring: Continuous manufacturing systems are equipped with sensors and monitoring devices that allow for real-time monitoring of critical parameters such as temperature, pressure, and flow rates. This enables rapid detection and correction of any deviations from the desired conditions.
  • Flexibility: Continuous manufacturing systems are highly flexible and can easily accommodate changes in production requirements or formulations.
  • Reduced Waste: Continuous manufacturing generates less waste compared to batch manufacturing, as there is no need to discard leftover materials between batches.
  • Cost Saving: Continuous manufacturing reduces downtime and increases production efficiency by eliminating the need for batch setup and cleaning. This results in cost savings and faster time to market for pharmaceutical companies.

The other side of the ‘benefit’ coin lies the challenges. Everything comes with a set of challenges. For continuous manufacturing, they are:

  • Initial Investment: The initial investment required to implement continuous manufacturing can be significant, as it involves the installation of specialised equipment and infrastructure.
  • Regulatory Approval: Regulatory agencies may require additional validation and documentation for continuous manufacturing processes, which can prolong the approval process.
  • Transitioning from Batch to Continuous: Transitioning from batch to continuous manufacturing may require reevaluation of existing processes and workflows, as well as staff training on new technologies.
  • Risk Management: Continuous manufacturing systems are highly automated, which increases the risk of system failures or malfunctions. Robust risk management strategies are essential to mitigate these risks.

With its promise of faster, more cost-effective production, continuous manufacturing will continue to evolve and gain acceptance. More pharmaceutical companies will keep adopting it for the production of a wide range of drugs, nutraceuticals, and food products. Despite challenges, continuous manufacturing is poised to revolutionise the pharmaceutical industry. Its ability to improve efficiency, consistency, and flexibility makes it an attractive option for pharmaceutical companies looking to stay competitive in today’s fast-paced market. 

 

Comparison Chart: Batch Manufacturing VS Continuous Manufacturing 

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