Drug manufacturing makes up a significant part of what it costs to develop drugs. As expenditures for ingredients, power, equipment, rent and staff increase, companies are working hard to find ways to cut outlays through streamlining. It's not just about money, though – making manufacturing more efficient reduces waste, gets drugs to patients more quickly and combats drug shortages.
Adding automation and robotics
Manufacturing can involve hundreds of steps and many repetitive processes, and these need to be carried out efficiently, accurately and reliably to reduce error, improve quality, maintain batch consistency and keep patients safe. Using automation reduces the chance of mistakes and allows processes to be integrated. Automation supports the safety of manufacturing staff by tracking personal protective equipment (PPE) and monitoring climate. It also helps companies meet regulatory standards. [1]
Robotic process automation (RPA) is a key part of automation in pharmaceutical manufacturing. Robots can handle active pharmaceutical ingredients (APIs), including high potency APIs, protecting staff from harm. Using robotic technology also reduces the risk of microbial contamination by operators, particularly important for sterile products produced in isolated environments, and for therapeutics used in highly vulnerable patients. Robotic production lines can also check for inaccuracies and errors in filling and packaging, and make corrections or reject products. Some equipment can allow an operator to intervene robotically from outside an isolation unit to make a correction, change a filter, clean up broken glass or fix a jam without breaking the barrier. [2]
Process analytical technologies (PAT) can be integrated into production, reducing the need for manual sampling, freeing up the time required to send samples to external laboratories, cutting the number of rejected batches and allowing continuous improvements in processes. As well as in-line/on-line analytical instruments, PAT tools include multivariate data acquisition and analysis software, and knowledge management systems [3, 4]
Batch and continuous manufacturing
Traditionally, pharmaceutical manufacturing has been carried out in batches. The batch release quality assurance process involves testing and accurately documenting a batch of drugs, which is then certified. Because this focuses on accuracy, it can reduce errors, ensure smoother workflows and improve compliance with good manufacturing practice (GMP) and regulatory guidelines. However, the sops and starts between batches can cause delays.
There are processes that can streamline batch release: [5]
Standardising documentation to ensure consistency and clarity
Automating data collection to minimise errors and save time
Training staff and keeping them updated
Carrying out internal audits to identify inefficiencies and gaps, and correct errors early
Using digital tools to track the manufacturing process in real time
In continuous manufacturing, materials are constantly fed into the production process, and products are continuously removed. This means that production lines can run continually around the clock. By cutting the downtime between steps, continuous manufacturing can make the manufacturing process faster, more efficient and more cost-effective compared with batch manufacturing. Fewer manual steps are required, so the risk of error and contamination is reduced. The flexibility means that quantities of product can be adjusted by making changes to process runtime or ingredient flow rates, reducing the need to maintain high levels of inventory and therefore cutting storage needs. Continuous production lines are often smaller, so manufacturing plants can take up less space, or manufacturers can fit in more lines into the same area. [4, 6, 7]
Using continuous manufacturing can cut operating costs by h...
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