From patches to tablets and injectables to capsules, bringing new medication to the general public can incur costs of up to $2 billion. Innovative equipment, systems, and ideas can change the pharmaceutical manufacturing industry. These can improve upon the current technologies utilised to form medication and enhance the conditions and processes used to manage their development.
Continuous Manufacturing
Manufacturing in pharmaceutical production generally involves a multi-step synthesis of discrete batches, with transport and offline analysis occurring between steps. Conversely, a continuous process aims to integrate distinct operations into an uninterrupted flow. The trend towards continuous manufacturing enables greater efficiency, streamlining drug production from raw material to final product.
Integrated processes also ensure that such speed does not come at the cost of quality. Reducing the number of manual steps and transportation phases significantly diminishes the risk of error and contamination. Thus, continuous manufacturing enables manufacturers to realise uncompromised efficiency gains.
Process Analytical Technology (PAT)
Process analytical technology (PAT) is an important framework in the pharmaceutical industry, particularly with the growing inclination towards continuous manufacturing. PAT aims to design, analyse, and control pharmaceutical manufacturing processes. It measures critical process parameters (CPPs) that directly influence the critical quality attributes (CQAs) of the final product. This facilitates the real-time monitoring and optimisation of the manufacturing procedure.
It also significantly contributes to:
- Reducing production times and costs
- Preventing batch rejections
- Enabling real-time release testing
- Enhancing automation and control
Among its primary objectives, PAT aims to reduce production inefficiencies and enhance product quality by leveraging tools like:
- Multivariate data acquisition and analysis software
- In-line/on-line analytical instruments
- Continuous improvement
- Knowledge management systems
Data Integrity
The effectiveness of PAT and continuous manufacturing hinges on data integrity. This emphasises the necessity for accuracy, completeness, and reliability to ensure the quality and safety of products. Regulatory bodies, including the FDA and MHRA, have intensified their scrutiny of data integrity, mandating stringent data governance policies and procedures. This regulatory emphasis stems from past incidents where data integrity lapses resulted in product recalls, supply chain disruptions, and significant regulatory penalties.
The foundation of data integrity in pharmaceutical manufacturing is built upon the ALCOA principles. ALCOA stands for Attributable, Legible, Contemporaneous, Original, and Accurate, supplemented by ensuring data completeness, consistency, endurance, and availability. Adhering to these principles demands rigorous controls over the generation, processing, review, storage, and retrieval of data applicable to both electronic and paper-based systems.
Process Modelling
Process modelling is gaining prominence as a tool for enhancing the understanding, control, and optimisation of pharmaceutical manufacturing processes. This technological advancement employs various modelling approaches to simulate different unit operations and the comprehensive manufacturing process.
These include:
- Computational fluid dynamics (CFD)
- The discrete element method (DEM)
- Population balance models (PBM)
Adopting these models facilitates a deeper insight into process dynamics that are challenging to capture experimentally. These include internal shear forces and material segregation. Furthermore, process modelling is instrumental in transitioning from traditional batch processing to continuous pharmaceutical manufacturing.
This can enable manufacturing companies to:
- Refine process steps
- Economise operations
- Optimise production scheduling
- Design more effective facilities
Regulatory bodies, such as the FDA, endorse the use of process modelling alongside other Quality by Design (QbD) principles to elevate the standards of pharmaceutical manufacturing.
Through process modelling, companies can:
- Validate assumptions
- Identify critical process parameters
- Delineate the design space
- Meet key regulatory requirements
- Advance towards a more sophisticated, efficient, and compliant manufacturing paradigm
Precision Medicine
According to a survey, most industry leaders view precision medicine as a significant opportunity. 92% acknowledge its importance and 84% incorporate it into their corporate strategies. This strategic shift is anticipated to be the most impactful in oncology and orphan diseases, as cited by 91% and 53% of respondents, respectively.
Moreover, precision medicine is projected to reduce drug development costs by an estimated 17%. This translates to a global annual saving of around $26 billion.
The drive towards precision medicine is supported by the advancement of enabling technologies such as:
- Multi-omics profiling
- Digital biomarkers
- Model-based data integration
- Artificial intelligence
These technologies facilitate a more nuanced understanding of diseases, enhance patient stratification, and streamline the development of targeted therapies.
Essential to this approach are diverse data types, including:
- Clinical trial outcomes
- Electronic health records
- Genomics
- Real-world evidence
Utilising the Best Tools Can Enhance your Pharmaceutical Manufacturing Processes
PSL Powder Systems shares: "The overall aim of the pharmaceutical manufacturing industry is the wellbeing of patients. Creating a new medication has the potential to help a lot of people to cope with the symptoms of their conditions. State-of-the-art technologies can ensure the production process behind these medications works at its full potential. This is why we, Powder Systems, are dedicated to creating tools that can ensure your procedures are completely optimised.
Our portfolio of products contains technologies that can help you update your current practices. For instance, the MSR™ – Microsphere Refiner integrates PAT and helps with drug production by facilitating aseptic procedures for microspheres. Not only can this device support the recovery of products and the reproducibility of batches through the use of automation, but it can assist with the classification, washing, drying, and sampling of microspheres.
For commercial production, we have agitated nutsche filter dryers, specialised equipment that offers both filtration and drying. They follow Good Manufacturing Practices and are extremely versatile, meaning they can undertake batch processing or even be the final step in continuous manufacturing. We also have simpler equipment available for drying, such as our Cakestand™. Although the principles behind this product are more basic, it utilises an energy-efficient design and shelves with direct heating to refine the drying process. We even have software available for our Cakestand™, the PSL Automation Platform, to ensure that certain parameters utilised within a procedure can be recreated.
You have the opportunity to enhance your current manufacturing equipment and ensure that your products are the best they can be. Contact Powder Systems now and learn more about our available technologies for pharmaceutical manufacturing and how they can be applied in your own procedures."
