For pharmaceutical and biopharma companies, building quality into your products from an early stage is a key factor in regulatory approval and market success. Design of Experiments (DOE) is an essential tool for achieving both regulatory compliance and faster time to market.
Over the last several years, the use of artificial intelligence (AI) in the pharma and biomedical industry has gone from science fiction to science fact. Increasingly, pharma and biotech companies are adopting more efficient, automated processes that incorporate data-driven decisions and use predictive analytics tools. The next evolution of this approach to advanced data analytics incorporates artificial intelligence and machine learning.
In the midst of a global COVID-19 pandemic, a top priority for many pharma and biopharma companies is to get a vaccine developed, produced and delivered to the public as quickly as possible. Ushering a vaccine through rigorous testing protocols and regulatory approvals is not an easy (or quick) effort, but incorporating advanced data analytics could help accelerate the process. Data analytics has proven effective in speeding vaccine development both by enabling more efficient Design of Experiments (DOE) and by creating rapid-scale production rollout processes.
Digital transformation in biopharma promises to deliver exponential results and make new discoveries and solutions to complex problems a reality, but it requires companies to make big changes to get there—changes in processes as well as adoption of new technologies. For some companies and facilities, this is a bigger leap than for others. Depending on the level of digitalization and integration that currently exists within a company, the process can take from months to years.
Digital transformation in biopharma, like other industries, is accelerating as Pharma 4.0 and Industry 4.0 begin to take shape in companies of all sizes. But knowing that digital transformation is inevitable is one thing, successfully managing the transition process is another. What are the steps biopharma companies should be taking to ensure a smooth digital transformation?
From employing artificial intelligence (AI) to identify drug candidates to using big data to support continuous process manufacturing, the prospects for digital transformation in the biopharma industry are huge. Yet, biopharma and life sciences lag behind many other industries when it comes to digital transformation.
Out of control processes in pharma manufacturing are not something to take lightly. If your production runs are seeing frequent deviations, leading to expensive batch losses or frequent rework, it’s time to take a look at ways to correct any process deviations in a more expedient manner. Uncorrected deviations or processes that vary from approved process parameters can lead to costly and dangerous mistakes.
Keeping your pharmaceutical manufacturing processes under control is important not only to ensure a quality product, but also for regulatory compliance. Process or raw material deviations can affect the downstream quality of a product and could mean tossing out an entire batch or end product if process corrections aren’t made soon enough — or if you can’t document that a correction was made before it affected your critical quality attributes.
For pharmaceutical manufacturers, a process deviation may not only mean a bad batch that affects a downstream process, it can also risk a regulatory violation that leads to fines or expensive market setback, or worse, it could endanger the health of the patient.
Using Multivariate Models in a Regulated Environment for Continuous Manufacturing of Pharmaceuticals
Continuous manufacturing is one of the key trends within the pharmaceutical industry, both for the production of ‘classical’ drugs as well as large molecules. Companies are looking for ways to shift from traditional batch processing to a continuous method of operation. The main advantages associated with these processes are more room for modularity, automation and flexibility due to a smaller footprint, as well as more consistent quality of the drug product.
For pharmaceutical companies facing challenges such as rising costs, sterner regulations and declining profit margins, innovative new technologies like artificial intelligence (AI) and digital twins have become part of an essential strategy to future-proof their businesses. A digital twin is the next evolution of machine learning combining advanced data analytics and equipment simulation with comprehensive system models that blend historical information with real-time data to predict the future of a process. According to Gartner, the digital twin concept was one of the top 10 strategic technology trends in 2019.
Biosimilars are an exciting route to increasing access to the highly effective therapy made possible by biologics, but ensuring a biosimilar meets the critical quality attributes (CQA) of the original biologic is a major challenge. Optimizing production at full scale is impractical, which makes a quality by design (QbD) approach using a reliable scale down model of the process an attractive alternative. A process development team at Zhejiang Hisun Pharmaceuticals, Taizhou, China, therefore developed a scaled down model of the cell culture process used to produce the biosimilar adalimumab. They qualified the model using multivariate data analysis (SIMCA), and explored the design space for key process attributes (KPA) and CQAs using MODDE.
