Great opportunity lies ahead for the Indian pharmaceutical industry. Today India supplies 40% of the US demand for generic medicines, 25% of all medicines consumed in the UK, 50% of various vaccines used internationally and 80% of the global supply of antiretroviral HIV therapeutics. Furthermore, the Indian Economic Survey 2021 predicts that the domestic pharmaceutical market will grow threefold in the next decade.
One key factor is the growing demand for generics in response to the increasing incidence of chronic diseases worldwide. Indian pharmaceutical companies continue to help meet this demand by proactively building high capacity production facilities across the country that are increasingly compliant with the standards specified by global agencies such as the USFDA and EMA. This is also actively encouraged by the Indian government through its Production Linked Incentive (PLI) program.
Simultaneously however, the industry faces significant challenges. Most recently, the combined effects of both the COVID-19 pandemic and nitrosamine impurity crisis helped create a perfect storm for unprecedented global supply disruptions for pharmaceuticals. In response, governments and consumers the world over are demanding reliable supply of high-quality medicines at affordable prices. The good news is that with its well-establish pharmaceutical production network and strong science and engineering workforce, India is well-positioned to make a significant contribution and, in the process, to grow its reputation and footprint globally. Nonetheless, to realize this potential there are specific challenges that need to be prioritized.
A longstanding challenge is to gain tight control of pharmaceutical operations at both brand pharmaceutical companies and contract manufacturing organizations (CMO’s) to ensure that high product quality can be consistently delivered with stable production capacity at minimum cost. This capability needs to be further developed by Indian pharmaceutical manufacturers and also clearly demonstrated, both to international regulators and prospective customers. With more compelling evidence that a producer delivers consistent quality and supply reliability comes greater success against competitors for global sourcing contracts of either intermediate pharmaceutical materials (e.g., active pharmaceutical ingredients, API’s) or finished pharmaceutical products (FPP’s).
Process Analytical Technology (PAT) is a spectrum of synergistic technologies that address this need. PAT can, in effect, put the laboratory testing “in a box on the shop floor”. Advanced spectral instruments such as Raman and Near infrared (NIR) are inserted into the process to directly probe the product in real-time. This is coupled with state-of-the-art spectral analysis software that enables product quality to be calculated with high frequency and precision. This technology provides compelling benefits. Firstly, non-destructive, 100% product quality inspection is achieved. This enables the producer to certify the quality of every lot of product with confidence and full traceability. Secondly, the immediate quality feedback enables on-specification product to be shipped to customers without delay, compared to having to hold the product for days or weeks while the laboratory conducts testing. Consequently, the producer achieves greater responsiveness to market demand and reduces inventory management costs.
Another high-value benefit is enhanced visibility and control. For example, GE Healthcare was able to use online product quality measurement with a Raman spectrometer, together with multivariate process modeling, to accurately determine the specific endpoint for each batch. Every batch is now terminated at the unique time that optimally trades off maximizing yield with keeping the buildup of impurities below an acceptable threshold. This eliminates a recurring problem of batches being out of specification for impurities. As a result, the company has saved US$300,000 per lost batch avoided and has improved scheduling reliability. In general, direct quality measurement together with multivariate process monitoring and control enables variations in raw material quality, day-today variability in weather, and operatorto- operator differences to be detected, understood and compensated for, resulting in more consistent high-value outcomes for every batch.
Key PAT enabler technologies from Aspen Technology High performance data acquisition, storage and retrieval with Aspen IP.21 Real-time data trending, visualization and analysis with AspenONE Process Explorer Structured workflow management and visualization with Aspen Enterprise Insights Spectral instrument and multivariate product quality analysis and monitoring with Aspen Unscrambler & Aspen Process Pulse Process data modeling, troubleshooting and optimization with Aspen ProMV Closed-loop predictive control of continuous processes with Aspen DMC Closed-loop predictive control of batch processes with Aspen Batch APC
Aspen Technology is a global leader in Industrial AI technology with a 40- year history of helping customers in the process industries accelerate their digital transformations to design, operate and maintain manufacturing processes that run safer, greener, longer and faster. Today AspenTech has more than 2300 customers worldwide, driving more than US$50 billion in annual value created. Sixteen out of the twenty largest pharmaceutical companies use AspenTech solutions as do all twenty of the largest chemical companies.
AspenTech delivers a rich technology stack for PAT as summarized in the table above.
Leading pharmaceutical companies, including Lonza, Bayer, Avara and Vistin Pharma, use Aspen Process Pulse as their real-time product quality platform. Dr. Tobias Merz, Director of Global Operational Technology at Lonza commented, “As a contract manufacturer, it is important to be flexible and open to new technologies. The implementation of a PAT data management solution with Process Pulse allows us to build process knowledge from the beginning of a new process development and close the gap between R&D and production.”
AspenTech’s implementation partners, India included, help scope and deliver the best-fit PAT solutions for their customers’ most pressing business challenges around attaining consistent quality, yield and throughput. This implementation coaching and support helps customers succeed early, scale quickly and make the decision to either build in-house capacity for continuing to nurture or advance these PAT systems or to outsource this function to the expert solution provider.
Accelerate your company’s growth in the pharmaceutical industry by harnessing the full power of PAT for continuous process improvement and real-time product quality certification. Gain key insights on how to progress PAT in your company with this webinar from AspenTech.
