Pharmaceutical manufacturing is experiencing a period of rapid innovation. Even as GMP compliance remains the foremost concern, manufacturers are finding new and creative ways to create value in highly regulated contexts.
Here are the processes, products, and digital technologies defining the drug production landscape in 2019 and 2020.
Personalized medicine, also called precision medicine, is a method of diagnosing and tailoring therapies to individual patients based on their predicted response to treatment.
With precision products passed the clinical stage and on the market, there are good indicators that personalization will increase in the years to come. Investment in personalized medicine has doubled in the last five years, and recent market research predicts the production of precision therapies to increase by 33% by 2025.
The emergence of personalization has several implications for manufacturers, as personalized batches are inherently small, and may require several treatment variations.
It signals a several shifts manufacturers should note:
- Smaller production runs, making agility essential for creating value
- Production schedules conforming to a made-to-order basis
- The increased use of CMOs to lower costs and meet demand
- The use of smaller, specialized facilities better poised to meet demand than larger, high-volume factories.
Low Volume Production
Personalization isn’t the only trend contributing to the expansion of low-volume production in drug manufacturing. It reflects an industry-wide shift from low-cost drugs applicable to a large population to high-value, targeted therapies.
Low-volume production helps get life saving drugs to patients, but it can complicate the manufacturing process.
Besides involving complicated syntheses and production processes, low-volume drugs face the same GMP validation process as high-volume drugs. Collecting the requisite batch data to satisfy compliance can hurt margins when there are fewer total batches. And navigating complex supply-chains is more difficult when the life-cycle of a drug is shorter.
Maximizing profits on small runs will require fast set-up of production lines, accurate collection of batch data, and agility to respond to changing product demands.
Digitization of Paper Processes
Technologies like AI, AR, and IIoT might steal the headlines, many manufacturers realizing significant gains by beginning their digitization with paper processes.
Manufacturers can institute electronic logbooks, digital batch records, and interactive digital SOPs to improve visibility and efficiency with little upfront investment.
By replacing paper-based processes with digital ones, manufacturers can make compliance a seamless part of the manufacturing process, eliminate data loss and transcription errors, and improve operational efficiency.
Growing Embrace of the Cloud
With improvements in security and cost, pharmaceutical manufacturers are adopting cloud computing and storage in force.
Cloud infrastructure is an essential first step toward expanding IIoT capabilities, and it makes ensuring data integrity and sharing across a product’s lifecycle easier.
Particularly, the growth of Platform as a Service offerings has given pharmaceutical manufacturers the opportunity to build, configure, and iterate GxP compliant applications while ensuring all development is contained to a tightly controlled environment.
Continuous manufacturing is continuing to grow as an alternative to batch production. Continuous manufacturing speeds production, reduces the likelihood of human error, and can reduce the need for multiple facilities.
While still an emerging technology, the continuous manufacturing market is expanding at a rate of 13% a year.
Big Data for Preventative/Predictive Measures
In the ISPE’s Pharma 4.0 maturity model, the end-goal of digitization is “smart facilities”–drug production facilities where systems respond to changes in real-time and instigate the necessary corrective actions.
This level of digital maturity may not be on the immediate horizon, but many manufacturers are beginning to explore predictive quality techniques.
Fulfilling the promise of predictive quality requires facility with large data sets, data that accurately and cleanly reflects production, and facility with AI and machine learning.
Manufacturers interested in implementing predictive quality can start by clarifying the questions they would like predictive algorithms to answer and establishing the infrastructure necessary to collect good data. As we’ve written before, predictive maintenance isn’t just an AI problem.
Digital Technologies for Pre-Production Training
Quickly training staff to perform complex tasks in a highly regulated environment is an essential maximizing value. Increasingly, pharmaceutical manufacturers are turning to digital applications to drive their training programs.
These applications break multi-step processes into digestible modules improving retention and speed. Applications can simulate real production processes, letting workers train on ecologically valid working scenarios. Further, because the applications collect data as if they were running during production, manufacturers have an opportunity to make important adjustments to improve efficiency before going live.
Single Use Technologies and Facilities
As the cost of opening large-scale production facilities remains high, many manufacturers are choosing to “scale out” rather than scale up.
Single-use facilities are an increasingly attractive solution to high, especially for pre-clinical and clinical manufacturing.
These new facilities offer more capabilities than traditional facilities at a fraction of the cost.
They are multi-product facilities that incorporate disposable, single use technology in place of
stainless steel and hard piped equipment.
Summary of Trends
On the whole, pharmaceutical manufacturing is experiencing a move toward lower volumes, faster product runs, higher product mixes, and increased digitization.
The manufacturers that succeed in this landscape will be those that find ways to increase operational efficiency and agility.
Luckily, there are more technologies and tools available than ever to help manufacturers grow the bottom line and improve patient outcomes.
If you’re ready to improve the digitization of your pharmaceutical manufacturing facilities, get in touch for a free consultation with Tulip’s pharmaceutical industry experts.