For pharmaceutical and biotech manufacturers, trends in the market place are driving changes in the way they have historically operated their production processes.I caught up with Emerson’s Michalle Adkins who shared these trends with me. She identified six major areas: continuous manufacturing, single use technology, biosimilars & generics, personalized medicine, demographic shifts, and taking advantage of emerging technologies from the Industrial Internet of Things often seen as a significant part of “Pharma 4.0”.
The process to make medicines and other pharmaceutical products has traditionally been batch-based. Continuous processes, common across many other industries have the advantage of allowing smaller facilities to be built with lower capital costs required. New processes can be tested using Design of Experiment techniques in rapid-fire success to vary operating conditions, come to steady state, and sample the process to determine optimum operating conditions for the product and gain process and product knowledge.
Operating continuously also reduces the cost of goods sold with less work in process inventory, more efficient energy usage, and less waste. The quality of the products being produced can also be continuously monitored to identify and correct excursions before they surpass quality limits. A continuous process is also reliable and flexible to respond to changes in market conditions.
While there are several advantages, there are also a number of challenges. Shutdowns, startup, continuous monitoring and the control strategies must be thoughtfully considered and implemented. With the requirement for continuous quality monitoring, development of systems integration and data analysis methods must be designed.
Since materials are continuously fed into the process, material traceability becomes more complex and meeting the regulatory requirements and approvals takes careful planning. Advancements in process monitoring, control system and process analytical technologies as well as Quality by Design practices make the movement to continuous processing more possible. The benefit is production in minutes instead of weeks as well as a smaller, more modular facility.
Single-Use (SU) technology continues to advance because it decreases plant capital expenditures, increases process efficiency, reduces cross-contamination risks, improves scheduling timelines, decreases plant footprint, and reduces utilities consumption including water, steam, and energy. Many products in development are for smaller markets whether niche markets or personalized medicines.
The challenges to single-use technologies are that there are higher operational costs for disposable components such as processing bags, tubing, instruments, etc. Facilities with single-use equipment also are more likely to have limited capacity and standardization is more difficult to achieve. Technologies continue to advance to provide streamlined instrumentation and scalable systems and software to meet the requirements for single-use equipment.
Michalle noted that as the genetics field has advanced, personalized medicine has become more feasible. Managing many small batches, all aspects to ensure control of a patient-specific batch, and varying growth rates are some of the challenges that are being addressed now. From a technology and expertise perspective, electronic data management and methods to ensure right first time actions will be critical. Closer partnerships between Life Sciences manufacturers and automation suppliers will become even more important to address the regulatory hurdles.
The move from mass production to smaller, shorter run individualized products, and changing technology is prompting a rethink, Pharma 4.0, of the manufacturing and quality processes. The supply chain also is growing more complex as elements in the product development and production processes are outsourced geographically.
Michalle highlighted the fact that technology advancements, expertise and work processes can help address some of these challenges. Cloud-based data management provides access for cross-functional teams along with the use of advanced analytical tools to facilitate and perform real-time corrective actions. The Internet of Things enables a wider breadth of sensors to be easily added to eliminate blind spots and get the right information to the right expert.
You can connect and interact with other pharmaceutical and biotech manufacturing experts in the Life Sciences group in the Emerson Exchange 365 community.