Demand for high potent active pharmaceutical ingredients is driving the need for high potency handling capabilities. Here, Mike Avraam, global product manager for ChargePoint PharmaSafe, ChargePoint Technology, discusses this growing sector in detail in this Q&A.
Highly potent
1. What is driving the need for more high potency capabilities?
Global demand and growth in the oncology market, including the development of antibody drug conjugates — ADCs, and an increase in conventional drug manufacturing using high potent active pharmaceutical ingredients (HPAPIs) is driving the need for high potency handling capabilities, particularly high-containment manufacturing facilities.
2. What challenges face manufacturers developing high potency products in their facilities?
Handling of these ingredients in the drug supply chain is the primary concern, where specialist equipment should be employed to avoid cross contamination, product protection and to ensure operator and environmental safety.
One of the biggest challenges is choosing an appropriate solution based on a wide range of requirements. It is a matter of finding a balance that prioritises protection whilst maintaining productivity and operability.
Also, extending capabilities can mean upgrading/investing in new equipment — a significant challenge for smaller manufacturers.
3. How have manufacturing facilities for potent compounds changed over the past decade?
Lots of new technologies have entered the market but some primary go-to solutions remain. The main change has been how these solutions have advanced, offering higher levels of protection and less reliance on personal protection equipment (PPE) and respirators.
4. What current technologies are available to help minimise the risks associated with potent compounds?
There are several technologies that can help minimise the risks associated with potent compounds. For example, rigid and flexible barrier isolators offer a very good level of containment security, with the design and correct operation being key to maintaining appropriate containment performance.
Ideal for handling larger process operations, extracted booth technology offers a secondary level of containment protection, however it does also require a high level of PPE.
New design technologies to remove the risk of airborne exposure have been pivotal in achieving high containment. Split butterfly valves have evolved over the last 25 years to meet the increasing demand in containment performance of potent compounds. These can be integrated with many other containment solutions to enable the transfer of potent compounds.
5. What are some of the handling challenges and how can they be overcome?
The increasing use of HPAPIs presents handling challenges and the need to invest in containment equipment to protect employees and the environment from exposure.
One of the biggest challenges is establishing and selecting the correct containment solution to suit the process operation. The selection, specification and compatibility of materials also has an important role to play.
The correct installation and set-up of the solution is of primary importance, as this will support employees in the safe and proper handling of the equipment. Additionally, training is essential alongside monitoring of operating methods to ensure maximum protection.
Frequent maintenance also helps safeguard the reliability of the solution.
6. How is the growing demand for HPAPIs impacting the outsourcing sector?
Some existing manufacturing facilities do not meet the necessary requirements to handle HPAPIs and there is an increasing need to upgrade, develop and even construct new facilities to accommodate the intake of potent compound contract manufacturing.
Manufacturing facilities need to be designed and dedicated to certain production processes that can adapt and cater for varied production volumes. An increase in varied, validated manufacturing processes can also require investment in associated bespoke equipment technology. While production campaigns of high potency drugs can be small in volume, they can be highly lucrative particularly for small-scale niche CMOs and CDMOs.
7. What qualities should manufacturers look for in outsourcing partners?
Manufacturers should look for experienced outsourcing partners who have a track record of success. A considered approach to managing risk and validation of equipment should be a key consideration, this is particularly important when working with HPAPIs where health and safety is paramount. A partner that can demonstrate flexibility in their solution will also be important as business priorities change and when scaling up production, reacting promptly to meet the demand is essential.
8. In your opinion, what does the future hold for high potency facilities?
Technological advances will drive future change in all manufacturing facilities. Given the risks involved with operator exposure to high potency drug products, however, there are certain technologies that we can expect to eliminate the potential risks — namely the use of robotics that will remove the operator from physically working with harmful substances.
In the same vain, automated systems are already in operation across many facilities but this is likely to increase as processes become more integrated and Industry 4.0 really starts to take a hold.
As the demand increases for high potency drugs and developments in biotechnology occur, there is the potential for closed systems to be developed to further protect operator and environment safety, however this will coincide with a reduction in production volumes.