An Industry Review of 2017 - Part 2
A Year of Investment and Outsourcing
Following on from the HPAPI upsurge, pharmaceutical manufacturers have had to invest in high potency facilities and equipment to deal with the associated risks. Some existing manufacturing facilities do not meet the necessary requirements to handle HPAPIs and there has been an increased need to upgrade or even construct new facilities to accommodate the intake of potent compound manufacturing.
This has been a big issue for smaller manufacturers who have struggled to invest in new equipment or upgrade existing equipment which is not always possible due to infrastructure, space or financial constraints. The cumulative effect has therefore led to an amplified demand for outsourcing. While production campaigns of high potent drugs can be small in volume, the can be highly lucrative particularly for smaller-scale, niche contract manufacturers (CMOs) who have positioned themselves perfectly to pick up the projects in this space.
Outsourcing has become a commonly found trend across the entire pharmaceutical industry and this is expected to continue into 2018 as the industry succumbs to the ongoing financial pressures and rising patient demand.
Another key trend over the last 12 months has again been driven by an increase in demand. The need to process sterile APIs and drugs, such as those used in oncology and injectables, have presented challenges due to the need for aseptic processing. This is because these compounds require all the parameters for sterile manufacturing whilst also containing the process from an operator exposure perspective.
Aseptic processing requires a closed system and naturally does not lend itself to open handling and operator interference. Open handling of sterile products in grade A cleanrooms is now being replaced by sealed transfers and barrier protection. These technologies have been gaining momentum for the last decade and are now actively encouraged by guidance documents and regulators as the safest approach in achieving a greater level of microbiological assurance. Techniques for sterile powder handling which historically were used in potent compound manufacturing are now being adopted in sterile manufacturing. This is particularly the case in the charging of solution preparation vessels, where sterile powder transfer valves are now being adopted instead of high level room grades, isolators or RABS.
There has also been a more considered approach in recent years to area classification on filling lines, creating RABs and isolator sections on the line instead of classifying the whole line as needing an isolator.
Overall the industry is also embracing a more automated approach by incorporating wireless monitoring technology. This type of technology will make it possible to receive integral equipment performance data quickly and easier than ever before. From here audits can be generated to allow for maintenance, health and safety and compliance teams in sterile manufacturing environments to consistently ensure that they have the highest level of product quality and operational safety. Such innovative technologies promise to revolutionise traditional containment strategies allowing manufacturers to meet the most stringent regulations and will be an exciting development to follow through 2018.