Sector highlights: ChargePoint Technology interview
Michael Avraam, global product manager at ChargePoint Technology for the PharmaSafe range of products, gives us a rundown of his sector highlights of 2017.
1. What has been the biggest opportunity of 2017 for your company/organisation?
In early 2017, we invested in new manufacturing machinery at our UK facility in Liverpool to meet increased demand for larger diameter valves for use in large scale drug manufacturing that requires containment. The new 5-axis machine is the first of its kind in the UK and forms part of a wider £1million investment into advanced manufacturing capabilities at our HQ. It will enable ChargePoint Technology to speed up the production and delivery of larger diameter valves up to 250mm (10”).
The investment has been made in response to growing containment demands that are being driven by growth within therapeutic areas, including oncology and hormonal drug products. This is leading to increased volumes of high potency active pharmaceutical ingredients (HPAPIs) being used in the production of tablets, capsules and other solid dosage forms. This demand further fuelled the need for our expansion into North America, with our new office opening in San Francisco mid-year.
Growing our North American presence is a significant milestone for us and reflects our strategic vision to expand the company in key markets meaning that we are ideally placed to meet the increasing demand for safe containment and sterile transfer solutions.
More recently, we achieved the highest level of certification in Atmosphere Explosive (ATEX) and International Electro Commission (IEC) Explosive (Ex) equipment which has enabled us to continue to develop and offer superior containment solutions worldwide.
This external certification is recognition of the work that we have put into supplying products suitable for use in the most stringent hazardous environments and will form an important part of our future product development plans.
2. In your opinion, what has been the most important innovation for the year?
As the industry is embracing a more automated appraoch by incorporating wireless monitoring technology, it will be possible to receive vital equipment performance data and generate an audit trail much easier and quicker. As a result, maintenance, health and safety and compliance teams in high potency manufacturing environments can ensure the safer and contamination-free handling of API and other formulation ingredients, offering the highest levels of operator protection and product quality.
Such innovative technologies promise to revolutionise traditional containment strategies allowing manufactures to meet the most stringent regulations.
3. Which factors have driven the biggest changes to the industry in 2017?
The biopharma market is continuously expanding, thanks largely to the global demand and growth in the oncology market which has led to an increased need for the development of potent compounds and an increase in conventional drug manufacturing using high potency APIs (HPAPIs). This creates the need for advanced control strategies in high potency manufacturing to address both the quality of the final product and, critically, operator safety.
4. What market trends have been influential for 2017?
Market diversification has meant that more innovative technology developments, including isolators, restricted access barrier systems (RABS) and split butterfly valves (SBVs) have entered the market, which are all now commonly used throughout the manufacturing process to address the containment demands when handling potent compounds.
Other containment solutions such as isolators can be integrated with closed transfer valves like SBVs to enable the safer transfer of potent compounds and can be used in many applications when, not only dust control and containment is a concern, but where product flow, yield and sterility are also important. The technology reduces the presence of airborne dust particulate, ultimately lowering the risk of cross contamination and protecting operator safety.
5. What have been the biggest challenges of the year?
In an industry that is seeing a surge in oncology and immune-suppressant therapies, and increasing demand for HPAPIs, there is a growing need for manufacturers to look at more innovative containment strategies to meet high potency handling requirements. In this environment, ensuring operator safety, alongside protecting the drug product to avoid cross contamination (particularly in the case of aseptic processing), is a challenge that must be addressed.