European Pharmaceutical Manufacturer speaks to some of the leading names in pharmaceutical manufacturing to find out what the key moments have been for them in 2018.
Jonathan Gaik, director, Natoli Scientific, Natoli Engineering
One of the biggest pharma breakthroughs this year happened when the FDA approved its first product derived from marijuana. The product is an oral solution containing cannabidiol (CBD) but the FDA was careful to stress that this approval did not translate into approval of marijuana or its other components. Many small companies make products that contain CBD, and they are starting to look at manufacturing CBD tablets. However, a lot of companies who want to make tablets have little or no experience with oral solid doses. Manufacturers are being presented with a huge opportunity to work with CBD companies as they move into tablet production.
Stacey Vaughan, senior director, strategic marketing, pharma, West Pharmaceutical Services
West is seeing notable requests for components supplied in port bags indicating that more companies are transitioning to fully enclosed isolators, restricted access barrier (RAB) or closed systems. In concert with this request, the European Medicines Agency (EMA) Annex 1 “Manufacture of Sterile Medicinal Products” has given the industry further guidance on use of barrier technologies. While there is no direct requirement for manufacturers to use it, the Annex infers by the statement “RABS, isolators or closed systems, should be considered in order to reduce the need for interventions into the grade A environment and minimise the risk of contamination” that barrier technology should be being adopted.
Ettore Cucchetti, CEO – ACG Inspection
The track & trace industry is currently going through a complete overhaul, in light of the EU FMD regulations. The approach of a centralised repository with localised verification data centres is well-thought through. ACG Inspections foresees technologies like blockchain, IIoT and machine learning playing a key role in securing the pharmaceutical supply chain from counterfeit goods. And we expect that – in future – all countries will come together to standardise track & trace implementation and information exchange. Track & trace will move from a need to have the technology to must-have technology in the complete pharmaceutical production.
Tim Freeman, managing director, Freeman Technology
A significant focus of the pharmaceutical industry continues to be the strive to understand the impact of material properties and process parameters on product quality attributes. Both off-line and in-line measurement techniques can be utilised to support scientists and engineers in this task, but it’s imperative to ensure the most suitable properties are measured. The potential benefits of continuous manufacture have been widely discussed, and accepted, however in this environment, where residence times in a given process operation may be measured in seconds, a robust knowledge of all relevant material and process variables is even more important. Great progress has been made since the introduction of quality by design (QbD), but there is still knowledge to be further acquired.
Dr Andreas Mattern, director product management pharma, Bosch Packaging Technology
The pharmaceutical industry is witnessing important developments in biological agents, for instance for the treatment of cancer or orphan diseases. These call for flexible equipment that can handle ever smaller batches, while adapting to new products and packaging formats quickly. Moreover, the development of continuous manufacturing equipment for oral solid dosage (OSD) is opening new potential for optimum API dosage and faster time-to-market. 2019 will also see an increase in industry 4.0 solutions especially adapted to the strict regulations of the pharmaceutical industry.
Ben Wylie, senior product manager, Chargepoint Technology
Increased demand for drug manufacturing using high potency active pharmaceutical ingredients (HPAPIs) and sterile manufacturing requirements have created containment challenges for manufacturers. From ensuring operator safety, to protecting drugs from cross contamination, the need for more innovative containment strategies was high on the agenda for 2018. Smart wireless monitoring technology has been introduced to improve confidence in containment solutions. This type of technology has made it possible to receive crucial equipment usage data quickly and remotely, and provides continuous audit trails, allowing maintenance and operating teams to make decisions on effective maintenance and proactively manage the health status of their containment equipment.
Daniel Tedham, managing director, Wasdell Manufacturing a division of the Wasdell Group
The pharmaceutical industry is no longer focused on mass production and a ‘one size fits all’ approach. The drug pipeline is now more heavily devoted to developing novel treatments for rare diseases and meeting the demand for personalised medicine. The pipeline for blockbusting treatments affecting high patient populations is not as prominent as it was 20 years ago, with the focus instead moving towards smaller volume biotech products. Therefore, throughout 2019 I would expect to see further breakthroughs for rarer conditions.
Anita Paz, innovation consultant, Tjoapack
In recent years, the pharmaceutical industry has started to explore how improving the way they gather and analyse data could help to streamline the supply chain. And, with the advent of serialisation legislation and its associated data, there are even more opportunities for companies to access legacy information and gain more insight into operational performance. As we move forward, we will see more and more supply chain partners adopt machine learning to optimise their operations. This will be the case particularly for manufacturing and packaging service providers, for whom digital production registration and in-process control can improve operations at an organisational level and ensure smart quality control at line level.
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