Director of global managed services at Zenith Technologies, David Staunton, speaks about innovations, trends and challenges affecting the industry in 2017.
2017
1. In your opinion, what has been the most important innovation for the year?
I believe that the most important innovation in the pharma sector relates to the change in the scale and mobility of manufacturing equipment. Across all the sectors in life science, the scale of the equipment is changing. For example, in the biotech sector it is changing in both directions at the same time, both big and small.
Large scale drug substance (DS) plants are getting even larger in response to the very real promise of mAbs[1] products that are effective for large portions of the population. mAbs projects are driving a significant increase in large scale DS facilities across the world. Often these facilities have four or more 10,000 litre bioreactors at the heart of their upstream process.
At the same time, an improvement in technology for single-use and mobile equipment is driving a reduction in the size of some DS facilities. Biotech clients are now able to produce multi-product, flexible facilities on a smaller scale providing much faster delivery for new smaller volume products.
This reduction in scale also applies to both the biotech and pharma chemical facilities with the introduction of continuous manufacturing. New processing techniques and real-time data analysis methods are allowing a portion of the GMP manufacturing process to be continuous rather than batch. This reduces the size of the facility while at the same time increasing flexibility. These changes in scale all bring new challenges for the industry because there is an increased focus on standard software design in combination with a focus on standard equipment design.
The standardisation is being driven by a necessary separation of the equipment lifecycle from the software lifecycle. Although it may not be intuitive at first, to increase flexibility, you must first standardise. Flexibility requires standard software and equipment design that can be put together in a modular way. It’s the modularity that gives the flexibility. Its equivalent to creating building blocks like children’s Lego except with very sophisticated equipment and software that act as the parts that click together. This standardisation is driving an increase in the life and flexibility of the stainless steel equipment and a much shorter life in the mobile equipment to the point that some of the equipment is genuinely becoming single-use. It is also driving standardisation of the software to allow the inter-changeability of the equipment.
One side effect of this standardisation is that it has increased the focus on data collection and analysis.
2. What has been the biggest opportunity of 2017 for your company/ organisation?
The pharma industry is at an exciting inflection point, with project delivery focused on driving more effective approaches in three core areas. These are; improving the integration between automation, MES and data collection systems, a move away from paper based records to Electronic Batch Records (eBR) and the use of mobile and single use equipment.
This evolving industry focus, combined with the large scale capital investments, is allowing our clients to ‘make the most of now’ both this year and into 2018. For the life science manufacturing industry, it’s not about being new – it’s about using proven solutions and approaches to decision making to improve quality, reliability and reducing waste.
Back in April, GE Healthcare also invested in Zenith to deliver the next generation of biopharma automation. This enhancement and partnering brings about increased automation capabilities that directly supports the movement of our diverse customer base and the next generation of manufacturing solutions.
3. What market trends have been influential for 2017?
The enormity of serialisation projects have driven a trend towards outsourcing project implementation to specialist third-party suppliers.
As the deadlines for EU and US regulatory enforcement approach, the need to become compliant is becoming more urgent. Research shows that 36% of life science companies believe they have a knowledge gap in their existing teams when it comes to serialisation[2]. This gap has created a trend in alliance partnering for serialisation, where a third party vendor is an integral part of the philosophy, design implementation and support of serialisation systems.
This has been an area of growth for Zenith in 2017 and it fits very well with our overall service philosophy in which we partner with life science companies as an integrated extension of their teams.
4. What have been the biggest challenges of the year?
Certainly, for some of our clients the compliance with the new serialisation regulations in the EU and the US represent a significant challenge and continues to call for substantial investment. Zenith, in conjunction with serialisation software provider SEA Vision, undertook an industry-wide survey3 and found that more than half (54 %) of professionals in the sector believe that the cost of implementing serialisation is the greatest hurdle to compliance. A further 33 % of respondents stated the implementation process would be a drain on internal resources, and 31 % cited tight timescales as a pain point, a statistic that is further supported by the FDA’s decision to delay the active enforcement of the Drug Supply Chain and Security Act (DSCSA) due to a lack of readiness across the industry.
For some of our other clients, resourcing the start-up of their facilities at the right level with the right expertise is a current pain point. Capital investment tends to come in waves, as confidence grows and industry wide innovations are realised and the life science industry is no different. Therefore, a lot of projects are happening in parallel and the demand for Engineers has never been higher in our industry.
[1]Monoclonal Antibodies (mAbs) specifically bind to a target cell providing potentially very effective treatments, therapy and detection for disease.
[2] http://www.zenithtechnologies.com/zen-blog/cost- serialization-compliance