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Pharmaceutical Manufacturing and Packing Sourcer

Take Control

The UK pharma and life sciences sector is facing many challenges that will influence the prospects for all companies, be they Big Pharma, generics or contract manufacturing operations. Basic pharma product manufacturing – which includes medicinal active substances, antibiotics, basic vitamins and pure sugars – is predicted to show growth of -0.7 per cent over the next five years. This contrasts with the healthier prospects displayed by pharma preparation manufacture, including biopharma – which expects to see growth of 2.9 per cent over the same period.

Pressure to Succeed

Market pressures – ranging from regulatory controls, global manufacturing competition, product diversification, demographic changes and economic issues – are forcing a re-assessment of how manufacturing and production solutions can help meet such demanding market drivers. One only has to acknowledge the upsurge in merger and acquisition activity in the sector to realise that many are, for example, addressing the shortage of new therapies by bolstering their existing product portfolios from elsewhere.

This creates additional technology challenges as operations directors and heads of engineering suddenly find they are overseeing multiple technology standards across the enterprise of the business, and must deal with a new and complex technology platform with wideranging legacy technology standards currently running their operations. A good example is the difficulty in correlating disparate data management systems across operational sites as organisations come together.

Such pressures apply equally to major pharma manufacturers as to the rapidly growing businesses reliant upon providing generic products at extremely competitive prices. Here, any undue costs because of product waste issues, energy consumption or production downtime can severely influence the bottom line. Indeed, in this arena, lost production through downtime has been known to culminate in entire order cancellations – market competition is growing and delivery guarantees can always be made elsewhere.

New Business Model

The major pharma business model is being re-assessed within a new commercial and operational reality – one that is increasingly putting manufacturing operating efficiencies at the core of future strategies. This is driven in part by the looming void created by a lack of new blockbuster drugs in the development pipeline, as well as the influence of generic production – which has rapidly entered the market as star drugs come off-patent.

The slowdown in output has coincided with top-selling drugs losing patent protection and falling prey to competition from cheaper versions. Together with many governments around the globe, UK political leaders, via the National Health Service (NHS), are demanding price cuts for the vast amount of drugs they purchase – and the pharma sector and all its constituents must seek answers to offset a future where tight margins are the new norm and intense competition is rife.

Operational Drivers

Three primary operational drivers are currently influencing the sector: the need to reduce manufacturing costs; the ongoing responsibility to maintain product quality; and the regulatory requirement to ensure patient safety at all times.

These are significant challenges, but they are key areas of operation which, if the examples of the automotive and electronics sectors are followed, can benefit from advanced automation technology to deliver real value to a business. The sectors cited have, through their respective adoption of Lean manufacturing techniques and advanced technologies, witnessed massive advancements in the operational efficiencies of their processes over recent years and are exemplary models of best practice. Pharma and life sciences organisations need to follow suit. The time for talking is over.

While there is a growing interest across the industry in tackling the ‘inefficiency’ of manufacturing operations, it is still largely behind the technology curve – particularly in the automation arena. It is restricted in many cases by an ‘adverse to change’ culture, incumbent and often obsolete legacy production systems, and a situation exasperated by the heavily regulated nature of the business and its procedures to protect patient safety.

How Technologies Can Help

Collaboration with trusted, experienced and knowledgeable technology partners can lay a solid foundation. For example, the ability to continually develop technology products and solutions to address changing manufacturing demands, support sustainable operations and ensure patient safety, offers the market a technology pathway to drive asset value and reduce time to manufacture.

The delivery of real-time, accurate date measurement tools also ensures product quality within a validated manufacturing process. As such, commercial pressures to optimise and safeguard production can be satisfied, while access to intelligent and quick data generation not only provides compliance assurance, but can also inform and drive management and production strategies, as well as future direction.

Key technologies underscore the objectives around reducing costs, driving quality and keeping patients safe. The integration of real-time data management; techniques such as Process Analytical Technology and Quality by Design; unique product identification concepts – serialisation and ePedigree tools, for example – to combat the growth of the counterfeit market; electronic batch recording; and weighing and dispensing solutions, can only enhance and optimise manufacturing performance – as well as protect the corporate brand.

Lifecycle Support

However, the integration of such technologies only tells part of the story. The true benefit comes from a holistic approach that understands how technologies and data management can support a better understanding of the process and operation – from starting materials through to the pharmacy – as well as aid ongoing manufacturing process efficiency.

Central to this is the lifecycle support model that has been adopted by many other industrial sectors, which has protected and maximised investments, and helped drive continuous assessment of the changing demands companies can face. With technology at its centre, lifecycle support ensures a sustainable future by managing obsolescence, as technology solutions improve and a transparent life cost model is established.

Forward Thinking

The pharma and life sciences sector in the UK makes an important contribution to the economic health of the nation, and its scientific expertise is renowned around the world. But the commercial environment continues to evolve and change, and unfortunately it will be the inert manufacturing operations that are left behind.

Applicable and proven technologies to help drive reductions in cost of manufacture; optimise operational efficiencies; deliver the right product on time, every time; and maintain the trust of purchasing governments, health authorities and patients, are currently available. A reluctance to invest in such technologies, particularly when competitors are embracing them, means you are effectively standing still. That is not a viable option for a healthy commercial future.

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Alan Johnston is the Pharmaceutical and Life Sciences Business Manager for Siemens Industry, a leading global supplier of industrial plant and software, manufacturing automation and drive technologies to industrial customers across the UK. His career began as an Instrument Artificer Apprentice with Imperial Chemicals Industries, before moving into process automation projects and solution delivery within the chemical, oil and gas, and pharmaceutical industries, latterly supporting HQ on global projects and initiatives. Subsequent roles have taken Alan into sales, key account management and consultative positions. He holds Chartered Engineering status and is a member of the Institution of Engineering and Technology.
Alan Johnston
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