Clinical manufacturing Facilities

Clinical manufacturing Facilities

Before I sat down to write this article, I considered the main factor influencing and affecting this industry today, and I concluded eventually that there is no single development or circumstance that stands out in particular. In fact, there are a whole range of factors that can make the difference between success and failure for an expanding small or medium clinical manufacturing company.

Growth

The first issue for any business is the process of growth and how it is managed. The market is out there, but it’s vital that a planned expansion strategy is put in place and then followed. Part of the reason for this is the standards, whether stipulated by a regulator or demanded by a client, which must be met and surpassed at all times. I believe that smaller operators must benchmark their facilities and quality control regimes against the large pharmaceutical manufacturers if they are to attract the clients and contracts that will help to achieve sustainable growth.

In essence, if we are to compete with our larger rivals, attract business from them or work in partnership with them, all of which will occur with increasing regularity over the next decade, we have a duty to attain and exceed the standards that they expect from their own facilities.

People

One of the greatest challenges facing our industry is people. Here in the UK, we have a great asset in the knowledge and enthusiasm of our workforce, but the lack of new graduates entering the industry is a tangible threat to our long-term prosperity, which we must work together pro-actively to address. Right down to school level, there is a need to advise, to engage and to enthuse.

Few businesses have a more exciting environment for young people to visit than a clinical manufacturing facility, something that is borne out by the number of production technicians, recruited and trained by SCM Pharma, who initially came to us on school visits. Further up the chain, we must work with colleges and universities to ensure that the correct training courses are in place, to ensure that they are aware of our existence and, where necessary, to offer our own skills and resources.

Once knowledge has been lost, it cannot be regained, which is why we encourage our own team here at SCM Pharma to engage pro-actively whenever training opportunities arise. For example, our own pharmacists are guest lecturers on the BTec course at Tyne Metropolitan College, which we also use to train our production operatives. We also provide lab resources, arrange site visits for all of the students and provide an annual student prize, together representing a tangible long-term commitment to the college and the course.
Sterile Product Manufacturing

The arena of sterile product manufacturing presents training challenges all of its own. More than any other area, this sector is suffering from the loss of employment opportunities and trained experts, a trend represented by the gradual drift to Eastern Europe and ongoing lay-offs by larger companies such as AstraZeneca. This is all the more unfortunate because it’s an area in which the UK truly excels and the mantle of excellence is now being passed to companies in the SME sector.

Companies like ours can, of course, benefit from the trickle-down effect as skilled individuals seek alternative employment, but the long-term threat is that new entrants to the industry will see no opportunities in the sterile sector as a specialism and vital skills will ultimately be lost.

Economy

The current decline in the global economy presents no direct threat to clinical manufacturing as funding for drug trials and development is still coming through. It is a given that our industry will always need to innovate in order to survive and, at the present time, most of the services and skills available in the UK cannot be sourced more cheaply elsewhere.

One consequence of changing economic circumstances will be a change in the way that companies in the sector interact. It seems that the mega-mergers of the past decade are giving way to a renewed focus on partnerships, joint ventures and marketing alliances which have the potential to make us stronger together.

Earlier this year, SCM Pharma announced a strategic alliance with Penn Pharmaceuticals, which will see the two companies work together to provide outsourced services in sterile manufacturing, packing and distribution of investigational medicinal products (IMPs) for the UK and international markets. This will enable both companies to offer an extended range of products and services under their individual brands, while also opening up Penn’s established international sales network to our own expertise and product range.

Another opportunity for SMEs in the clinical manufacturing sector will be a transformation of volumes. As drugs and their delivery systems become increasingly bespoke in the drive towards personalised medicines, the capacity to manufacture relatively small batches will become an advantage. Demand for bespoke products is certain to grow and co-operation between smaller manufacturers will become even more important as larger companies, hospitals and health trusts look to source the maximum number of items from the minimum number of suppliers.
Solid Dose Injection Technology

Regulation

Within the current trends influencing our industry, it is an irony that increased regulation can actually become an opportunity. I’ve already touched upon the need to for high quality manufacturing facilities, but we can also capitalise on developments such as the new European regulations, which stipulate that all new drugs must have protocols to demonstrate that they can be effective in the treatment of children. This is a major undertaking that will require a large number of relatively small-scale trials, something which our industry can undertake far more cost-effectively than a large-scale manufacturer.

The major growth areas for our industry will be development and production and we stand to benefit as drug trials and testing become more commonplace and more complex. There will always be a need to test medicines on humans and the skills and technology needed to ensure that these trials are conducted to the highest standard is an area in which the UK excels. From manufacture to drug packaging, labelling and distribution, we can continue to set the standard for consistent quality and excellence.

SCM Pharma is currently working with a company called Glide Pharma on its patented needle-free, solid dose injection technology – the Glide SDI™. We have been looking at the process development and validation for the drug product which will eventually be adapted to a huge range of injectable products, encompassing small molecules and biologicals, including vaccines. The expertise involved in the design of this product was huge, but a whole different set of skills was required for the later stages of development.

The pharmaceutical industry has become an increasingly global entity over recent decades as drug development costs have soared and international travel has caused specific illnesses to become more widespread. The opening up of foreign markets for smaller operators is a relatively recent phenomenon, however, and only in recent years have we begun to identify the opportunities available in the European Union, the United States and beyond.

In a sector where each company has its own specialist area of expertise, there will always be opportunities for businesses to work together as SCM Pharma is working with Penn. If you have a product or service that another company needs, and they have something that your own company can benefit from, such as an international sales network, the logic for collaboration is almost overwhelming