15 January 2009
The pharmaceutical industry is seeing more of a shift to biological products which by their nature require aseptic filling; Brian Dougherty, chairman of SCM Pharma Ltd, examines the changing nature of the industry and the challenges that this poses for the future.
The global industry
According to research conducted within the global pharmaceutical industry, the development of a drug requires an investment of $1billion and a development period of 10-15 years. The same statistics also highlight that 80-85 per cent of these drugs fail at human trials stage, wasting billions of dollars and man-hours each year.
As a result, a monopoly has been created with only the larger industrial houses having the available resource and funding to bring drugs to market.
Over the past 5 – 10 years, there has been significant growth in the development of biological molecules for human medicinal use. As traditional small molecule ‘blockbuster’ drugs are becoming harder to identify and scientists’ understanding of how drugs work at a molecular level within the body, has increased, drug manufacturers have recognised the importance of offering aseptic filling using isolator technology, for both quality and economical purposes.
The positives
The use of sealed gas isolators provide the highest form of protection for aseptic products and also has shown to provide a higher level of sterility assurance than traditional aseptic process filling. This is because human borne contamination is eliminated within the isolator; in addition, reproducible biological decontamination to all of the exposed surfaces inside the isolator can be delivered.
From the outset, the introductory costs of implementing a biological isolation system are very high, when considering buying the equipment and training staff, particularly when compared with the traditional filling line cleanroom costs. Over the longer term, however, due to increased sterility, less risk of contamination and the associated reduced product waste, the overall drug development costs can be considerably reduced.
Historically, product recall because of sterility issues was commonplace in the pharmaceutical industry and as such costs were budgeted to allow for it. Thanks to this shift to filling using isolator technology, we are now seeing these contingency budgets considerably reduced which could mean bolstered profits for the few companies that get their drugs though to commercial manufacture.
Within the global industry there is talk about the benefits of the isolator technology and generally the consensus is positive, with the overall feeling that it is expensive to implement, but quickly pays for itself.
From a regulatory perspective, although there are no specific guidelines around its use, the US FDA (Food and Drink Administration) has publicly frowned upon larger US-companies that are yet to implement the use of isolator technology and to date, a number of them have received warning letters from the FDA prompting them to make the transition. In Europe, the response from industry bodies has not been so public, yet there is global appreciation that European companies have been quicker to implement the technology and as a result, are already enjoying the benefits.
Although safety is always top of the priorities agenda for any pharma company, from a safety angle, the use of isolator technology has also been highlighted as more stringent at safeguarding persons from the exposure of potent and potentially harmful new products in pharmaceutical development.
The negatives
Industry statistics highlight that the adoption of aseptic processing using isolator technology has been slow due to a number of concerns.
Firstly, the lack of regulatory support or advice and process validations has led some to believe that they should wait for the announcement of industry guidelines before changing their manufacturing processes. It is clear to see why some prefer to work ‘by the book’; as by its very nature, the pharmaceutical industry takes a clinical approach, in both senses of the word, so to minimise the threat of reprisal.
Secondly, cost has been cited as a problem for a number of companies that would find the immediate financial outlay of training staff and buying the technology, a serious constraint. My advice to those companies, which I imagine are small to medium sized, would be to seek an independent partner, within the UK, that already offers this service, at a reasonable cost.
Conclusion
In conclusion, it is obvious that the industry trend of implementing isolator techniques for aseptic filling is by the far the safest and best value for money. However, the lack of regulatory guidelines surrounding its use is still dissuading some from it, while others perhaps feel it to be too much of a financial outlay when they are yet to see the results.
In the short term, I feel companies that are still yet to ‘make the move’ may find their current processes are no longer cGMP-compliant because they cannot offer the level of product safety and security that only isolators can provide.
Lastly, in an industry like pharmaceuticals, where so much money and expertise is ploughed into drug development, with so few drugs actually making it through to commercial manufacture, I feel that technologies that can reduce some of this spending and time, without affecting the overall performance of the drug, should be embraced and supported.
About Brian Dougherty (MRPharmS QP), Co-owner and Director, SCM Pharma
With more than 30 year’s experience in quality assurance, manufacturing and research & development, Brian has a breadth of experience across the pharmaceutical sector. A registered pharmacist, achieving QP status in 1983, Brian set up SCM Pharma Ltd with Fiona Cruickshank.
Brian is a major ambassador for promoting careers in the pharmaceutical industry. He is Chair of the Association of Commercial Specials Manufacturers (ACSM), a member of the Chartered Institute of Directors and an elected member of the Industrial Pharmacist Group (of the Royal Pharmaceutical Society).
The global industry
According to research conducted within the global pharmaceutical industry, the development of a drug requires an investment of $1billion and a development period of 10-15 years. The same statistics also highlight that 80-85 per cent of these drugs fail at human trials stage, wasting billions of dollars and man-hours each year.
As a result, a monopoly has been created with only the larger industrial houses having the available resource and funding to bring drugs to market.
Over the past 5 – 10 years, there has been significant growth in the development of biological molecules for human medicinal use. As traditional small molecule ‘blockbuster’ drugs are becoming harder to identify and scientists’ understanding of how drugs work at a molecular level within the body, has increased, drug manufacturers have recognised the importance of offering aseptic filling using isolator technology, for both quality and economical purposes.
The positives
The use of sealed gas isolators provide the highest form of protection for aseptic products and also has shown to provide a higher level of sterility assurance than traditional aseptic process filling. This is because human borne contamination is eliminated within the isolator; in addition, reproducible biological decontamination to all of the exposed surfaces inside the isolator can be delivered.
From the outset, the introductory costs of implementing a biological isolation system are very high, when considering buying the equipment and training staff, particularly when compared with the traditional filling line cleanroom costs. Over the longer term, however, due to increased sterility, less risk of contamination and the associated reduced product waste, the overall drug development costs can be considerably reduced.
Historically, product recall because of sterility issues was commonplace in the pharmaceutical industry and as such costs were budgeted to allow for it. Thanks to this shift to filling using isolator technology, we are now seeing these contingency budgets considerably reduced which could mean bolstered profits for the few companies that get their drugs though to commercial manufacture.
Within the global industry there is talk about the benefits of the isolator technology and generally the consensus is positive, with the overall feeling that it is expensive to implement, but quickly pays for itself.
From a regulatory perspective, although there are no specific guidelines around its use, the US FDA (Food and Drink Administration) has publicly frowned upon larger US-companies that are yet to implement the use of isolator technology and to date, a number of them have received warning letters from the FDA prompting them to make the transition. In Europe, the response from industry bodies has not been so public, yet there is global appreciation that European companies have been quicker to implement the technology and as a result, are already enjoying the benefits.
Although safety is always top of the priorities agenda for any pharma company, from a safety angle, the use of isolator technology has also been highlighted as more stringent at safeguarding persons from the exposure of potent and potentially harmful new products in pharmaceutical development.
The negatives
Industry statistics highlight that the adoption of aseptic processing using isolator technology has been slow due to a number of concerns.
Firstly, the lack of regulatory support or advice and process validations has led some to believe that they should wait for the announcement of industry guidelines before changing their manufacturing processes. It is clear to see why some prefer to work ‘by the book’; as by its very nature, the pharmaceutical industry takes a clinical approach, in both senses of the word, so to minimise the threat of reprisal.
Secondly, cost has been cited as a problem for a number of companies that would find the immediate financial outlay of training staff and buying the technology, a serious constraint. My advice to those companies, which I imagine are small to medium sized, would be to seek an independent partner, within the UK, that already offers this service, at a reasonable cost.
Conclusion
In conclusion, it is obvious that the industry trend of implementing isolator techniques for aseptic filling is by the far the safest and best value for money. However, the lack of regulatory guidelines surrounding its use is still dissuading some from it, while others perhaps feel it to be too much of a financial outlay when they are yet to see the results.
In the short term, I feel companies that are still yet to ‘make the move’ may find their current processes are no longer cGMP-compliant because they cannot offer the level of product safety and security that only isolators can provide.
Lastly, in an industry like pharmaceuticals, where so much money and expertise is ploughed into drug development, with so few drugs actually making it through to commercial manufacture, I feel that technologies that can reduce some of this spending and time, without affecting the overall performance of the drug, should be embraced and supported.
About Brian Dougherty (MRPharmS QP), Co-owner and Director, SCM Pharma
With more than 30 year’s experience in quality assurance, manufacturing and research & development, Brian has a breadth of experience across the pharmaceutical sector. A registered pharmacist, achieving QP status in 1983, Brian set up SCM Pharma Ltd with Fiona Cruickshank.
Brian is a major ambassador for promoting careers in the pharmaceutical industry. He is Chair of the Association of Commercial Specials Manufacturers (ACSM), a member of the Chartered Institute of Directors and an elected member of the Industrial Pharmacist Group (of the Royal Pharmaceutical Society).
