By Tim Roberts, Associate Director Clinical Services, Packaging Coordinators, Inc.
Summary
Analytical laboratories have a responsibility to successfully execute qualitative and quantitative analysis on potential drug discoveries. These testing labs have an important role in the clinical trial drug process, providing the pharmaceutical industry with the necessary data during the drug development process. However, over the past few years the industry has faced numerous challenges with off-site analytical laboratories; including, geographical and financial implications, time constraints and the use of unfamiliar in-house staff. The pharmaceutical industry now recognises the need to have on-site analytical laboratories to both monitor the process internally, whilst accelerating the process without affecting the quality or knowledge applied.
Introduction to Analytical Laboratories
Analytical laboratories, whether on-site or off-site, perform qualitative and quantitative analysis on sample testing and packaging each product. Undoubtedly, they will always play a vital role in the analysis, packaging, development and commercialisation of drugs. These laboratories provide the pharmaceutical market with a niche and technically specialist service that is integral in continuously aiding pharmaceutical manufacturers in their overall drug development process; offering continual testing support through the lifecycle. However, analytical laboratories are also required to meet high levels of governmental approvals and high levels of safety testing, which is the responsibility of the manufacturing company. As a result of this challenge, analytical laboratories face unnecessary financial and time pressures, creating a strong need for a solution that can eradicate all of the above issues immediately. To uphold the highest level of quality these laboratories require state of the art equipment that is close at hand, in addition to skilled employees to ensure maximum levels of communication and a wide time frame. Of concern, is that off-site analytical laboratories cannot ensure all of these elements are provided, and thus there is now a need for on-site laboratories, to ensure optimum performance without compromising on quality or knowledge.
Geographical Challenges with Off-site Analytical Laboratories
The process of testing and packaging is a vital part of producing a new pharmaceutical drug, yet it can be time consuming, geographically difficult and expensive for the company developing it. Analytical testing laboratories which are situated off-site, whether overseas or not, create a huge boundary that needs to be overcome to improve efficiency. Off-site analytical laboratories create large physical distances between the testing site and the key personnel who are providing direction to the laboratory’s facilities. As a result of these geographical difficulties, this process can take a total turnaround time of three to fourteen days depending on the sample.[1] This can prove very problematic if a company requires a project to be completed in half the time; a service for which the company would likely be charged twice the standard cost. With an off-site laboratory, the geographical implications can create a distant relationship between the pharmaceutical company and the testing company that can result in communication and project management challenges. Given the sensitive nature of these services in conjunction with the amount of pressure on the testing laboratories, the premise of being able to visit the facility in which the product is being processed quickly, not only instills confidence in the analytical laboratory and in their personal handling of the product, but it also permits the pharmaceutical company to personally oversee the process their product is going through.
Time Constraints with Off-site Analytical Laboratories
In connection with the geographical issues, off- site laboratories can also create time constraints. For example, when choosing a laboratory, a pharmaceutical company must dedicate time to research the laboratory provider and determine if they meet the necessary regulatory requirements, including their past success rate in a particular therapy sector. This process can be extremely resource-intensive, in terms of commitment, time and money. In addition to the above, further time restrictions occur while testing and commercialising a new medicine with the usual challenges repeatedly taking weeks to solve. Another example of time constraints with off-site analytical laboratories is global time differences. A query may occur but a response from the relevant team is not received until the next business day, leaving a time gap in which the issue could be resolved. This preventable delay in communication has an impact on the entire production process, ultimately potentially postponing the final release date.
Financial implications with Off-site Analytical Laboratories
With the charges of product transportation and delivery continuously rising, in addition to the often slow nature of the entire testing and packaging procedure, the act of transferring drug samples seems like an unnecessary expenditure in the release process. For example, the American Department of Transportation’s decision to ban the air transportation of concentrated nitric acid[2] has presented the pharmaceutical companies with evidence of the current declining state of scientific shipping. The FDA regulations mean that even more hurdles need to be overcome with strict regulations, not only on the actual shipping of medicines but also issues such as product storage and labelling requirements. This means that there are further resource requirements, in addition to the overall priority of delivering a consistently high quality product. The additional costs of the courier and recorded delivery to ensure the products’ safety when shipping, is both an unnecessary cost and one that can be easily avoided with an on-site analytical laboratory.
Consequences of Independent laboratories using private technicians
It is now common for independent organisations to use their own members of staff to process a pharmaceutical company’s product. The concern with companies using their own staff in laboratories is that the staff handling the product will not have been selected by the manufacturer and will have no direct contact or communication with them. As a result, this can create complications for the drug company in regards to trust issues, quality assurance, monitoring, control and consistency. A further concern for pharmaceutical companies is that off-site laboratories will provide independent results meaning there is no way to be sure of the accuracy or validly of data. The presentation of such results can differ to the requirements of each individual manufacturer, an additional requirement to be agreed at the start of the project.
The need for on-site Laboratories
Many of the challenges mentioned above can be resolved with the introduction of on-site analytical laboratories. One of the main benefits of having analytical laboratories on-site means that they can be tailor-made to each company’s individual requirements, and needs; right from layout, design and equipment through to the staff hired to work in the laboratory. This allows a manufacturer closer, direct access and insight into the entire process and the results, something many manufactures insist on. Another benefit of on-site laboratories is that turnaround times are greatly reduced as there is no longer a need for transportation. Any problems that arise can often be resolved quickly and efficiently, typically in a matter of hours, rather than days. Similarly, the ability to make adaptations becomes much easier and cheaper than before.
The speed with which results are processed and generated can be significantly improved by having an on-site analytical laboratory. The primary advantage is that the investigators can react to data in real time, as it is generated. If a problem arises, it can be identified, adjusted and rectified accordingly, all in a matter of hours. This removes the expensive requirement for multiple returns to different sites, cancelling out the need to undertake further investigations to complete the original analysis. The rapid production of results improves efficiency and productivity of the drug development process.
There are clear financial benefits from investing in an on-site analytical laboratory, with the high costs typically associated with off-site test laboratories now removed. The elimination of shipping and safety checks saves companies considerable costs for every sample that would have required testing. The financial saving can also be linked to the improved staffing quality, as a pharmaceutical company can now select the key personnel who work on the project which, in turn, can guarantee a higher level of trust, security and overall quality of performance.
Furthermore, situating an analytical laboratory on-site means the geographical implications are also limited. Individual companies can meet the staff testing their product personally, meaning they can discuss the process in detail, on a daily basis, rather than having to wait to be updated on the process. This aids the pharmaceutical company by offering the business full transparency into the status of the project, instilling confidence in the laboratory’s abilities. Additionally, there are no time difference issues to consider because everything takes place in the same location and under one roof, increasing productivity and efficiency.
With the safety of the product being of utmost importance for the analytical laboratories, a company’s ability to oversee the development of the treatment and therefore evaluate the quality of work is vital. Having an on-site laboratory generates a stronger sense of supervision over the process, meaning that companies remain confident and conform throughout the entire development.
Finally, the building of an on-site testing laboratory minimises the risk of information loss or miscommunicated between the pharmaceutical company and the testing site. With the high importance of clinical trial data to any pharmaceutical company’s future product success, the guarantees of an in-house activity system can rarely be matched.
Looking into the future
Anticipating future activities, opportunities and legal obligations of the pharmaceutical industry is challenging; but the need for a core laboratory, where all stages of the analysis process is under one roof is most definitely required for future processes.
With the pharmaceutical industry continuously growing, the market is constantly looking for ways to expand, managing time-to-market, reducing costs and meeting the ever increasing regulatory frameworks. There is now a very clear argument for the investment in on-site analytical laboratories, and one that is highly encouraged for improved productivity and efficiency. These on-site laboratories provide critical operational and environmental data and establish the value of the product, all of which are crucial, meaning on-site laboratories have a place within the market. They provide the ultimate collaboration between dedicated equipment and flexibility to conduct new activities, supporting both the quality and growth that future laboratories require.
Ultimately, building an analytical laboratory on-site has many benefits as explored earlier on in the text, but the ability for a company to have a site that exactly meets its requirements and control the entire process is revolutionary in the pharmaceutical industry.
References
For more information on PCI and its services, please email [email protected], call +44 (0) 1497 820 829 or visit http://bit.ly/PCI_Services.
About Packaging Coordinators, Inc.
Packaging Coordinators, Inc. (PCI) specializes in providing packaging solutions to the global healthcare industries that need to increase their products’ speed to market for commercial success. PCI brings the proven experience that comes with over 50 successful product launches a year and more than 40 years in the healthcare business. Continued investment and leading technology allows PCI to meet global packaging needs throughout the product life cycle - from Phase I clinical trials through commercialization and ongoing supply. PCI’s clients view the company as an extension of their business and a collaborative partner, with the common goal of improving patients’ lives.
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