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John Ruesch is the associate director in QC/Stability/Compliance in the Analytical Research and Development of Pfizer Global Biologics
Amy St. Charles is a senior scientist in QC/Stability/Compliance in the Analytical Research and Development of Pfizer Global Biologics
By following key strategies, companies can reduce the risk and increase the benefits of outsourcing analytical development and testing
In the past five years, analytical testing performed at contract laboratories has increased significantly in the pharmaceutical sector. As biopharmaceutical companies seek to reduce cost, optimize speed, and increase the flexibility of their research and development, this trend will only continue. Pfizer Global Biologics has been using contract organizations for analytical testing for the past five years. This strategy has proven critical in meeting our portfolio demands and has allowed an increase in the total number of drug development projects we manage at any one time.
This article discusses the risks and pitfalls associated with outsourcing analytical testing and effective strategies to circumvent or mitigate these risks and pitfalls. In this article, we will be using the term sponsor to refer to the group outsourcing the work.
Analytical outsourcing must be approached in a systematic manner to ensure that the sponsor receives the greatest possible return on investment as it pertains to time, effort, and overall cost. When choosing a contract analytical laboratory, therefore, the sponsor must keep a series of questions in mind, such as:
There may be additional questions applicable to certain projects, but these questions provide insight into variables that affect outsourcing efficiency with respect to time and money spent.
After the decision has been made to enter into a partnership, the following are some of the possible risks associated with working with a contract analytical laboratory. Through proper mitigation strategies and contingencies, the sponsor will be able to manage these risks. These strategies are also discussed below.
Risk: Contract research laboratories often have a high rate of turnover.
Contract laboratories are very attractive for new bachelor-level college graduates. The contract laboratory provides an excellent opportunity to gain practical, hands-on experience that will allow the laboratory analyst to pursue other options.
The turnover rate is proportional to the demand and density of the contract analytical laboratories in that particular geographic location. For example, the east and west coasts seem to have the greatest turnover rates, whereas certain locations in the mid-west have less employee turnover.
Recommendation: When selecting a contract analytical laboratory, the sponsor should obtain information about the employee turnover rate. The key analysis compares the laboratory analyst turnover rate and the managerial turnover rate. By evaluating these metrics, the sponsor can gain valuable insight into the contract analytical laboratory's philosophy regarding retention.
Risk: Infrastructure at the contract analytical laboratory may not grow proportionally to meet increased demands or workload.
As with all businesses, the key objective for a contract analytical laboratory is to meet customers' expectations while making a profit and meeting its fiscal responsibility to shareholders. Sometimes, because of pressures to hold down costs, contract analytical laboratories do not hire enough support staff to keep up with increasing workloads.
Recommendation: In our experience, it is very important that the sponsor monitor and work closely with the contract laboratory to ensure that the infrastructure positions (quality, metrology, maintenance, supervisory, and administrative) grow as demand for services increases. The sponsor must have consistent interactions with all aspects of the contract analytical laboratory organization—management, business development, quality, and laboratory. It is important to set up regular meetings with all levels, at least quarterly.
Risk: Having too many people involved in the day-to-day communications creates confusion.
Although constant communication is one of the most important best practices to follow when using a contract laboratory for analytical testing, it is also important to limit the number of people involved in the day-to-day discussions that take place between the sponsor and the contract analytical laboratory.
Recommendation: Two main points of contact should be established at each site: one person to work on the business aspects of the relationship and one point person to handle technical and scientific issues. By having these main points of accountability, both the contract analytical laboratory and the sponsor can avoid confusion about what information has been disseminated and to whom. The sponsor also can ensure that the correct questions are being asked, the right answers are being provided, and the appropriate people are involved in the exchanges. For example, if there is a change to an analytical method that has been transferred to the contract laboratory, the single point of accountability from the sponsor's organization and contract laboratory will effectively disseminate this information, thus ensuring consistent information exchange.
It is still important to have communication and interactions with all aspects of the contract analytical laboratory's organization, but such meetings can be set up at regular intervals, whereas day-to-day communications are handled by the two point people mentioned above.
Choosing the people to be the single points of accountability in each area is also key to a successful relationship between the sponsor and the contract analytical laboratory. The sponsor should ensure that the people chosen have the proper knowledge and tools to be successful in their roles.
Risk: Regulatory actions are taken against the contract laboratory.
Recommendation: The sponsor should research the history and past performance of a contract analytical laboratory to ensure that the contract analytical laboratory meets all regulatory requirements and has established quality systems in place. It is also critical that the sponsor understand the dynamics and deliverables of the contract laboratory's quality system to ensure that it will mesh with the sponsor's quality system.
Then, after a relationship with a contract analytical laboratory has been established, diligence should not waiver. It is imperative that the sponsor continue to monitor the level of quality at the contract laboratory with audits, regular communications, meetings, and updates on testing. The business contract and the quality agreement are critical in establishing the framework and understanding what each party is responsible for. These two documents are the foundation of the relationship that will go a long way toward establishing a strong compliant relationship.
In addition, the sponsor should also be using more than one contract analytical laboratory for testing. This way, if a problem is detected at one contract analytical laboratory site, testing can be pulled quickly and sent to other established contract site with minimal disturbance to the timeline for the compound being outsourced.
Risk: The contract laboratory does not fully understand the technology used in methods transferred, including method nuances.
Recommendation: From our experiences with analytical method transfers, both internal and external, one of the key factors in a successful transfer is ensuring that the receiving analytical laboratory has a full technical understanding of the methods being transferred, as well as any nuances the methods might have.
Taking the time, up front, to ensure that this understanding exists, can save countless hours of troubleshooting by the sponsor during and after the analytical method transfers. This can be accomplished by performing face-to-face training with the contract analytical laboratory (analysts from the sponsor can travel to the contract analytical laboratory, or vice versa). It cannot be stressed enough that this is a critical aspect in the relationship or partnership with the contract laboratory.
Risk: The method transfer exercise does not adequately test the contract laboratory's capabilities.
To truly have a successful analytical method transfer, the sponsor must have complete confidence in results generated by the contract analytical laboratory (see sidebar).
Best Practices for a Successful Analytical Transfer to a Contract Analytical Laboratory
Recommendation: To accomplish this, we believe that a key factor is the design of the method transfer, or more specifically, the choice of the sample set to be used in the analytical method transfer exercise. Often, to save time or for the ease of the sponsor laboratory, analysts at the sponsor site and the contract analytical laboratory perform comparability testing on samples that have already been tested for release at the sponsor site. Although this is acceptable for part of the sample set, it is also important to use spiked or degraded samples in the comparability testing. By using samples that generate results that are out of the ordinary, the sponsor will better demonstrate that the contract analytical laboratory can obtain results equivalent to those obtained in the sponsor's own laboratories.
A key similarity among all of the recommendations given in the above examples is the necessity of constant communication. Communication is key to ensuring that analytical testing performed by a contract analytical laboratory is successful, from both a business and a scientific perspective. Current market trends in the pharmaceutical industry indicate that the use of contract analytical laboratories will only continue to grow, both domestically and internationally, in the coming years. Using the best practices and recommended strategies highlighted here can help sponsors to avoid pitfalls and mitigate the risks associated with the outsourcing of analytical testing.
John Ruesch is the associate director, and Amy St. Charles is a senior scientist, both in QC/Stability/Compliance in the Analytical Research and Development of Pfizer Global Biologics, St. Louis, MO, 636.247.5146, firstname.lastname@example.org