Sample preparation and processing are often crucial components in immuno-oncology and cell and gene therapy studies. Obtaining timely and high-quality processing services is an industrywide challenge, particularly within the context of global trials.
Global points of service, standardized processes and materials, control of sample logistics, and performance monitoring can mitigate concerns over long-distance shipments, variable transport conditions, and the quality and consistency of laboratory techniques and biostorage.
Here we consider three of the keys to success for global sample processing: specimen collection and transport, consistency in analytical technique, and biostorage. For every sample’s integrity to be upheld throughout its life cycle, the chosen laboratory must be able to meet these criteria reliably.
1. PROPER SAMPLE COLLECTION AND TRANSPORT
Ensuring that samples are collected properly and shipped to and from processing labs quickly and traceably, while maintaining sample viability, is a fundamental requirement for successful sample processing.
The first challenge in ensuring sample quality and maintaining integrity occurs at the sample collection site. Pre-analytical variation is the leading cause of laboratory error. Without a properly collected sample, the chances of a successful isolation are significantly diminished. Collection supplies should be well organized and packaged in a way that allows the site to reliably collect and package the sample for shipping. Collection site staff training is key. Training materials should be clear and highly specific to each step in the collection and transport process. In global trials, translation services may be of benefit.
Shipping materials are another critical component of the supplies sites need. Whether provided by a central lab or a logistics partner, care must be taken to ensure that the shippers are properly validated for the required transport temperature range. Previewing the validation documentation can confirm that the proper steps have been followed. Every opportunity to improve sample quality should be utilized.
For example, advanced virtual accessioning tools such as digital pens can be used to record demographic and sample collection information in real time.
A primary determinant of turnaround time is the distance to the lab. Shipping samples inherently takes time, but international shipping is particularly challenging. Unexpected infrastructure failures and delays in customs processing can take precious hours from available specimen stability time. To lessen this risk, partnering with a central lab organization with access to regionally based laboratories significantly minimizes shipping distances and duration — thereby optimizing viability of time-sensitive samples.
Real-time sample tracking provides efficiencies — and peace of mind. Tracking the movement of samples from accession to receipt at any lab or storage facility in the world is critical to the sponsor’s peace of mind and increases the processing lab’s ability to prepare for incoming materials. Enhanced security and integrity of samples, increased control over shipping logistics and costs, easy report generation, easy retrieval, and a chain-of-custody trail may all be benefits of real-time sample tracking systems.
The right logistics partner will preserve sample integrity and minimize delays. Appropriate sample management in regulated bioanalysis is crucial: If samples are compromised at any stage prior to analysis, study results may be affected. There are vast differences in capabilities, equipment, experience, resources, global reach, and regional experience amongst logistics companies. Sensitive sample types need reliable solutions. Can the carrier offer temperature-controlled specimen transport? Does the company know the local geography and politics well enough to efficiently retrieve samples from rural areas — and negotiate customs without difficulty? Dry runs to verify claimed shipping lane delivery times can be a good investment.
2. PROVIDE ACCESS TO A GLOBAL NETWORK OF LABS VETTED FOR HIGH-QUALITY PROCESSING
Laboratory proficiency is essential for successful sample processing and preparation. Identifying and qualifying labs across the globe requires time, experience, and diligence — and can’t be left to chance. The chosen lab partner should ensure that the labs it operates and/or subcontracts with can all produce comparable, quality results.
- Labs that can help meet expedited demands must be identified and pre-selected, worldwide. A high-performing central lab should be capable of targeting and evaluating current and potential partner labs across the globe to determine whether their facilities, training, and experience meet required quality standards. Qualified labs can then be used strategically to meet expedited demands, as necessary.
- Standardized analyst certifications can help ensure that participating labs maintain suitability despite staffing turnover. Upholding standards over time requires vigilance — the kind of vigilance a highly experienced global central lab with a large, closely monitored network is best positioned to deliver. Networkwide sample processing proficiency programs can help ensure that all participating labs qualify their staff in a standardized and sustained manner.
- Centralized performance monitoring ensures worldwide quality. Monitoring sample preparation results such as PBMC recovery and viability or DNA/RNA concentration and purity is a systematic way to ensure ongoing, high-quality performance and successful downstream testing when these samples are used.
- Centralized monitoring of results; centralized performance monitoring of global data by qualified scientific personnel enables troubleshooting to occur in near-real time, reducing the costs associated with poor performance at either the site or performing laboratory level.
3. DELIVER ON CRUCIAL GLOBAL STORAGE FOR ALL YOUR SAMPLE TYPES
For subsequent use, resolution of regulatory inquiries, or post-study data collection, maintenance of both sample data and sample viability are essential. Maintaining the samples close to the collection site will minimize samples’ exposure to the stress of shipping. However, not all laboratories have appropriate biostorage capabilities, so due diligence is warranted to ensure that biospecimens will be secured and protected in every location the chosen central lab uses.
- Backup power is an absolute requirement. Power failures happen everywhere, but in many parts of the world, they are routine and can destroy an entire sample collection. Fully validated and mapped backup freezers, backup generators, and redundant HVAC systems are essential to protect samples, long term.
- Space for samples requiring a broad range of conditions, with monitoring 24/7/365, must be available. It is imperative to ensure that the laboratory offers ample space with storage conditions that range from controlled room temperature to 2°–8°C to biomedical freezers (-20°C and -80°C) to cryogenic storage at -190°C. All freezers and refrigerators must be monitored on a continual basis.
- Security must be a consideration. Break-ins, fires, and floods at the laboratory site can place samples at risk. A redundant, whole-building, and biorepository-specific monitored and alarmed security system is an absolute requirement.
- Easy accessibility for prompt retrieval and shipment saves time down the road. Sponsors must be confident that, when needed, samples will be retrieved, shipped, and delivered to their new destinations in a timely manner. Accessioning and inventory management systems must be in place, preferably as part of a centralized database.
Establishing the accuracy, precision and consistency of study samples is of paramount importance if the data are to meet the standards of international regulatory agencies. To ensure results from multiple labs will be considered viable for clinical trial purposes, LabConnect has developed a rigorous program of harmonization procedures to be used in conjunction with an ongoing internal quality control program.
Minimizing shipping time from site to processing lab and standardizing global processes can result in increased recovery and viability of PBMCs as well as better DNA/RNA concentrations and purity. Measures such as the use of well-designed collection and validated shipping materials, standardized analyst certification, and centralized performance monitoring can ensure consistent global laboratory performance. Storage facilities with proper and redundant systems can help avoid catastrophic loss of materials. When choosing a central lab to assist with global sample preparation, a detailed examination of its practices will help ensure desirable results.
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Connect with LabConnect — the preeminent provider of central laboratory support services for analytically and logistically complex studies such as immuno-oncology, cell and gene therapies, and rare and orphan diseases. We offer unique and innovative services that have been specifically designed to meet the exacting demands of today’s clinical trials. Our worldwide scope of services includes routine and specialized testing, real-time sample tracking, data integration, biorepository, sample processing, and specialized functional outsourcing. Leading the evolution in central laboratory services since 2002, our services are customized to fit the unique needs of your trial. Get connected by requesting a proposal at www.labconnect.com or via email at email@example.com.