Imagine the following scenario. You are close to finalizing the development of a new drug or assay before it enters into clinical trials. However, you encounter a slight setback which requires specific cells you are evaluating to be retested in a key experiment….and you don’t have any vials left! These cells are from a unique donor that fits the criteria you are working with. You contact the hospital which you originally obtained samples from, but the donor is no longer available and tracking down a new donor will take time. Important data are now on the line and your competitors are moving fast into the next phase of development. What do you do?
This is a common scenario that can delay the progress of your research and create extra costs in the development of your drug or assay. But it doesn’t have to be this way.
Using a biospecimen provider can prevent such a scenario.
In an ever-changing and fast-paced era of pharmaceutical and biotechnological advances, where costs and time can dictate the progress of your research, a biospecimen provider is the solution. This provider should not only find a specific recallable donor for your research but also deliver a wealth of options and opportunities for providing you with the product you need when you need it.
1. A vast network of sites to reach donors.
The treatment of human ailments is progressing towards precision medicine, therefore the need for specific donors has increased. Tracking down donors that meet your exact requirements, such as demographics, past medical history, disease state, etc., can be difficult if the donor pool is limited. Choosing a biospecimen provider that has a vast network of donor sites, such as their own FDA registered collection centers along with a well-integrated network of hospitals with their own procurement staff, and an established relationship with their donors allows easy and quick access to the right donor, which is essential for advancing your research in a timely and cost-effective manner.
2. An on-site cell manufacturing laboratory.
It is important to optimize the handling and processing time of the biospecimen once it has been collected to reduce molecular changes within the cells. A biospecimen provider with an on-site full-service cell manufacturing laboratory that focuses on your cells main attributes; high viability, purity, recovery, and cell counts, can save you time, resources, and ensure freshness of your cells.
3. Linear traceability of the product.
High-quality biospecimens start with a standardized data-driven workflow. A workflow that focuses on the collection, analysis, and storage of data associated with the administrative and operational processes of the biospecimen, which includes regulatory requirements, collection procedures, primary cell isolation protocols, regulated storage, as well as quality control (QC) and quality assurance (QA), guarantees the integrity and relevance in the quality of the biospecimen, providing confidence in your research.
4. Strict regulatory guidelines.
To ensure operational excellence and consistent quality of the product, a biospecimen provider should comply with FDA CFR 1271 requirements of current Good Manufacturing Practices/Good Tissue Practices (cGMP/cGTP ) regulations covering human cells, tissues or tissue-based cellular products (HCT/Ps). In addition, the provider should operate under strict, approved standard operating procedures (SOPs) that are managed using FDA CFR 1271 compliant software, allowing a streamlined manufacturing operation.
5. Flexibility in product design.
No study is the same, therefore no request is the same. The ability of a biospecimen provider to allow flexibility and customization in the collection, production, testing, and distribution of your order is important for providing the right tissue or cells for your research when you need them.
6. A research support service.
Given the breadth of knowledge and scientific expertise in obtaining, handling, processing, and analyzing human biospecimens, a biospecimen provider moves easily into the role of a partner where goals, hypotheses, and concepts align with your research. As a contract research organization (CROs), a biospecimen provider can offer clinical trial and other research support services that translates to significant cost-savings and closes the gap on time-to-market of your product.
As demands in human studies and advances in medical research become increasingly difficult due to soaring production costs and extensive developmental times, it is important to choose a biospecimen provider that enables you to easily navigate barriers, enhance quality, and drive success in your research and clinical trials.
StemExpress is your premier biospecimen provider, capable of providing you with the highest-quality products to suit your research and clinical needs. With over 2500+ donors and multiple FDA registered Stem Cell Collection Centers throughout the US, StemExpress can track down the right donor for your research easily and quickly. With our on-site GLP regulatory-compliant cell manufacturing laboratories, fresh whole blood products can be processed into a highly pure and viable cell population, vialed, and shipped directly from our facilities in either fresh or frozen formats. The entire process, from donor recruitment to delivery, is managed by strict guidelines and FDA compliant software to ensure the quality, traceability, and timely delivery of your product.
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