Cell culture is a method to grow or maintain cells in the laboratory to mimic an in vivo process or for a specialized function. The cells may be primary such as blood cells or freshly obtained from an animal usually with limited cell proliferation, or a cell line with unlimited proliferation.
Cells often vary in their characteristics depending on their growth phase, starting out from a frozen ampoule, in log growth phase, or reaching stationary phase. Understanding the conditions and methods for any specific cell type needs to be considered and tailored appropriately. Without a healthy cell culture, any cell- based assay or bioassay is subject to lack of reproducibility. The awareness of what is required to grow healthy cells is where our expertise shines most brightly.
Our practices require that we monitor the health of our cells all the time. We have performed 1000s of studies on the variables of cell culture, including observing the cells microscopically to determine whether they have blebs, vesicles, are irregularly shaped, grow in clusters (if not normal), are in plateau (not log growth), and a variety of other observational anomalies. When cells change their morphology, the metabolism is altered, and they may not return to their normal condition with the expected gene expression when the media used will influence the health of cells. The single most undefined reagent is the serum. Fetal calf serum, as an example, varies from batch to batch and vendor to vendor. We work to understand this variable and eliminate it as a risk for future experiments, often by acquiring volumes to last for months or even years’ worth of experiments.
When you need an assay to prove your science and there is no commercial kit available, you need a custom assay. Our extensive expertise will quickly and methodically develop your assay to prepare it for eventual validation. Typically an assay can be developed from scratch in 5 or less experiments while minimizing any matrix effects.
We are firm believers in kits. The analytical portion of the assay itself is only a single component of what it takes to perform a successful experiment. It is all the other skills, experience and GLP/GMP conditions that we do day in and day out that will save you time getting to the results you actually want yesterday. We can create and distribute kits, too.
Many companies planning an IND submission or in Phase I/II may only require a well-qualified assay rather than a fully validated assay. You may or may not need GLP/GMP stringency and auditability yet. Our scientific team works with your scientists to qualify your assay for reproducibility, appropriate precision and accuracy.
To validate an assay is to measure precision, linearity, accuracy, robustness, system suitability and repeatability. To achieve these results, we conduct multiple experiments in a pre-validation phase with the assay. This phase is a series of 2-4 experiments that specifically look at these capabilities. Once we have advanced an assay, we perform the assay 2 more times for a total of 3 identical repeats. At that point, your assay meets the FDA GLP or GMP requirements.
Whether patient samples or drug product samples we will map out a timeline and follow through with sample receipts, meeting your regulatory needs at all points. We perform your assay as developed, qualified or validated, and promptly communicate the results and/or Certificate of Testing for any or all of your preclinical or clinical phases.
Knowing the importance to the FDA of lot release potency testing, our scientific team tests every manufacturing lot with your assay providing Certificates of Testing in a timely manner, under GMP Condition.
In order to determine shelf life for a particular drug substance, stability tests are performed at pre-determined calendar intervals. Our project coordinators communicate closely with you to anticipate the arrival of samples so as to have our staff and resources available for timely analysis and submittal of data and Certificates of Testing.
Our cell biologists have been practicing and refining the Art of Cell Culture for over 30 years, performing cell-based (bioassays) here since 1995. Over this time, we have learned volumes about better practices, providing our clients with an extremely high level of success in the earliest stages of work with a consistency of bioassay performance that we are told is remarkable. This is likely a contributing reason why our Clients return for project after project.