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As new cases of COVID-19 soar, experts warn about the newly emerged COVID subvariant BA.5, a sub-lineage of BA.2. Subvariants of Omicron BA.1 emerged in 2021, BA.2 in early 2022 and BA.5 came in April 2022.read more
There have been over half billion cases of SARS CoV-2 (COVID-19) globally since the pandemic began. The majority of infected persons have been either asymptomatic or have experienced a mild acute infection from which they recover within a few weeks.read more
The US FDA requires that licensed products pass critical analysis before release by the manufacturer for clinical use. These include potency, sterility, purity and identity. Potency is used to ensure consistency and efficacy in the manufacturer's product used for stability and lot release.read more
Stability studies are performed to ensure that pharmaceutical products will be at the acceptable level of quality throughout the period that they are available in the marketplace and fit for consumption by the consumer up to the expiry date.read more
Now that Christmas and many other celebrations gather people around a table, it is important to know about the risks we take and the science behind them. Vaccines are the number one weapon humankind has developedread more
Regeneron’s antibody cocktail for treatment of COVID-19 infection (REGEN-COV, comprised of monoclonals casirivimab and imdevimab) was approved by the FDA in October 2020read more
In a classic case of Darwinian selection, the successful Delta variant (B.1.617.2) has largely displaced all other forms of the coronavirus underlying the ongoing global pandemic.read more
Recombinant monoclonal antibodies are one of the most promising drugs (immunotherapy) for human diseases which include infectious diseases, cancer, and various other diseases.read more
Therapeutic antibodies have become an important class of protein drugs for the treatment of numerous human diseases as well as uses in immunoassays. Nearly 100 monoclonal antibody-based drugs have been approved for the treatment of immunologic diseases and cancerread more
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.
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.
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.
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.
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.
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.
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.