A contract research organization (CRO) provides research services to different companies in a variety of industries. Essentially, they are a company that you can outsource your research and analytical testing services on a contract basis, rather than dedicating time and resources to performing them in-house. CROs are a fixture of the pharmaceutical and medical industries, but many industries utilize this same model, and for good reason.
Using a CRO comes with a number of benefits. Keeping full research studies in-house is very costly for the company. You need specialized, highly skilled personnel to perform many of the tasks required, not to mention the expensive instruments that must be used. The benefits extend beyond cost or resources, though. If you plan on submitting your chemical studies to a regulatory agency, outsourcing them to a third party lab will give the results more weight and legitimacy than submitting results from a study conducted internally.
Because CROs typically offer their services on a contract basis, there is a high potential for customization to tailor services to meet the needs of their clients. These third party labs provide a high degree of expertise, helping their clients problem-solve throughout the duration of the study. This close, constant relationship makes it that much more important to pick the right CRO for your situation.
As you evaluate how you want to move forward with your contract studies and who you want to perform the analytical testing services, there are several important things you need to know about CROs.
Chemicals that have the potential to bioaccumulate in wildlife in humans must be tested. That is where CROs come in. They perform contract studies for chemicals and/or chemical mixtures following procedures and standardized protocols while also offering customization to the process. Even when a chemical mixture contains a very low percentage of an ingredient with the potential to bioaccumulate, some regulatory agencies may recommend that the whole mixture not go into the market. For this reason, it’s incredibly important that these studies be conducted correctly and accurately.
A CRO has the means to help industries contending with this issue find a way to test the whole mixture as well as the individual ingredients. KJ Scientific is doing this right now with fragrance materials in studies contracted by the Research Institute of Fragrance Materials (RIFM), analyzing how ingredients behave individually and in a mixture to provide the most precise results on bioaccumulation potential.
Bioaccumulation potential is determined through metabolism studies utilizing rainbow trout liver S9 subcellular fraction and cryopreserved hepatocytes (liver cells). Other than metabolism studies, CROs may be used for other analytical testing services, such as drug-to-drug interactions and metabolism studies in liver cells of humans and other mammals for the pharmaceutical industry. As a CRO that understands standards and regulations, validation processes, analytical methods, metabolism and chemical testing, KJ Scientific created a subsidiary company, KJ Scientific Independent Testing Laboratories (KJ SCI ITL). In this venture KJ SCI ITL has increased the chemical analytical capabilities and will be testing cannabinoids i.e., cannabidiol (CBD) and tetrahydrocannabinol (THC) for potency, terpenes, pesticides, residual solvents, metals and microbes from extraction in cannabis plants such as hemp.
While CROs are often used during the development and testing of new medicines and drugs, contracting chemical research studies out to third party labs is popular in many industries. In fact, the fragrance industry regularly makes use of the services of CROs. Other industries include oil and gas, pesticides and agrochemicals, pharmaceutical, consumer goods and personal care and any other industry that produces chemicals that fall under regulation by an agency such as REACH or ECHA.
It may surprise you that method development of a chemical will be the longest stage of the process. When you begin working with a CRO, they should begin by asking if you have an analytical method. Once a Non-Disclosure Agreement (NDA) is signed, you can transfer your analytical method to the CRO. At this point, the CRO should validate your method. If they do not validate your methodology prior to moving forward with the study, they aren’t providing you the best service. Part of the reason for working with a third party is to obtain objective, unbiased results that give the study a greater amount of reliability. From here, the CRO’s highly skilled chemists get to work and perform the chemical analysis. This step is critical and requires a great deal of specialization. A lot of time can be spent during this stage of the process because it is crucial to the accuracy of the study. You should verify whether the CRO has the appropriate equipment and expertise to provide accurate testing and results.
They will also do additional method development within their own biological matrices. At KJ Scientific, for example, we use S9 subcellular fractions and cryopreserved hepatocytes sourced from rainbow trout for our metabolism studies. After this, the CRO conducts preliminary range finding studies to determine the optimal conditions for the final metabolism and incubation studies with their biological matrices.
The incubation experiments (in vitro metabolism) generates an average of 80+ samples that take over 24-36 hours to analyze. Through chemical analysis of the compound, a metabolic rate is determined based on the disappearance of the parent compound (chemical of interest or under study) in the presence of S9 subcellular fraction or hepatocytes. This rate is used in the in vitro to in vivo extrapolation (IVIVE) model to determine the Bioconcentration Factor (BCF).
The BCF is an important measurement that regulators use to decide if a chemical goes to market or not. Around the world, regulators have different standards your substance or material must meet. A CRO should be familiar with the regulatory standards of your industry to help you throughout the testing process.
A key reason many companies choose to outsource their analytical testing services to a CRO is the advanced technology required to conduct these studies responsibly. Innovative technology is used with S9 subcellular fractions and cryopreserved hepatocytes to test to perform metabolism studies. To analyze the chemical, gas chromatography (GC), high pressure liquid chromatography (HPLC) and/or liquid chromatography (LC) are used.
CROs are at the forefront of advanced technologies and a source of innovative methodologies. KJ Scientific recently entered a collaboration with AGILENT TECHNOLOGIES in which we will be performing environmental toxicology studies and also be a demo laboratory of the latest gas chromatography triple quad (GC-MS/MS) (Model 8890 GC System/7010B GC/TQ).
At the conclusion of a study, the CRO should compile the findings into a report. At KJ Scientific, we follow the format of a peer reviewed scientific article: abstract, introduction, methodology, results, discussion and appendices with the raw data. By providing you with a thorough, well-documented and well-written report, you will have confidence that the findings you present to regulatory agencies have been rigorously vetted.
Choosing to perform your chemical research studies internally at your company presents you with several obstacles. In terms of resources, these kinds of studies require expensive equipment, experimentation and highly qualified scientists. Receiving findings from a third party lab is also seen as a more cost-effective, trustworthy and the results, more high-quality. Finding the best CRO for your contract study is key, though.
A CRO such as KJ Scientific comes with a high level of expertise to help you through research and experimentation of new chemical mixtures. We are one of seven laboratories that participated in the OECD Ring Trial that resulted in the Test Guidelines 319A and 319B on the determination of in vitro intrinsic clearance using rainbow trout cryopreserved hepatocytes and liver S9 subcellular fractions. We work with our clients both through our services and the products we make to aid them in their own studies.
As a certified Woman Owned Small Business (WOSB) and Historically Underutilized Business (HUB), KJ Scientific is the perfect partner for your experimentation needs, no matter how specialized or niche they may be. Contact us today and learn how we can be a simpler, more cost-effective solution for your analytical testing services.
With our subsidiary, KJ Scientific Independent Testing Labs, we expand our knowledge of environmental toxicology into the hemp CBD testing industry.