Read on to know everything about how contract research organizations function and the wide range of services offered by them.
What is a Contract Research Organization?

What is a Contract Research Organization?

A CRO or contract research organization aims at reducing costs for companies that develop new drugs and medicines in specifically targeted markets. They help companies simplify their entry into drug markets. Nowadays, the need for large pharmaceutical companies to do all their research and testing in-house is a thing of the past. A CRO assumes the role of an independent contractor with a sponsor to design, select, evaluate, monitor and prepare materials that need to be submitted to the Food and Drug Administration (FDA) or other government regulated authorities.

In addition, contract research organizations provide support for clinical trials and clinical studies. Most CROs range from small, niche groups to large international corporations. Being the first stop for toxicological or molecular pathology needs, clients such as academic institutions and other CROs contact them for special technologies or routine histology processing.

Factors to Consider While Hiring a CRO

A competent contract research organization or preclinical contract research organization is a reliable partner for the scientific or regulatory needs of companies. Typically, their work combines the core business of toxicological pathology along with other services such as:

1. Inhalation pathology
2. Bone marrow evaluations
3. Neuropathology
4. Necropsy
5. Histology
6. Routine and special histotechnology
7. Pathology in other laboratory species like fish and birds
8. Foetal and reproductive pathology
9. Image analysis
10. Histopathology and toxicologic pathology
11. Molecular pathology
12. Microscopy technologies

There are various important factors that organizations consider while enlisting the services of a CRO. Some of them are:

1. Patient interaction
2. Laboratory values interpretation
3. Conduction of physical assessments
4. Focus of expertise
5. Collaborating with other professionals and businesses
6. Handling multiple tasks simultaneously
7. Problem-solving abilities
8. Application of medical and scientific knowledge
9. Innovation in thinking
10. State-of-art infrastructure

Services Offered by Contract Research Laboratories

Contract research organizations provide a wide range of comprehensive services. Some of the services offered are listed below:

1. Data entry and validation
2. Project management
3. Reporting of metrics
4. Statistical analysis reports and plans
5. Safety Alliance
6. Quality assurance certification
7. Publications
8. Presentations
9. Professional training and education
10. Collaborations with other businesses/ professionals

In conclusion, the clients of contract research organizations benefit from the services provided in various research fields such as genetics, biomedical engineering, anatomy, toxicologic pathology, regulatory toxicology and much more. Independent, privately-owned CROs are spread all across the globe. Companies based in Europe can contact us for a CRO in Switzerland.

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Read on to know everything about how laboratories conduct TCR analysis and the wide range of TCR services offered by them.

Tissue Cross-Reactivity Study: An Introduction

Generally, a TCR study is done through immunohistochemistry (IHC). The test biologic is a panel of tissues from human or animal species that have been selected for the purpose of evaluating toxicity. In several cases, the staining profiles of animal and human tissues on a test biologic may vary in terms of intensity and distribution. This suggests that the data from a TCR study should be interpreted carefully and on a case-by-case basis in the context of preclinical studies.

TCR studies are very useful in the identification of target organs and target species for toxicology studies. When human tissues are used, the primary goal is the potential identification of cross-reactive and off-target epitopes across a range of tissues. In the case of animal tissues, a TCR study helps in the identification of the most relevant species that have a target expression profile similar to that of humans.

The Importance of Tissue Cross-Reactivity Studies

So why are TCR studies important? They are needed because they are used to support human clinical trials. The process is initiated when a clinical trial application is filed with regulatory authorities for a test biologic. TCR studies form an essential component of the preclinical safety assessment package that is generally offered by laboratories.

The staining pattern and the distribution of staining on the human tissue panel alert investigators to the potential toxicity towards some targeted organs. It also has the possibility of expanding the potential indications that have not been previously identified.

As the primary goal is safety assessment, the intensity of the staining can provide valuable insights into the potential toxicity. Along with data from animal tissue, TCR studies help in the determination of the right kind of species to perform in-vivo toxicity studies to obtain helpful qualitative information on the effect of cross-reacting biologics.

The Applications of Tissue Cross-Reactivity

There are various applications of a TCR analysis. They include:

1. Determining potential risks in patients
2. Compiling a complete tissue bank of a wide variety of species that include infected tumours and tissues, fixed or frozen tissues and in vivo studies
3. Generating high-quality audited reports
4. Digital photomicroscopy
5. Quality assurance
6. Critical phase audits
7. Efficient reporting and scheduling
8. Preparation of study-specific protocols for exact requirements

Tissue Cross-Reactivity Services Offered by Laboratories

Many laboratories provide immunohistochemistry-based tissue cross-reactivity (TCR) studies in compliance with GLP regulations. Some of the TCR services offered are listed below:

1. Preliminary studies
2. Definitive studies: antibody concentrations, tissues and subjects
3. Evaluation of slides and interpretation
4. In vitro cross-reactivity
5. In vivo binding of test articles
6. TCR analysis of potential treatment-related effects
7. Immunophenotyping
8. Preclinical monoclonal safety
9. Clinical trial support: entry criteria, biomarkers
10. Final report

In conclusion, a tissue cross-reactivity study helps in a better understanding of the difference and similarities of drug target localization as well as the expression between various species. Many laboratories use the Leica Bond-III system that is known for its consistent and reliable results.

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The purpose of performing a necropsy is to determine the cause of death of the animal, and the procedure varies depending upon the size, age, and other historical information. The process of a necropsy generally includes a complete postmortem gross necropsy examination as well as a microscopic examination i.e., histopathology of selected tissues, if required.

What Does a Necropsy Involve?

In technical terms, a necropsy examination refers to the dissection of the body of a deceased animal in order to be able to determine the time and potential cause of death. It also helps establish the absence or presence of contagious or infectious diseases. Additionally, a necropsy laboratory documents the presence of injury, trauma or abuse in an animal.

As mentioned earlier, histopathology refers to the process of evaluating the tissue samples collected during the necropsy with a microscope. These tissue samples must first be fixed in formaldehyde or formalin and then trimmed. This technique is implemented for microscopic slide preparation during special processing.

Additional Tests During a Necropsy

Sometimes further testing may be required such as microbiology, radiology, toxicology, and immunohistochemistry. Toxicologists and pathologists perform scientific tests on the animal’s bodily fluids and tissue samples to identify chemicals or drugs present in their system. Through the use of highly sophisticated equipment, chemical reagents and precise methodologies in necropsy laboratories, they can determine the absence or presence of specific toxic substances in the animal tissue sample.

Necropsy laboratories also use the medical specialty of radiology to diagnose diseases through medical imaging. This includes imaging techniques such as an X-ray, ultrasound, magnetic resonance imaging (MRI), positron emission tomography (PET) and computed tomography (CT) scans.

Types of Necropsy Services

Laboratories that perform necropsy services have teams that are well-trained in all aspects of the requisite procedures. These may include special tissue harvesting for biomedical devices such as implants and stents, reproductive studies as well as PCR analysis. They are also well-versed in the use of whole-body and organ perfusion technology. This technology is routinely employed in conjunction with neurotoxicological protocols and studies that have ultrastructural requirements.

A few of the services offered by necropsy laboratories are mentioned below:

1. Travelling team of necropsy experts that provide training and support
2. Supervision of necropsy procedures by certified pathologists
3. Specialized tissue collection which includes whole-body and organ perfusion
4. Freezing of tissues for molecular pathology such as immunohistochemistry (IHC)
5. Tissue collection techniques for the purpose of PCR analysis
6. Providing an in-depth understanding of regulatory guidelines and specifications.

The Importance of Necropsy Services

The work done in a necropsy laboratory greatly contributes to scientific knowledge by helping to increase the understanding of animal anatomy and physiology in health and disease. Necropsies complement clinical medicine by providing an invaluable educational tool for pathologists and lab technicians. They also help save lives by alerting pathologists to the presence of diseases that could potentially be transmitted to other animals or even humans. Public health authorities and regulatory veterinarians use necropsy as a surveillance tool in order to monitor emerging or foreign animal diseases.

In a necropsy laboratory setting, the postmortem examination is often used to help determine the safety and effectiveness of new pharmaceuticals before they are launched in clinical trials. It also serves important legal functions i.e. it provides photographic and written documentation of the post-mortem findings that are critical in cruelty and insurance investigations.

How Necropsy Laboratories Work

Sometimes, necropsy laboratories support contract research organizations (CRO), chemical, agricultural and pharmaceutical industries. This is done when there is a special requirement such as perfusion technology or during times of heavy workload. They may also provide support for Developmental And Reproductive Toxicology (DART) studies for clients. This is done by conducting a caesarean section as well as the external examination of rat and rabbit foetuses. Most necropsy laboratories are equipped with state-of-the-art equipment to provide fast, accurate and reliable results to their clients.

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The study of biological tissue is called histology. It is also known as microanatomy because it involves studying plant, animal and human tissue under a light microscope or an electron microscope. A thin slice of tissue is placed under the microscope and examined after staining. Staining helps in distinguishing various biological structures more easily and accurately. The colours enhance certain types of these structures that may be located next to/in contact with each other. It helps seeing deviations in a clearer way.

What are the Key Stages in Preparing Histology Slides?

There are various techniques that can be used to make histological sections for microscopy. For light microscopes, there are three types of techniques that can be used:

• Paraffin technique
• Frozen sections
• Semithin sections

The most commonly used technique in a histology laboratory is the paraffin technique.

Paraffin Technique

The paraffin technique involves fixing tissues and embedding them in wax to maintain the hardness of the tissues. This makes them easier to slice and examine under a microscope. The process involves the following steps:

• Fixation: Whole organs or spare blocks of tissue are fixed by chemical fixation. The added chemical binds and cross-links some proteins, along with denaturing other proteins by dehydrating them. This process hardens the fixed tissues and prevents degradation by inactivating enzymes. It enhances the staining process and kills bacteria at the same time.

• Dehydration and embedding: After fixation, the tissue is dehydrated and embedded. By dehydrating, all the water from the tissue is removed, which allows it to be embedded in a paraffin solvent called ‘xylene’ as paraffin is not soluble in water. After embedding with paraffin, the sample will solidify.

• Sectioning: After the tissue is solidified, it is trimmed and mounted on a microtome, which gives a cut at around 100 μm. The cut is stained and then put on a slide. The cut needs also colored to be able to distinguish different tissue types and cells. There are several staining methods. The choice of staining depends upon what needs to be investigated and examined.The colored section is studied with advanced histological technology and from these samples written finally a report. The process may look different depending on what type of study it is, something that also applies to the process time.

Frozen Sections

In this method, tissues are frozen with liquid nitrogen. They are then cut in a refrigerated cabinet, also known as a cyrostat, with the help of a cold knife. Then, the slice is stained and mounted on a microscope for observation. This is a much faster method and the sections created are 5 – 10 µm thick.

Semithin Sections

The sections are embedded in epoxy or acrylic resin to create sections that are thinner than less than 2 µm. This is done because it is sometimes hard to see details in thicker sections.

What are the Uses of Histology?

Histology is used to investigate various types of tissues. A histology CRO examines the contents of the tissue. Histology can also be used to investigate agricultural land, for example, in order to observe chemicals that can be found in the soil. Histology is also used for autopsies.

What are Some Other Histology Services?

There are many histology services, including neuropathological histology. This field investigates nerves to find diseases, nerve damage and the like. A histological examination can confirm a diagnosis.

The histology process for these types of studies differs from the routine histology. Other examples of histology services are:

• Autopsy
• Histology of special species (fish, birds, etc.)
• Plastic injection for neurotoxic studies
• Histological and toxicological pathology
• Reproductive and fetal pathology
• Molecular pathology

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Poison is any chemical that is toxic and can cause serious harm to the body. Toxicologists conduct toxicology research and aim to study these poisons and gain the following understanding from them:

• Detection of poison
• Occurrence of poison
• The properties of poison
• The effects of poison
• Treatment options for the poison
• Regulation for the poison

They do this in order to protect humans and the environment from different toxicants and their hazardous effects. The study and toxicology testing for various toxic elements will eventually lead to an improved and more innovative set of therapies that can be used to treat ailments after the reduction of the toxic potential to the human body.

Types of Toxicology

The different types of toxicology are listed below:

• Analytical toxicology: This includes the detection and evaluation of toxic chemicals.
• Applied toxicology: Applied toxicology is concerned with the application of modern technology in the early detection of toxicants.
• Clinical toxicology: Clinical toxicology is the study of diagnosis and treatment of poisons, mainly in humans.
• Veterinary toxicology: It is the study of diagnosis and treatment of poisons, mainly in animals and the potential of transference to humans.
• Forensic toxicology: Forensic toxicology deals with the medical investigation of the death, poisoning and drug use.
• Environment toxicology: Environment toxicology is the study of the presence of toxicants in the environment and their effect on humans and animals.
• Industrial toxicology: It is a selective area of environment toxicology.

Factors that Affect Chemical Toxicity

The goal of toxicology research and toxicology testing is to identify the adverse effects of different toxicants. The adverse effects depend on two main factors, which are the routes of exposure and the dose, which is the concentration of the exposure.

The factors that affect chemical toxicity are as follows:

• Dosage: acute exposure (large single exposures) and chronic exposure (small and continuous exposures)
• Route of Exposure: ingestion, skin absorption or inhalation
• Species
• Age
• Sex
• Health
• Environment
• Individual characteristics

What is Toxicologic Pathology?

Toxicologic pathology is the integration of pathology and toxicology. Pathology is concerned with the nature of disease and evaluating the changes that are produced in the cells, tissues, organs or body fluids in response to various ‘challenges’ they may face. Toxicologic pathology requires extensive knowledge in the fields of toxicology, pathology and various other fields such as statistics and experimental design, and sometimes even molecular biology and toxicogenomics.

It plays a crucial role in assessing the safety of non-human primates which are used in the development of drugs. This is done through the identification and interpretation of microscopic tissue changes. The accurate representation process (identification and interpretation) of these histopathologic changes includes study design, organ weights, treatment and historical control data, along with the proper usage of terminology, thresholds and quality control. Another critical aspect is having a solid understanding of microscopic changes in non-human primates which are used in nonclinical research.

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There are a number of things to know to setup a histopathology laboratory of their own. They need to have their facts in place as it is a huge and equally complicated scientific domain. The histopathology services that companies avail particularly involve studying histopathology images to know the cause of a disease and accordingly provide results. To explain further, we shall now look at the most important things that companies must be aware of before getting into the field of histopathology.

What is Histopathology?

Histopathology is the process of examining tissues to know more about the disease and the root cause behind it. The tissues are observed under a microscope in a histopathology laboratory. The process involves conducting a biopsy. Before starting the examination, the tissue is prepared, after which it gets treated and then analysed. Histopathology services are availed keeping in mind the type of tissue being examined as well as the type of investigation conducted.

Why is Histopathology Important?

This field of study if extremely crucial as it enables histopathologists in understanding and detecting diseases. Histopathology enables professionals to look for changes in cells that explain the actual cause of the patient’s illness. Pathologists are able to reach a diagnosis by examining a small piece of tissue from various organs. Histopathology is vital as it broadens and progresses treatments options.

Services Involved in Histopathology

A histopathology laboratory avails a number of services that involve examining the tissues and ultimately detect diseases. The complete range of services offered by laboratories include techniques like necropsy to sophisticated histological processing, as well as expert evaluation by pathologists. These histopathology services are availed in order to know the cause and provide appropriate results. The other additional services offered are:

• Specialized histochemical stains for specific cellular components
• Plastic processing for producing thin sections in support of reproductive pathology and neuropathology
• Plastic embedding for microtomy of hard tissues and devices and peripheral nerves
• Frozen tissue processing and sectioning

Role of Histopathologists

A histopathologist is the professional working in the field of histopathology. The primary task of these professionals is to study histopathology images received from the examination. Their role also involves writing reports on specimens, consult literature and many also have teaching and research responsibilities. They also attend multidisciplinary meetings to discuss their findings and research with other clinicians. Histopathologists also work directly with patients while conducting various kinds of procedures. Their work involves examining cells in smears, aspirates or bodily fluids.

With all the mentioned points to consider, it is imperative for companies to understand the background, processes and facts about histopathology before diving into this field of science.

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