Exploratory

At Scantox we also work with clients when they are in the discovery or early exploratory phases of drug development. Often, we work closely with the client to fulfil their needs in terms of e.g. implementation of new procedures and methods e.g. testing of special equipment. Furthermore, we always offer our clients to come visit us and be present during the study as we know by experience that in the early exploratory stages of drug and medical device development our clients and staff both benefit from such collaborations.

 

Exploratory Toxicology

 

Exploratory non-GLP toxicology is an integrated part of drug discovery. First of all, because these studies are the first to be performed on a new candidate drug that has never been investigated in vivo before. Secondly, exploratory toxicology has been moved into the early phases of the R&D chain to prevent drug candidates with a safety risk from entering later stages of development.

We offer explorative toxicology studies to help our sponsors identify and define the safe therapeutic dose ranges for other preclinical efficacy studies. Additionally, we perform screening studies that quickly and cost effectively identify which compounds are unlikely to succeed in further preclinical development.

Explorative preclinical toxicology studies are intended to assess the onset, severity, and duration of toxic effects, their dose dependency and degree of reversibility. They can encompass dosing regimens from acute (single dose) to chronic (multiple doses). Several routes of exposure (e.g., oral, intravenous, intramuscular, topical, etc.) can be accommodated and multiple species (e.g., rodents, rabbits and minipigs) are available.

We specialize in the conduct of comparative studies in which several compounds are administered to small numbers of rats or mice and limited toxicological assessments are carried out. These studies give an idea of relative toxicity and effect and facilitate selection of one or two candidates for further investigation. We customize our studies to the individual client based on a range of study types:

Dose Range Finding (DRF)

Determination of maximum tolerated dose (MTD) 

Acute single dose toxicity              

Subacute, 7 or 14 days, repeated dose toxicity

Local tolerance

Implant tolerance 

A full complement of toxicology evaluations is available in-house. These evaluations include clinical chemistry, hematology, urinalysis, histopathology, bioanalysis and toxicokinetics.

 

Pharmacokinetics

We perform pharmacokinetic studies in mice, rats, rabbits and minipigs with laboratories, protocols and processes designed specifically to meet the requirements of pharmacokinetics.

Pharmacokinetics is a key activity for evaluating and optimizing new candidates in drug discovery and early drug development. Solid information of the pharmacokinetics of a new drug candidate is of prime importance for the successful outcome of drug discovery projects.

Pharmacokinetic studies are performed before efficacy studies (which are often extensive and costly) to verify that the formulation and dosage will provide adequate drug exposure in the test animal. Well-designed PK studies provide data to assist in the study design and species selection for efficacy and proof of concept studies, including dosing schedule and dose levels.

Drug discovery is often an iterative process, with selection of new compounds with desirable pharmacokinetic profiles for further investigation. Pharmacokinetic screening studies that include fast start-up and quick turnaround time are therefore essential for efficient lead optimization or evaluation of different formulations.

Our experienced study directors will help you set up the pharmacokinetic, pharmacodynamic, or biodistribution studies suitable for your unique research needs. Studies are always customized to the special requirements of the client. From standard screening to more complex studies we will assist in designing the best strategy and protocols. We have experience with small chemical compounds, peptides, proteins, antibodies, nanoparticles and even implants and sustained release depots. Study times range from short term single dose studies of a few hours to long term repeated dose or depot formulation of six months or longer.

Various traditional administration routes are supported, including, SC, IP, PO, IV, and topical administration but we also perform stereotactic brain injection for administration of compounds.

We focus on executing in-life phase services which is our core competence. Many of our sponsors prefer to perform bioanalysis at their own bioanalytical laboratories. However, for clients that do not have these capabilities at hand, we offer professional bioanalytical services in-house.

 

Efficacy 

Preclinical efficacy studies form the fundamental basis of research pharmacology and drug development. In efficacy studies the pharmacological effects of test compounds are investigated in laboratory animal models that have been developed to mimic the human disease. Such studies are of key importance to predict the success of treatment in humans with the disease.

Because preclinical efficacy studies are so critical to the decisions made about a possible future therapy, it is very important that studies done at this stage are based on best practice. This minimizes the risk of discarding a useful therapy, or conversely, taking an unsuccessful compound into further development.

We are a dedicated and highly qualified partner for preclinical efficacy studies. Our competent and experienced team is known for responsiveness and scientific sound study designs. In rodent models we are mostly working within the areas of oncology and diabetology and have also experience with several rare diseases within the orphan drug indications. In porcine models we have established models of dermatology and wound healing and operation facilities for proof of concept studies that involves implants and surgical intervention.

Innovative new therapies often require flexible and client tailored efficacy studies in order to demonstrate early proof of concept. Therefore, as a natural part of our services, we also offer experimental set up and establishment of disease models according to client requirements. When tailoring efficacy studies to the specific requirements of the sponsor, we do our very best to unify the need for pharmacological data collection and optimized animal welfare.

 

Efficacy Models and Study types

We are working with a variety of different disease models. Some of these are well-known as they are frequently used for research procedures of more general nature. Others on the other hand, are specifically designed and customized for special projects. We have substantial experience in establishing and validating customized models, or even developing new models to meet specific requirements in close collaboration with the client.

 

MICE

Xenografts – Oncology Studies

To study the efficacy of anticancer drugs we perform xenograft studies of human cancer cell lines in immunodeficient mice. We also do syngeneic grafts of mouse cancer cell lines to immunocompetent mice when the studies involve anti-cancer agents that trigger involve the immune system in treatment.

We have a long-term experience in setting up xenograft studies with client specific cell lines or cell lines that we already have in house with a high focus on quality, timelines and cost efficiency. Please contact us to hear more about our in-house cell lines or to discuss your client specific set-up. 

Transgenic mouse models – Rare diseases

The mouse is the species of choice for human diseases that can be modelled in transgenic animals. We work with transgenic mouse models within the following areas:

  •  Rare diseases of the blood and blood forming organs
  •  Liposomal storage diseases
  •  Rare neurodegenerative diseases

 

RATS

The rat is the species of choice for specific disease areas, where surgically or chemically induced models have become golden standards. The following, reveals some of the models we have worked with:

  • Kidney damage therapies
  • Haemostasis and blood coagulation
  • Growth hormone replacement therapies
  • Syngeneic tumor grafting studies

 

MICE and RATS

Diabetes

In both mice and rats, we work with models of diabetes and obesity. The list below shows our capabilities within this important area of research and drug development:

  • Dietary induced Obesity and Type 2 diabetes
  • Genetically induced Obesity and Type 2 diabetes (db/db and ob/ob mice; GK and Zucker rats)
  • Appetite regulation in schedule fed animals
  • Streptozotocin induced Type 1 diabetes
  • Genetically induced Type 1 diabetes (NOD mice)

 

RABBITS

We perform studies of immunology and vaccination in rabbits, since this is the traditional animal model for investigations therapies that affect and involve the immune system. Also, long term studies of depot formulations are performed in rabbits.

 

MINIPIGS

One of the things that sets us apart from numerous other preclinical CROs is the use of pigs. In many aspects, pigs are closer to humans than the other commonly used large animal models. Organs such as the heart and kidney are similar in size and anatomy, and pigs are omnivores, with similar metabolism compared to humans.

We conduct studies in the Göttingen minipigs. Göttingen minipigs are chosen for studies when the small size and slow growth of the pigs are important (i.e., when the amount of expensive article is limiting or when long term studies are performed). In pigs, we are experienced within the following models and study types:

  • Immunology / Vaccination
  • Anti-Haemostasis
  • Transdermal and transbuccal delivery
  • Intensive 24 hrs blood sampling studies applying a complete stress-free sampling methodology
  • Wound healing
  • Stoma research
  • Experimental surgery

Especially within the area of experimental surgery, we work in close dialogue with our clients to help them set up new operation procedures and methods for ground-breaking inventions within surgical intervention and therapy. 

Study types

Scantox provide a range of different study types to clients within pharmacology, toxicology and histopathology. Our dedicated and highly qualified staff ensure that our clients are in focus in everything we do. We deliver quality work on time. Different study types are shown below and if the study type you seek is not shown, please get in contact.