MPI Research - Complete scientific confidence

Contract research organisations provide many services to pharmaceutical companies to improve production processes and help gain competitive advantage. For added value, however, a CRO must prove itself to be more than just a vendor.

MPI Research is a full service contract research organisation (CRO) that partners with biotech and pharmaceutical companies to meet preclinical research needs. Sponsors benefit from MPI Research's well-developed understanding of today's therapeutic and regulatory environments, and this knowledge is anchored in the strength of scientific experience.

With over 75 study directors conducting thousands of studies each year, MPI Research takes pride in being the preferred CRO of many companies, large and small, who want a preclinical partner on the leading edge of the drug development curve.

Comprehensive services

Sponsors can have virtually any type of preclinical study completed at MPI Research, given its full range of capabilities and experience that includes ethical and over-the-counter pharmaceutical medications, recombinant proteins and other biotech products, veterinary products, synthetic organic chemicals, pesticides, petrochemicals, food additives and stem cells.

MPI Research's GLP laboratories are recognised internationally fortheirfor their extensive knowledge and experience in the following areas.

General toxicology and developmental/reproductive toxicology

The company's history has been built on a long tradition of successful general toxicology studies, employing all standard animal models, and using a myriad of dosing routes for submission to both domestic and international regulatory agencies. The developmental and reproductive toxicology studies are designed to identify drugs, biologics or chemicals that affect fertility and early embryonic development, prenatal and postnatal development, and maternal function.


Analytical and bioanalytical chemistry

A full scope of high quality analytical services is available to all sponsors in support of all phases in the drug discovery and development process. Sponsors can take advantage of competence under GLP and cGMP regulatory drivers.


Safety pharmacology

Preclinical safety pharmacology investigations assess the potential for adverse functional consequences subsequent to therapeutic drug treatment; the company's expertise in neurobehavioral assessment and abuse liability research is well known.


Surgery and infusion toxicology

The surgery department offers superior surgical services, state of-the-art equipment, and is known for its experience with cardiac medical devices. The preclinical safety evaluation of a drug via intravenous infusion is typically used to mimic the route of administration and dose regimen intended for human use, and the infusion toxicology team has the expertise to conduct intravenous infusion studies in mice, rats, rabbits, dogs, mini-pigs, and non-human primates.


Drug metabolism and pharmacokinetics

The wide range of DMPK studies, conducted in the new 12,000f2 laboratory dedicated solely to DMPK research, allows the specialisation and streamlining of scheduling, implementation and reporting processes. Via its absorption, distribution, metabolism and excretion services MPI Research assists its sponsors in selecting the appropriate lead compounds for advancement. The discovery pharmacokinetic studies typically begin within five to seven days of receipt of the test article and signed protocol.


Targeted discovery research and immunotoxicology

Targeted discovery research (TDR) services are tailored to expedite the discovery and optimisation of new leads. The TDR unit is experienced with both human and animal stem cells. Sponsors of the immunotoxicology services can count on an experienced team to study the potential adverse effects on the immune system resulting from exposure to pharmacological, chemical or biological materials as part of their overall preclinical or early clinical safety assessment of their compound.


Pathology

The Pathology Department offers four specialised laboratories: clinical pathology, anatomic pathology, necropsy and histology. Sponsors receive expert evaluation and interpretation of pathology data; testing is carried out for samples sent from other MPI Research sites.


Streamlined service

With a broad range of preclinical services being provided, sponsors benefit from the efficiencies of professionals who regularly work together and are knowledgeable of each others' procedures. This streamlines the service delivery process, and CRO management costs are reduced by dealing with just one company, since there is no longer the time-consuming need to qualify and manage multiple vendors.

By outsourcing to the fully GLP/cGMP compliant MPI Research, sponsors gain important advantages. Not only do they benefit from a familiarity with regulatory agencies worldwide, they also have access to high-tech facilities that have benefited from heavy investment. Without these fixed costs being a part of their R&D overhead, clients are able to take full advantage of a robust infrastructure and reallocate their resources to assure maximum effectiveness.


Sponsor-driven growth

At MPI Research, the quality and integrity of its services is paramount, which is why so many sponsors do repeat business with the company. Thus, careful consideration is given to each strategic growth initiative so that these factors are not compromised. Any expansion of facilities is accompanied by proactive growth initiatives for staffing, technology and equipment.

Human resources are especially important, since unsurpassed service quality is impossible to deliver if the staff is not also first rate. By heavily investing in recruitment and training, MPI Research has developed a rigorous selection process at all levels of the organisation, which has resulted in one of the lowest staff turnover rates in the industry. Sponsor requests for timely, top-quality research drive the company's growth.


Commitment to quality

The recent expansion at MPI Research allows the company to accommodate almost any type of preclinical research need. Sponsors are offered on-time study starts and timely reports so that their studies move forward and research objectives are achieved.

Despite the ability to work within a client's timeframe, corners are never cut at MPI Research, underlining its commitment to quality. The company has worked hard to earn its status as a top-quality provider of preclinical research services by developing high internal standards and customer-defined benchmarks. Investments in human and operational infrastructures assure optimal quality that is delivered according to the needs and schedules set forth by sponsors.

MPI Research's services go beyond the modern, fully accredited AAALAC facilities, innovative procedures and scientific expertise. A team of nearly 1,600 employees, ranging from technicians to veterinarians, pathologists and senior-level scientists, is there for every client. Each project, regardless of size, has a study director leading a research team dedicated to providing the close personal attention necessary for the successful execution of the project. This leads to a successful partnership with sponsors to bring products to market in a timely and cost-effective manner.

MPI Research is proud of its long-term relationships with its sponsors and is equally excited about building partnerships with new ones. Most importantly, the company is committed to the success of all sponsors.

MPI Research recognises that vital decisions are based on solid data that will have important implications for a company as well as the world's health-care portfolio. That role is not taken lightly. Every employee welcomes the opportunity to show the client that they have made the right choice in selecting MPI Research as their preclinical drug development partner.

Company profile

MPI Research is based in Mattawan, Michigan, US. Its mission is to provide comprehensive preclinical and early clinical research that meets the requirements of the pharmaceutical, biotechnology, medical device, animal health and chemical industries.

 


Impact of biopharmaceuticals on preclinical CROs

Scott Boley, senior director of general toxicology and infusion toxicology at MPI Research, says the rise of biopharmaceuticals is rapidly changing the way non-clinical trials are conducted.

The only thing certain is change. This axiom holds true for most aspects of today's world and it is certainly a central tenet for drug development. Fifteen years ago, small molecules - chemically synthesised molecules designed to interact with a specific cellular receptor - represented the majority of pharmaceuticals under development.

"It is critical that the CRO selected by pharma and biotech companies has the experience, expertise and equipment necessary to meet their non-clinical safety evaluation needs with this emerging class of compounds."

The landscape has changed over the last ten years and the number of therapies being developed that fall into the category of biopharmaceuticals has exploded. Analysts predict that in the next decade the majority of therapies will fall into this class. For the purposes of this article, the term biopharmaceutical is used interchangeably with the terms biotechnologyderived pharmaceutical, large molecule, biologic or biotherapeutic. In the most general sense, the term biopharmaceutical can be used to refer to anything that is produced by a living cell - bacterial, yeast, mammalian, insect or plant - and may include antibodies, peptides, intact proteins, vaccines and stem cells.

The non-clinical safety programme used to support the development of biopharmaceuticals can differ significantly from that used to support the development of small molecules. Key considerations include the following:

  • Study design. With small molecules, animal studies would typically be conducted in rodent and non-rodent species based on in vitro metabolism profiles. For biopharmaceuticals, regulatory bodies allow the animal studies to be conducted in a single species if the biopharmaceutical is pharmacologically active in only a single species.
  • Safety pharmacology studies. In the case of small molecules, a standard battery of safety pharmacology studies is conducted. For biopharmaceuticals these studies may not be conducted as stand-alone studies; rather, safety pharmacology endpoints may be included in the design of the general toxicology studies. If the biopharmaceutical has known effects on a physiological system, stand-alone safety pharmacology studies may still be needed.
  • Reproductive toxicology studies. For small molecules, reproductive toxicity testing is conducted in two species. If the pharmacological activity of the biopharmaceutical is limited to one species, typically non-human primates (NHPs), reproductive toxicology studies can be conducted solely in NHPs, with the rationale being that, if there is no pharmacological activity of the test article in a particular species, conducting reproductive toxicology studies in that species would not provide meaningful data.
  • Dosing solutions. The preparation of dosing solutions used for non-clinical safety studies with biopharmaceuticals also differs from the preparation of those used for small molecules. For example, biopharmaceuticals are more prone to adhesion than are small molecules and may require specific materials during their formulation (for example, glass instead of plastic). In addition, vigorous homogenisation procedures used during the preparation of small molecules are not used in the preparation of biopharmaceuticals because of their propensity to create bubbles that can denature a protein.
  • Delivery methods. The delivery of biopharmaceuticals presents its own challenges. Biopharmaceuticals cannot be administered orally because they would be broken down in the acidic environment of the stomach before they had an opportunity to become systemically available. Therefore, the common routes of administration are parenteral (subcutaneous, intravenous, intraperitoneal and intramuscular).

These are just a few of the important considerations affecting the non-clinical research industry, which, instead of being driven by small molecules as it has been over the past decade, will now have its growth fuelled largely by biopharmaceuticals.

It is critical that the contract research organisation selected by pharma and biotech companies has the experience, expertise and equipment necessary to meet their non-clinical safety evaluation needs with this emerging class of compounds.

 

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MPI Research
www.mpiresearch.com

The In Vitro Pharmacology team measures a variety of cardiac function parameters using the Langendorff isolated, perfused heart assay.
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