Wolfe Laboratories, Inc. (WLI) was a

contract research organization In the life sciences, a contract research organization (CRO) is a company that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis. A CRO may provid ...

(CRO) headquartered in

Woburn, Massachusetts Woburn ( ) is a city in Middlesex County, Massachusetts, Middlesex County, Massachusetts, United States. The population was 40,876 at the 2020 census. Woburn is located north of Boston. Woburn uses Massachusetts' mayor-council form of governme ...

. It provided

research and development Research and development (R&D or R+D), known in Europe as research and technological development (RTD), is the set of innovative activities undertaken by corporations or governments in developing new services or products, and improving existi ...

services as well as GLP analytical services for products in late discovery phase through early clinical phases of drug development. It served clients in

New England New England is a region comprising six states in the Northeastern United States: Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, and Vermont. It is bordered by the state of New York to the west and by the Canadian provinces ...

, the US and internationally. Laboratory operations took place in a large facility. Wolfe Laboratories, LLC was acquired by Pace Analytical in 2017, and is now recognized as Pace Analytical Life Sciences, LLC.

Background

The company was founded by Dr. Janet Wolfe in 1999. Prior to starting WLI, Dr. Wolfe was on the faculty of the

University of Tennessee The University of Tennessee (officially The University of Tennessee, Knoxville; or UT Knoxville; UTK; or UT) is a public land-grant research university in Knoxville, Tennessee. Founded in 1794, two years before Tennessee became the 16th state, ...

Memphis Memphis most commonly refers to: * Memphis, Egypt, a former capital of ancient Egypt * Memphis, Tennessee, a major American city Memphis may also refer to: Places United States * Memphis, Alabama * Memphis, Florida * Memphis, Indiana * Memp ...

, where she was a professor in the Pharmaceutical Chemistry department. Dr. Wolfe perceived an unmet need in the growing pharmaceutical and

biotechnology Biotechnology is the integration of natural sciences and engineering sciences in order to achieve the application of organisms, cells, parts thereof and molecular analogues for products and services. The term ''biotechnology'' was first used b ...

industries for analytical method development and

formulation Formulation is a term used in various senses in various applications, both the material and the abstract or formal. Its fundamental meaning is the putting together of components in appropriate relationships or structures, according to a formul ...

services. She founded the company in the

Boston Boston (), officially the City of Boston, is the state capital and most populous city of the Commonwealth of Massachusetts, as well as the cultural and financial center of the New England region of the United States. It is the 24th- mo ...

area, known for its biotechnology and

pharmaceutical industries The pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications to be administered to patients (or self-administered), with the aim to cure them, vaccinate them, or alleviate symptoms. ...

. The company is part of a growing outsourcing trend that is affecting the drug development industry, particularly in the Boston area. WLI performs pre-formulation and formulation work, consulting,

pharmacokinetics Pharmacokinetics (from Ancient Greek ''pharmakon'' "drug" and ''kinetikos'' "moving, putting in motion"; see chemical kinetics), sometimes abbreviated as PK, is a branch of pharmacology dedicated to determining the fate of substances administered ...

support, in-vitro

ADME ADME is an abbreviation in pharmacokinetics and pharmacology for " absorption, distribution, metabolism, and excretion", and describes the disposition of a pharmaceutical compound within an organism. The four criteria all influence the drug le ...

screens, analytical characterization of API, stability testing and other contract research. It contracts with various companies ranging from early biotechnology startups to established pharmaceutical companies. WLI also offers GLP-compliant services. WLI was selected as one of the "Top 100 Woman-Led Business in Massachusetts" in 2006. Conducted by the Commonwealth Institute and Center for Woman's Leadership at

Babson College Babson College is a private business school in Wellesley, Massachusetts. Established in 1919, its central focus is on entrepreneurship education. It was founded by Roger W. Babson as an all-male business institute, but became coeducational i ...

, the top 100 businesses were identified based on company revenue.

Role

WLI works in the development of drugs between discovery research and

clinical trials Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietar ...

. This stage of the drug development process was highlighted by the

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...

(FDA) as the initial part of the "critical path". WLI is unusual among the independent CRO's in that it houses both the formulation (pharmaceutical formulations) development and the in-vitro ADME/PK laboratories. As late as the 1990s, inadequate appreciation for the translational phase of development led to investment in drug candidates with poor or unsuitable

physicochemical Physical chemistry is the study of macroscopic and microscopic phenomena in chemical systems in terms of the principles, practices, and concepts of physics such as motion, energy, force, time, thermodynamics, quantum chemistry, statistical mecha ...

and ADME properties. In clinical trials, 30 – 40% of drug candidates failed because of unacceptable "drug-like" properties. The company helps clients investigate physicochemical properties that are frequently responsible for the failure of drug candidates, along with poor aqueous

solubility In chemistry, solubility is the ability of a substance, the solute, to form a solution with another substance, the solvent. Insolubility is the opposite property, the inability of the solute to form such a solution. The extent of the solubil ...

and poor aqueous

stability Stability may refer to: Mathematics *Stability theory, the study of the stability of solutions to differential equations and dynamical systems **Asymptotic stability **Linear stability **Lyapunov stability **Orbital stability **Structural stabilit ...

. WLI also identifies and addresses various issues affecting the safety of a drug for human consumption, such as ADME characteristics like inadequate

bioavailability In pharmacology, bioavailability is a subcategory of absorption and is the fraction (%) of an administered drug that reaches the systemic circulation. By definition, when a medication is administered intravenously, its bioavailability is 100%. H ...

, interference (activation or inhibition) with the

Cytochrome P450 Cytochromes P450 (CYPs) are a Protein superfamily, superfamily of enzymes containing heme as a cofactor (biochemistry), cofactor that functions as monooxygenases. In mammals, these proteins oxidize steroids, fatty acids, and xenobiotics, and are ...

complex and unsuitable clearance profiles.

Solubility

Most drug delivery relies on compatibility with the

aqueous An aqueous solution is a solution in which the solvent is water. It is mostly shown in chemical equations by appending (aq) to the relevant chemical formula. For example, a solution of table salt, or sodium chloride (NaCl), in water would be rep ...

environment of the body. WLI specializes in rescuing and optimizing difficult drug candidates so that the product may be suitable for animal and human delivery.Wolfe Laboratories - From Concept to Creation with Confidence
/ref> WLI specializes in complex cases where

excipients An excipient is a substance formulated alongside the active ingredient of a medication, included for the purpose of long-term stabilization, bulking up solid formulations that contain potent active ingredients in small amounts (thus often referred ...

must be used to make compounds soluble, a necessary step for clients to advance their products to

in vivo Studies that are ''in vivo'' (Latin for "within the living"; often not italicized in English) are those in which the effects of various biological entities are tested on whole, living organisms or cells, usually animals, including humans, and ...

trials.

External links

Wolfe Laboratories

References

{{Contract research organization, state=collapsed American companies established in 1999 Companies based in Massachusetts Contract research organizations Watertown, Massachusetts