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Pace Life Sciences’ Boston facility, formerly Wolfe Laboratories, develops robust, stage-appropriate drug products with concomitant process understanding by leveraging analytical methods, physicochemical, biopharmaceutical, and/or biophysical characterization.

The Wolfe Labs location delivers high-quality translational drug development services for a global base of pharmaceutical and biotechnology clients. Our scientific teams provide leading-edge, integrated solutions to advance breakthrough medicines. Wolfe Laboratories, as part of Pace Analytical, is a leading drug development contract research organization (CRO), bridging discovery through early clinical studies in the pharmaceutical sciences. As part of Pace Analytical, Wolfe Laboratories provides clients with an easy transition to state-of-the art GMP testing services that enable our clients to seamlessly and confidently advance their programs through pre-clinical and clinical studies to commercialization in a manner compliant with regulations and industry standards.

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Pharmaceuticals / Small Molecules

The unique chemical and pharmaceutical properties of each therapeutic moiety must be considered when developing formulations for various routes of administration, whether it is an injectable, oral, or topical dosage form. Solubility, stability, degradation pathways, solid-state properties and biopharmaceutical properties all must be characterized to yield an integrated understanding of the molecule. Wolfe Laboratories’ contract research organization services integrate CMC development functions, analytical, pre-formulation, formulation development, process development, to ensure that test methods and formulations are built on a solid molecular understanding.

Biopharmaceuticals / Biologicals

Pace Analytical Life Sciences applies a rational and science-driven approach towards the development of biologic compounds, based on in-depth understanding of a compound’s physicochemical and biophysical behavior. Our formulation CRO services team develops liquid, lyophilized, and high-concentration biologics formulations. Additionally, the team is experienced in developing non-traditional dosage forms for biologics. Our experts characterize higher order structure and behavior to de-risk process development and yield process understanding.

Protein Drug Conjugates

Attaching active small molecules to proteins is a strategy that is being employed for drug targeting or to enhance the activity of the protein. These conjugates represent a growing segment of therapeutic molecules in the global pharmaceutical pipeline, which includes Antibody-Drug Conjugates (ADCs) as well as biopolymer-drug constructs. The Wolfe Laboratories team has extensive experience in developing analytical and characterization techniques, formulations, and drug product processes.

Oligonucleotides

Oligonucleotides are a rapidly growing new class of biotherapeutics. Pace Analytical Life Sciences offers a full array of oligonucleotide contract research organization services for RNA (siRNA, miRNA, mRNA, PMOs, PPMOs, and others) and DNA, as well as various delivery vehicles (aqueous solutions, lyophilized products, LNPs, VLPs, viral vectors, etc.). Our specialized platform includes specific strategies for characterization, duplex partner annealing, secondary structure analysis, physical property analysis of nucleic acid particles in solution, purity and quantitation of primary components and degradation products, formulation development/characterization, and drug product process development. Establishing a robust process for oligonucleotide drug production streamlines and de-risks pre-clinical and clinical development.

About Wolfe Laboratories

Wolfe Laboratories Logo

Clients have relied on the company since 1999 for ongoing functional support as well as for discrete projects that integrate Wolfe Laboratories’ drug development functions, which include analytical, preformulation, DMPK, formulation and process development, and GLP/GMP testing.

Wolfe Laboratories Offers:

  • Analytical methods to provide insight regarding the molecules and attributes being studied
  • Preformulation studies inform how the molecule will behave in pharmaceutically relevant environments
  • Biopharmaceutical properties (permeability, partition coefficient, plasma protein binding, metabolic stability, metabolite ID, etc.) inform formulation development and are evaluated in parallel with preformulation
  • Rational formulation development integrates the knowledge gained regarding the pharmaceutical and biopharmaceutical properties, and includes assessment of performance in biorelevant media
  • Types of formulations include lyophilized, parenteral (injectable), oral, topicals and other dosage forms
  • Types of molecules include small molecules, peptides, proteins, oligonucleotides, small molecule-macromolecule hybrids, highly-potent, cytotoxic and controlled substances
  • In-house manufacturing to support preclinical studies
  • GLP and non-GLP bioanalytical testing

Wolfe Laboratories integrates these interdependent functions during early drug development to ensure that our client’s novel molecules are advanced into the clinic and that molecules with unsuitable properties are identified before scarce resources are expended on their development. For more than twenty years, Wolfe Laboratories has served a critical role in the development and commercialization of novel therapeutics. Wolfe Laboratories integrated with Pace Analytical in 2017, and began to operate as Pace Analytical Life Sciences in 2019. Our mission has always been to improve human health, and our added resources allow us to continue that mission on a larger scale.

Address: 19 Presidential Way, Woburn, MA 01801

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