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Our Pace Life Sciences Boston location provides comprehensive Pharmaceutical and CMC Development services for all drug types including small molecules, biologics, and oligonucleotides.  A thorough understanding of the chemical, physicochemical, biophysical, and/or biopharmaceutical character of drug candidates is used to conduct stage-appropriate analytical method development, pre-formulation, formulation and process development activities.   Our highly-trained staff and state-of-the art laboratories are there to assist clients in all aspects of pharmaceutical development from drug candidate nomination to late-stage clinical readiness and beyond.

Technology transfer from our development laboratory in Boston, MA to our Oakdale, MN state-of-the art GMP testing facilities enables our clients to seamlessly and confidently advance their programs to pre-clinical and clinical studies in a manner compliant with regulations and industry standards.

For more information on our numerous CMC development capabilities, please call (781) 305-4940 or email CMCDevelopment@pacelabs.com.

Explore Our Services

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.

Webcast: Understanding Polymorphism to De-Risk Drug Development

Event Overview:

Determining the polymorphism of a drug—the propensity of a molecule to crystallize in different crystalline arrangements, to form crystalline salts and/or non-salt cocrystals—allows for rational selection of the proper solid form/polymorph for further development.   In this webcast, learn about the basic concepts of the physical phenomenon of crystalline polymorphism in drug molecules and the techniques used to discover and characterize polymorphs. Explore the effects that different polymorphs may have during drug dissolution and solubilization in the body and resultant bioavailability levels.  The benefits of understanding possible polymorphs from a commercial business and risk reduction standpoint will be explored.

Key Learning Objectives:

  1. Review the definitions of drug solid form, polymorphism, crystallinity, and amorphicity.
  2. Understand the physical nature of polymorphism and the techniques used to find polymorphs, salts, and cocrystals.
  3. Develop an appreciation of the importance of profiling polymorphism in drugs for the following factors:
    • As a key component of selecting the proper solid form for development
    • As a necessary inclusion in key regulatory filings
    • As an asset for intellectual property filings, which can prevent competitors from legally formulating your drug using a polymorph not under patent protection.

Who Should Attend:

Scientists, managers, and regulatory professionals involved in small molecule drug development, from early-stage preformulation through late-stage approval.

Speakers:

Steven Johnston, P.h.D.
Director Pharmaceutical Development
Pace Analytical Life Sciences

Steven is a 20+ year pharma veteran. He began his career in protein science in crystallography, with key first publications in the ubiquitin/proteasome system (UCH-L3, Reg-alpha) and immunology (IL-12). Steven attained a doctorate in biochemistry from the University of Utah in 1998 and completed post-doctoral work at Wyeth. After post-doc, Steven expanded into structural bioinformatics at the Whitehead Institute, where he created and brought to practice a structural bioinformatics initiative as a member of the Biocomputing Core Facility. Steven later joined the Pharmaceutical Development Department at Vertex Pharmaceuticals in 2005, focusing on small molecule preformulation, solid form discovery and structural elucidation. At Vertex, Steven was a leader on the teams that brought forth three breakthrough drug approvals, Incivek (HCV), Kalydeco (CF) and Orkambi (CF). He is currently a Director of Pharmaceutical Development at Pace Analytical Life Sciences, where he focuses on oral and parenteral delivery of small molecules and peptides/proteins.

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