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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.

On-Demand Webcast: Preformulation of Small Molecule Drugs


Event Overview:

Preformulation studies play a significant role in developing approaches to analytical and formulation development based on the physicochemical properties of small-molecule pharmaceuticals. Data collected during pre-formulation informs:

  • Dosage form selection and design
  • Excipient choice
  • Understanding of the feasibility of drug product development
  • Regulatory strategies

This webcast will provide insights into the preformulation phase of drug development and will illustrate common issues encountered.

 

Key Learning Objectives:

  • To identify the typical experiments performed in preformulation of small molecules
  • To recognize how physicochemical properties will affect the choice of dosage form
  • To spot potential formulation issues that could have been prevented by pre-formulation activities

Who Should Attend:

  • Executives in charge of cmc development of new small-molecule drugs
  • Formulation and analytical scientists

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