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Complex Formulation Support

A major hurdle in the development of biopharmaceutical agents (proteins, oligonucleotides and peptides) is the delivery of these high molecular weight molecules to the target sites. Several formulation strategies have recently been developed which include the use of cationic lipids and encapsulation in liposomes and nanoparticles, just to name a few. As those working in this field can attest, analysis of a pure biopolymer drug substance is a major analytical challenge in itself. Formulating these complex molecules in novel delivery systems creates unprecedented analytical hurdles.

Accugent Laboratories has spent a number of years supporting the analytical needs of complex drugs and delivery systems.

Some examples of our recent projects are described below:

PEGylated oligonucleotides

  • Optimization of PEGylation reactions
  • Development of purification procedures to minimize peroxide formation for improved product stability
  • Evaluation of PEGylating agents from various vendors
  • Pilot formulation manufacturing and stability studies

siRNAs

  • Preformulation studies
  • Formulation development for parenteral, intravitreal and topical dosing
  • Dosage form method development (Duplex analysis by SEC; denaturing methods for the single strands)
  • Freeze-thaw studies
  • Pilot formulation batch manufacture
  • Preliminary formulation stability for IND filing

Cationic Lipids

  • Assay procedures for a novel cationic lipid

Antisense Oligonucleotide in a novel oral dosage form

  • Method development for purity and stability analysis
  • Physicochemical characterization
  • Forced degradation studies
  • Pilot Stability study of dosage form for European IMPD filing

Nanoparticles

  • Optimization of novel oligonucleotide formulation for nanoparticles

Dendrimers

  • Development of stability-indicating methods
  • Chemical reactivity and stability under stress conditions
  • Forced degradation studies (pH, heat, oxidation and light)
Liposomes
  • Determination of encapsulation efficiency
  • Analysis of drug inside and outside the liposome
  • Stability of drugs within the liposomes

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Updated January 7, 2013
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