Method Development and Optimization

SK pharmteco provides full-service method development for our customers based on decades of industry experience. From initial research, including separation mode selection, stationary phase selection, and mobile phase selection, through to lifecycle method improvements, we work closely with customers to produce methods that meet or exceed their analytical needs. We specialize in various LC and GC method development forms, but also provide adept wet chemistry, spectroscopic, microbiological, X-ray diffraction, and particle size method development services. Our cell and gene therapy analytical services encompass method development, method transfers, qualification, and validation services. Our offerings also include contract testing and analytical development for advanced therapies, allowing partners to simplify their outsourced testing strategy. 

Chiral Development

SK pharmteco applies our extensive chiral chromatography development experience to meet the challenges of complex chiral separations. We can help you develop robust normal and reversed-phase chiral separations. 

Forced Degradation and Stability Studies

As a part of formulation development, packaging selection, method development, or method validation, SK pharmteco provides rapid forced degradation evaluations for drug substances and drug products and cell and gene therapies. Stress testing is a requirement of ICH and is enforced through FDA audits. Based on the structure of the API and/or formulation components, we apply multiple degradation conditions to evaluate hydrolysis, oxidation, thermo-stability, and photolysis of the cell and gene therapy, drug substance, and or drug product. These studies are used to screen degradation mechanisms and develop stability-indicating methods. SK pharmteco applies advanced spectroscopic and chromatographic techniques, including NMR and LC-MS, to aid in structural elucidation of degradation products and to confirm degradation pathways. 

Validation / Transfer

SK pharmteco has extensive experience in the validation and transfer of methodology to support pharmaceutical and cell and gene therapy testing for all phases of products. Our team will work with you in determining phase appropriate validations to support product development. We work with a variety of LC and GC equipment to validate methods for assay/purity/impurity determinations. SK pharmteco can draft the necessary validation protocols and reports to support your regulatory and filing needs. Our approach encompasses the FDA domains of safety, potency, purity, stability, and identity throughout product development and manufacturing. 

Typical Validation Properties

  • Specificity
  • Linearity
  • Limit of Detection/Limit of Quantitation
  • Accuracy
  • Precision
  • Ranging Studies
  • Intermediate Precision
  • Robustness Studies
  • Forced Degradation Studies

We also have significant experience in the validation of GC methods to support purity/impurity/residual solvents testing as well as considerable experience in the development of Chiral chiral methods for compounds that are chirally active and thermally stable. We can also develop Ion Chromatography (IC) methods to support testing of counter-ions or for the determination of residual salts. SK pharmteco validates methods for Elemental Impurities to comply with upcoming regulations from USP<232> and USP<233> and ICH Q3D. We have extensive experience with the development of robust sample preparation (digestion) procedures to support testing of a variety of drug substances, drug products and excipients. 

Method Transfers

Upon completion of validations, our laboratory can support your needs in transferring methods to your manufacturing or other external testing sites. SK pharmteco can draft the necessary transfer protocols and reports to support your regulatory and filing needs. 

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