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Analytical Program Design

Analytical Team Experience

Analytical Capabilities

The cornerstone of any product development effort is the analytical characterization and validation of all raw materials, bulk solutions, in-process materials, and finished product. Althea’s well-designed analytical programs satisfy regulatory requirements and work to assure the success of the clinical program. Analytical Scientists customize phase-appropriate analytical programs to the specific needs of your unique molecule delivering a comprehensive understanding and characterization of the molecule for each stage of development and commercialization.

You can then make process changes necessary for successful formulation, drug delivery, and vial to syringe fill finish. As your drug product advances through the clinic, we will design and execute analytical programs that support a full characterization of the drug product.

Reference lots or standards are incorporated throughout the analytical program and are utilized as controls for assays used during the development and characterization of your product. Every time your drug product is manufactured, we compare your drug product against the standard to ensure it has comparable quality, purity, strength, and consistency.

Our team’s experience and flexibility in phase-appropriate Analytical Services result in timely and efficient clinical drug development. Althea’s analytical scientists are a highly seasoned team with proven track records in the biopharmaceutical industry. Our scientists have pioneered new applications of biochemical and biophysical analyses for the characterization of many different protein drugs.

Over the last 30 years, our analytics group has shown a successful track record of working closely with regulatory agencies worldwide. The team has been involved with submissions of many of the top commercial drug product successes.

On-site laboratories are equipped with sophisticated analytical instrumentation, enabling scientists to employ a full range of methodologies and techniques to characterize your product and develop test methods that will validate your product’s integrity throughout its life cycle. All laboratory instrumentation is either on a manufacturer’s calibration program or an equipment validation program.

Primary Structure Analysis

  • Peptide mapping via UV-HPLC or LC/MS/MS (QTOF, Ion Trap)
  • Peptide sequencing via LC/MS/MS (QTOF, Ion Trap)

Biophysical Characterization

  • Multi-angle light scattering (MALS)
  • Circular dichroism (CD)
  • Fourier-Transform infrared spectroscopy (FTIR)
  • Differential scanning calorimetry (DSC)
  • Dynamic light scattering (DLS)
  • Second-derivative UV spectroscopy
  • UV/VIS spectroscopy
  • Electrophoretic mobility (Zeta-potential)

Glycan Analysis

  • Monosaccharide composition
  • Oligosaccharide mapping
  • Sialic acid quantitation

HPLC

  • Size-exclusion chromatography
  • Ion-exchange chromatography
  • Affinity-based chromatography
  • Reversed-phase chromatography

Capillary and Conventional Gel Electrophoresis

  • Capillary isoelectric focusing (cIEF)
  • SDS-PAGE
  • Western blot

Process Residuals

  • ELISA
  • qPCR
  • HPLC (antibiotics, IPTG, surfactants, etc.)

Potency Assays

  • Enzymatic activity assays

Particulate Analysis, including sub-10 micron particle characterization

  • Microscopic-flow imaging (MFI)
  • Asymmetric-flow field flow fractionation (A4F)
  • Sub-10 micron particle characterization

Mass Spectrometry (QTOF, Ion Trap)

  • Intact mass
  • Disulfide mapping
  • PEGylation site identification
  • Peptide mapping with LC/MS or LC/MS/MS
  • Identify post translational modifications (oxidation, deamidation)
  • Glycan characterization & linkage-site identification
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