Be confident about processes
and products with in-depth
data on your side.

On-site labs with our own personnel offer greater control of
samples and timelines, minimizing risk for our customers.

Almost all analytical testing of clinical and commercial injectable products is done by our in-house staff.

With well-equipped, on-site analytical and microbiological laboratories as well as stability chambers, our scientists monitor end-to-end processes to confirm the safety and quality of each batch.

Analytical Services 

We bring extensive experience to your project across all stages to ensure that what you specify is what is delivered.

We do this by implementing a variety of phase-appropriate assays to test your products and materials, in-process and for final release.​

Testing Capabilities

Biological Testing

  • Sterility (state-of-the-art isolator technology)
  • Bacterial endotoxins
  • Culture purity
  • Microbial enumeration / titer
  • Monocyte activation test
  • Culture media growth promotion
  • Imaging microscope
  • Comprehensive cleanroom support

Analytical Testing

  • Gas chromatography (GC)
  • HPLC / UPLC – including UV/VIS, PDA, RI, ELSD, MS, MALS
  • Capillary electrophoresis
  • SDS-PAGE gel electrophoresis / Western blot
  • FT-infrared spectroscopy (FT-IR)
  • UV-visible spectroscopy (standard and variable path length)
  • Osmometry
  • pH
  • Conductivity
  • Near-infrared spectroscopy (NIR)
  • Titration
  • Karl Fischer
  • Total organic carbon
  • Custom dissolution
  • ELISA / multi-modal plate reader
  • Raman spectroscopy

Physical Testing

  • Rotational viscosity
  • Rheometry
  • Differential viscosity
  • Polarimetry
  • Density
  • Extrusion force
  • Delivered volume / volume in container
  • Turbidity
  • Leak detection
  • Refractive index
  • Liquid particle counting – light obscuration and microscopic

ICH Stability Studies

We have extensive experience running ICH-compliant stability studies for early-to-late-stage drug product development programs over multiple years.

We collaborate and guide the design of your studies with a deep understanding of regulatory requirements and the data packages needed to satisfy them, making sure they meet ICH standards, advising on everything from orientation of packaging to ensuring efficient product use.

Capabilities

  • On-site stability chambers
    • 5°C walk-in
    • 20°C walk-in
    • 25°C/60% RH walk-in
    • 30°C/65% RH walk-in
    • 40°C/75% RH walk-in
  • Multiple configurable reach-in chambers
  • Chambers continuously monitored, alarmed, and validated
Contact us to discuss your analytical service needs

Complete CDMO services with decades of experience and expertise.

Maximize Your Manufacturing

As a full-service CDMO, we help simplify complexities for all clinical and commercial aseptic injectable products.

Get to Know More about Lifecore

From facilities and focus, to our people and purpose, learn why customers partner with us for end-to-end solutions.