State-of-the-Art Equipment and Methods

Within the broad range of services provided by our analytical laboratories and expert teams, specialized equipment and methodologies are used to ensure product quality and to verify processes across all stages of drug product development (DPD). Adhering to quality by design principles (QbD), product and process analysis is performed using our state-of-the-art instruments to ensure optimal formulations and manufacturing processes while further mechanical testing and other analytical methods are used to verify function of vials, pre-filled syringes (PFS), autoinjectors (AI), and other combination products.

High-throughput and Automation Instrumentation supporting Formulation and Process Development

MFI – sub visible particles
HIAC – sub visible particles
Flex-P – automated visible particle imaging system
FTIR microscope – particle identification
DLS – nano scale size distribution
DLS plate reader – high throughput testing of size, Tagg and Kd
Freeze-drying microscope – Tc for lyophilization cycle development
mDSC – Tg’
PEAQ DSC & VP DSC – conformational stability evaluation
cIEF – charge heterogeneity testing
Material tester – break-loose force, gliding force, cap removal force
Rheometer – viscosity and rheology
Uncle – all-in-one stability screening
Force tensiometer – surface tension related measurement
Microfluidic modulation spectroscopy – secondary structure analysis
Image Dimension Measurement System – for PFS

Densitometer – density measurement
HPLC / UPLC – SEC, CEX, RP analysis
High throughput work station for buffer exchange
Automated sample preparation and testing system
High throughput protein quantification system – testing of concentration and turbidity
CG-MALS – mechanism of aggregation and nucleation
Freeze / thaw system – freeze & thaw process development and stability studies using a minimal amount of product
Microfluidizer – nanocrystalline / nanoparticle / nanoemulsion formation
Headspace analyzer – container and closure integrity testing
Silicone oil distribution analyzer – for PFS
Microfluidizer Processor – for nanoparticle
Nano Liposome Extruder – for nanoparticle
Low Field Nuclear Magnetic Resonance – moisture content and protein concentration

mDSC
DLS plate reader
Rheometer
Freeze-drying microscope
DSC
FTIR microscope
Automated screening station
High throughput buffer exchange
CG-MALS
Filling line
Lyophilizer
Freeze-thaw System
MFI
Headspace analyzer
Silicone oil distribution analyzer
Uncle
Force Tensiometer
Microfluidic Modulation Spectroscopy

mDSC

DLS plate reader

Rheometer

Freeze-drying microscope

DSC

Automated screening station

High throughput buffer exchange

CG-MALS

Filling line

Lyophilizer

Freeze-thaw System

MFI

Headspace analyzer

Silicone oil distribution analyzer

In addition to DPD, our analytical testing teams provide the entire spectrum of analytical development services (biochemical, biophysical, physicochemical, biological and compendial assays), and biosafety testing to support our biologics discovery R&D teams and CMC development processes. Go here to see the full range of our comprehensive analytical capabilities or contact us to learn more