Analytical Testing & Quality Control

We provide cGMP-compliant QC release and stability testing for clinical and commercial sterile drug products, covering physico-chemical and microbiological endpoints. Our qualified stability chambers accommodate refrigerated, frozen and ICH conditions and we offer photostability and stress testing to establish robust shelf life and product stability profiles.

We perform release and stability services, either in combination with Development or Drug Product Manufacturing, or as a stand-alone service. We can perform QC release testing according to cGMP for clinical and commercial Drug Products, including physico-chemical and microbiological testing, including identity, content, purity, and pharmacopeial and microbiological endpoints.
Stability testing is required to determine an appropriate shelf life and evaluate product stability. Our qualified walk-in stability chambers include refrigerated (2-8°C), 25°C/60% r.h, 30°C/65% r.h., 40°C/75% r.h. and we can also evaluate stability in a frozen state (-20°C, -40°C, <70°C). Additionally, we can perform Photostability testing (according to ICH).
For development purposes we would also typically recommend evaluating interfacial stresses.

We support detailed product characterization and comparability assessments for formulation, process, packaging or device changes, ensuring consistency and equivalence across versions, site transfers and against physiological or reference products.

We also provide special analytical services as follows:

• Particle Characterization: Utilizing a range of advanced instruments and technologies—such as nanoparticle tracking analysis, light obscuration, and flow imaging—we can measure and count particles within the submicron to subvisible size range. We can provide insight into particle morphology, enabling effective classification and differentiation.
• Particle Identification: Identification is performed through digital microscopy and FTIR spectroscopy, supported by complementary analytical methods for enhanced accuracy and details.
• Pharmacopeial Testing: Key pharmacopeial analyses can be conducted in compliance with ISO standards and cGMP requirements.
• Container Closure Integrity (CCI) Testing:  we can assess container closure integrity and typically recommend deterministic CCI testing using Helium leakage. We can perform these evaluations with various container options including polymer containers. We can also support other CCI assessments.
• Device functionality testing:  our assessments can include functionality testing for syringes, cartridges, or other functional containers. This would include break-loose and glide-force testing (BLGF).