Analytical Testing & Quality Control

Our team of experts can develop and validate appropriate analytical methods, to assess content, purity, identity and compliance to pharmacopeial requirements and methods. This includes physico-chemical testing and microbiological testing.

Our team can also implement and transfer analytical methods from any 3^rd party.

Our method panel includes a vast range of methods and equipment, allowing us to test a vast range of therapeutic modalities, from small molecules to biologics to others.

We can perform release testing according 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 in order to determine an appropriate shelf life and evaluate product stability. Our GMP 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 frozen state (-20°C, -40°C, <70°C). Additionally, we can perform Photostability testing (according ICH).
For development purposes we would also typically recommend to evaluate interfacial stresses.

We at ten23 health can also support you in characterizing pharmaceutical products of therapeutic modalities, for example comparing any changes and product versions, may it be due to different processing, before/after site transfers, or any formulation, packaging or device changes, etc. Such comparability assessments can also help compare molecules to their physiological counterparts or to any other relevant reference products.

We also provide special analytical services as follows:

• Particle Characterization: we can measure (quantify/quality) particles from submicron, to subvisible (micrometer) to visible sizes, using a range of technologies including light obscuration (employing different systems), microscopy (following PhEur 2.9.19), flow imaging. For visible particle testing, we follow pharmacopeial requirements (PhEur 2.9.20). Particle identification uses for example microscopy and spectroscopy. Additional technologies are available in collaboration such as AUC.
• Container Closure Integrity (CCI):  we can assess container closure integrity and typically recommend deterministic CCI testing using Helium leakage. We can perform these evaluations with a range of 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).