We offer comprehensive biopharmaceutical testing services. We ensure phase appropriate analytics and allow for scalable solutions.
Comprehensive biopharmaceutical testing services
At NorthX Biologics, we provide an extensive range of testing services tailored to the advanced products we manufacture. Our expertise encompasses most biologics, such as RNA/DNA, recombinant proteins and enzymes, peptides, and particle-based vaccines (OMVs, LNPs etc.).
Our analytical service portfolio includes:
- Analytical Development
- Method Validation
- Release Testing
- ICH Stability Testing
- Routine Quality Control (QC) Testing
- Cell Bank Characterization & Testing
- Certified BSL2 and BSL3 laboratories
Analytical Development Services
Our Analytical Development (AD) and Quality Control (QC) teams work closely together to ensure smooth method transfer into QC, aligned with ICH Q14 and ICH Q2(R2) guidelines for development and phase-appropriate qualification/validation.
We verify compendial methods and conduct screenings or pre-tests for generic analytical methods, ensuring reliable results for your biopharmaceutical products.
We welcome client involvement during method development and set-up, whether you wish to participate on-site or entrust us with full responsibility. Our team is committed to meeting your needs with the highest quality standards.
Quality Control
At NorthX Biologics, we can cover most of your needs regarding identity, purity, potency, safety, content, impurities and physiochemical testing of drug substance and drug product.
If we cannot cover your needs with our in-house technology, we will manage any outsourcing needs through our approved vendors.
Our services for product-specific release analytics include:
- Method development (if applicable) and transfer
- Verification of compendial methods
- Qualification/validation of product-specific methods
- Release analytics of drug substance/drug product
Stability Studies
We provide stability studies for drug substance, drug product and reference material. Through careful record-keeping and reporting, we ensure that all stability studies are conducted transparently, controlled, and are thoroughly documented.
- Real time and accelerated stability testing
- Long-term stability studies
- Forced degradation studies
Analytical Technology
NorthX Biologics offers state-of-the-art analytical technology, including:
- Five UPLC systems with UV detectors (SEC, RT, IP-RP)
- UV Spectrophotometers (UV/Vis)
- FluoStar Omega (HCP, BCA, ELISA, colorimetric assays, potency assays)
- BioTek ELx808 (Endotoxin; Kinetic chromatogenic)
- SevenExcellence S470 (pH)
- Gel electrophoresis (AGE, PAGE)
- BioPhase 8800 (8-channel capillary electrophoresis with UV and LIF detectors; CE-SDS, cIEF)
- PA800 plus (Capillary electrophoresis with UV and PDA detectors; CE-SDS, cIEF)
- Gel Doc Go (Gel imaging)
- HIAC 9703+ Liquid Particle Counter (Sub-visible particles)
- LT-Pro HA (CCIT)
- AI-OSMOTECH (Osmolality)Zetasizer Ultra (Red) (DLS)
- BD FACSLyric (Flow cytometry)
- NucleoCounter NC-202 & NC-200 (Cell counter)
- Isoflex R (Sterility testing)
- Quantstudio 6flex (qPCR)
- QuantStudio Absolute Q (dPCR)
- ABI 3500 Genetic Analyzer (Sanger Sequencing)
- 7500 Fast (RT-PCR)
- ProFlex 2 x 96-well PCR System (PCR)
Our analytical capacities also extend to bioburden, MAT (monocyte activation testing) for non-endotoxin pyrogens, and general compendial methods such as appearance (Color and clarity, visual particles).