Analytics

At NorthX Biologics we have a proven track record of developing early-stage processes and analytics into a suitable manufacturing package for clinical applications and on to commercialization.

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

NorthX Biologics is committed to delivering precise and reliable testing solutions to support the development and manufacturing of advanced biopharmaceutical products.

Analytical Development

Our teams for Analytical Development and Quality Control (QC) are well integrated to ensure a swift and seamless transfer of developed methods into QC for phase-appropriate qualification, adhering to guideline ICH Q14 Analytical procedure development.

We offer flexibility in client involvement during method development and optimization. Whether you prefer to be hands-on at our sites or want us to take full responsibility for the transfer, development, qualification, or outsourcing to approved vendors, we are here to accommodate your needs. Our team is dedicated to meeting your specific requirements and ensuring the highest quality standards.

We also provide verification of compendial methods and can conduct screenings or pre-tests of generic analytical methods, ensuring robust and reliable results for your biopharmaceutical products.

Quality Control

At NorthX Biologics, we provide analytical method validation and verification for biologics, spanning from pre-clinical to commercial phase.

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)
  • Transfer of qualified methods
  • Verification of compendial methods
  • Qualification/validation of product-specific methods
  • Release analytics of drug substance
  • Release analytics of drug product

Our services also expand to:

  • In-house monitoring of manufacturing environment (e.g. particles, microbial monitoring, water, steam)
  • Sampling and testing of raw materials
  • IPC validation and testing

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. This commitment guarantees the highest standards of quality and compliance in our processes.

  • Real time and accelerated stability testing
  • Long-term stability studies
  • Forced degradation studies
  • Advanced analytical methods supporting stability testing
  • Available GMP storage conditions:
  • ≤-135 °C
  • -80 °C ± 10 °C
  • -70 °C ± 10 °C
  • -20 °C ± 5 °C
  • +5 °C ± 3 °C
  • +25°C ± 2 °C / 60% RH ± 5 %
  • +40 °C ± 2 °C / 75% RH ± 5 %
  • Higher temperature conditions without humidity control
  • We offer full qualification and characterization of reference standards

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 etc.)
  • 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 etc.)
  • PA800 plus (Capillary electrophoresis with UV, PDA and LIF detectors; CE-SDS, cIEF etc.)
  • Gel Doc Go Imagine System (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).

Let’s journey together

NorthX Biologics is dedicated to the journey of complex biologics. Let us know how we can help move your product forward.