Solutions

Biologics testing solutions are specifically designed processes that enable critical usage in drug development and production. The usage of large molecules in these processes is carefully undertaken because of the sensitivity. Safety and efficacy are paramount when testing is concerned. Hence, we consider continuous monitoring during the manufacturing process which adheres to stringent regulatory requirements.

Stellixir Biotech has a well-equipped lab led by a team of experts in Biologics testing solutions. Appropriate method validation and resources used for drug development testing are strategized by our experts in each phase to meet the demand.

Services Offered

Contamination & Impurity Testing

Drug development relies on the most efficient and reliable contamination testing methods that comply with regulatory guidelines. We rely on bulk testing for both clinical and marketed batched. The contamination removal will ensure that all the impurities and residue are removed, in compliance with the regulatory measures. Hence, we offer various contamination testing approaches such as microbiology, mycoplasma, endotoxin, next-generation sequencing, and product-related impurity, including HPLC-MS and ELISA.

Tests Offered by Stellixir

• Microbiology testing
• Mycoplasma testing
• Sterility testing
• Pyrogenicity, Endotoxin, and Monocyte activation testing
• Viral safety testing
• Next-Generation Sequencing
• Host cell protein assays
• Process and product related impurities – HPLC-ELSD, HPLC-CAD, HPLC-MS, ELISA
• Residual DNA testing

Bioactivity & Potency Testing

When looking for a method to check the mechanism of action of the used product, you will have to rely on potency assays that must be reliable and standardized to meet the criteria. These tests and assays are the backbone for the product development and manufacturing. Stellixir Biotech has a team of experts who work on establishing and validating routine bioassays that are up to GMP standards. We provide the full range of potency testing services.

The Services Include:

• Method development, transfer, and optimization
• Phase-appropriate method validation
• Stability storage and testing
• Accelerated stress studies
• Comparability testing between innovator and biosimilar biological products

Lot & Final Drug Product Release Testing

Stellixir Biotech release testing services maintain good manufacturing practices. Our expert team works in tandem with the operational staff and meet the client’s manufacturing schedules. We perform full specification lot release testing as per client requirements. The turnaround period usually varies and may consume more time than anticipated for the product and release of the drug. But we assure of reliability and quality from our side. For efficient testing we perform SDS-PAGE, Western Blot, potency testing by in-vitro cell-based assay, protein characterization by HPLC-MS, Western blot, ELISA, and Impurity analysis by different chromatographic methods.

Stellixir lot testing program consists of

• Identity:
  • SDS-PAGE with western blot or CE-SDS
  • Isoform analysis (IEF, C-IEF)
• Potency
  • Cell-based potency assays
  • In vivo potency
  • Protein characterization
  • Binding assays
• Purity and Impurities:
  • Residual DNA/host cell protein
  • Size-exclusion HPLC of proteins
  • Cation-exchange HPLC of proteins
  • Reverse-phase (RP) HPLC of proteins
  • CE-SDS, C-IEF
• Physiochemical Properties:
  • pH determination
  • Osmolality determination
  • Presentation attributes
• Visual Assessment
  • Determination of volume in syringes and vials
  • Determination of excipient levelsn
• Microbiology
  • Sterility testing
  • Microbiology assays
  • LAL/monocyte activation test, in vivo pyrogenicity
  • General safety/abnormal toxicity

Protein Characterization

During drug development, a phase-appropriate validation and sample analysis involving protein characterization studies are mandatory which follows GMP. Quality infrastructure and scientific experts from our side ensure protein characterization services adhere to regulatory guidelines. At Stellixir Biotech, we have a broad range of support protein characterization that involves recombinant protein and peptide therapeutics such as HPLC-MS, ELISA, Western blot, Fluorescence spectroscopy etc.

Stellixir offers the following assays

Ultra-high-pressure liquid chromatography (UHPLC)

SEC, IEX, RP, and HILIC methods, with detection using UV, PDA, fluorescence, CAD, ELSD, MALS, and MS

Mass Spectrometry (MS)

High-resolution accurate mass (HRAM) analysis on QTOF and Orbitrap platforms to profile and characterize intact proteins/subunits, peptides, and post-translational modifications, released N- and O-linked glycans, and Host Cell Proteins (HCP) at high sensitivity

• Electrophoretic separation by mass or charge
• Western blot
• Binding assays, including ELISA and SPR
• Biophysical methodologies
• AUC, CD, DCS, FTIR, and MALS

A diverse array of in-house platform and compendial methods along with product-specific in vitro potency assays supporting stability and product release.

Cell Line Characterization

Development of drugs requires certainty from cell banks because they need to contain contaminant-free cell lines. Our experts will look into the documentation of the source of the cell line, development history along with the biological properties of the same. Stellixir Biotech ensures all the current regulations are adhered to when performing with master and working cell banks using the recommended testing procedures such as testing mycoplasma contamination, Cell line identity by DNA sequencing, and virus testing by TEM.

Stellixir assays on cell line characterization includes

• We find out the origin and history of the cell line by checking its cellular morphology and growth characteristics
• Cellular identity
• Purity of the cell lines (i.e., absence of contaminating cells, microbial contaminations, and contaminations by adventitious viruses)
• Tumorigenicity and oncogenicity
• Stability