Process Analytical Technology

Challenge: Viral vector and plasmid production require precise analytics to ensure titer, purity, and yield—but most tools are manual and slow.

Our Solution: Maverick and ZipChip deliver rapid, orthogonal insights into vector integrity, empty/full ratios, and plasmid purity.

Challenge: Cell therapies demand rigorous characterization of identity, viability, and phenotype, often under tight timelines.

Our Solution: ZipChip enables fast assessment of key surface markers and metabolites, while REBEL XT quantifies media conditions to support optimal expansion.

Challenge: Complex upstream systems require continuous nutrient profiling and metabolite monitoring to prevent culture collapse or batch failure. Traditional sampling methods are time-consuming and disruptive.

Our Solution: REBEL XT and Maven enable real-time profiling of amino acids, glucose, lactate, and ammonia to ensure optimal feed strategies and cellular performance.

Challenge: Early-stage screening often requires multiple time-consuming methods to verify protein identity and detect degradation.

Our Solution: ZipChip and Maverick provide rapid CE or mass-based protein fingerprinting, enabling quick confirmation of expression profiles and stability markers with minimal prep.

Challenge: Understanding cellular metabolism is essential, but metabolite shifts are transient and easily missed in offline workflows.

Our Solution: With REBEL XT, real-time monitoring of nutrient consumption and byproduct accumulation drives smarter decisions on feed timing and culture viability.

Challenge: Sequence verification via traditional LC-MS peptide mapping is resource-intensive and slow.

Our Solution: ZipChip enables rapid, high-resolution peptide mapping at-line to confirm sequence integrity and detect PTMs.

Challenge: High-mass proteins and aggregates can be difficult to resolve, especially with traditional LC-MS.

Our Solution: ZipChip-MS provides high-resolution intact mass analysis in minutes with reduced sample prep and run time.

Challenge: Charge heterogeneity in early development can affect efficacy and safety, but typical offline CEX or IEF methods are low throughput.

Our Solution: ZipChip CE offers fast, high-resolution separation of charge variants to assess product consistency before scale-up.

Challenge: Manual concentration checks introduce variability and slow down release timelines.

Our Solution: FlowVPX and SoloVPE PLUS offer rapid, dilution-free quantification at every stage—from UF/DF to final fill.

Challenge: Measuring nucleic acid concentration post-encapsulation or purification is time-sensitive and prone to dilution error.

Our Solution: SoloVPE PLUS delivers accurate, real-time quantification with no dilution, supporting both development and QC.

Challenge: Assessing pDNA purity is critical for gene therapy but traditional assays are slow and reagent-heavy.

Our Solution: SoloVPE PLUS delivers fast, dilution-free A260/A280 ratio measurements for rapid purity checks.

Challenge: Surfactant degradation is a known stability issue, but often goes undetected in downstream processing.

Our Solution: In-line absorbance monitoring ensures polysorbate levels are within spec, protecting protein formulations.

Challenge: DAR is a critical quality attribute for ADCs, but offline methods are often low-throughput.

Our Solution: FlowVPX enables in-line DAR monitoring for consistency and compliance during conjugation.

Challenge: Monitoring multiple analytes simultaneously is difficult with single-channel sensors.

Our Solution: Variable pathlength technology supports spectral deconvolution and simultaneous quantification of key analytes.

Challenge: Nanoparticle-based formulations demand size and concentration validation at-line, yet most methods lack precision.

Our Solution: FlowVPX and SoloVPE PLUS provide particle-sensitive UV detection for fast confirmation of gold nanoparticle content.