Hands-on laboratory and process development support spanning upstream, downstream, formulation, and analytical — for biologics, proteins, and extracellular vesicles.
From early process design through scale-up and transfer, these services cover the full breadth of laboratory and development needs for biological products — executed with practitioner-grade rigour and a clear eye toward regulatory readiness.
Process-development support for biologics, proteins, extracellular vesicles and other complex biological products. Services include process design, parameter screening, recovery and yield optimization, impurity-reduction strategies, scale-up planning, process troubleshooting and technology-transfer preparation.
Multi-scale tangential flow filtration development for concentration, diafiltration and buffer exchange. Services include membrane and molecular-weight-cutoff selection, operating-parameter optimization, flux and recovery assessment, fouling evaluation, mass balance, scale-up recommendations and integration with downstream purification.
Filtration studies supporting clarification, bioburden reduction, sterile-filtration development and process-scale selection. Services include filter screening, throughput and capacity evaluation, pressure and flux assessment, product-recovery testing, adsorption-risk evaluation and prefilter/final-filter strategy development.
Small-scale protein purification and FPLC chromatography development using affinity, ion-exchange, size-exclusion, hydrophobic-interaction and multimodal approaches. Services include resin screening, capture and polishing development, impurity clearance, recovery assessment, fraction analysis and scale-up recommendations.
Purification and concentration development for mammalian- and microbial-derived extracellular vesicles. Services may include centrifugation, TFF, filtration and chromatography-based workflows, with assessment of particle recovery, size distribution, aggregation, protein and nucleic-acid impurities, endotoxin and formulation stability.
Formulation and buffer-development support for proteins, biologics and extracellular vesicles. Services include buffer preparation, pH and osmolality optimization, excipient screening, concentration studies, freeze–thaw assessment, hold-time evaluation, compatibility studies and preparation of materials for stability testing.
Lyophilization development for proteins, biologics, extracellular vesicles and research-use materials. Services include formulation screening, cryoprotectant and lyoprotectant selection, freeze-drying cycle development, reconstitution assessment, cake-quality evaluation and pre-/post-lyophilization comparability testing.
Analytical characterization of proteins and biologics using SDS-PAGE, Western blotting, thermal-shift assays and differential scanning calorimetry. Studies can support identity assessment, purity and degradation evaluation, thermal stability, formulation screening, process comparability and troubleshooting.
Zetasizer-based characterization of particle size, polydispersity and zeta potential for extracellular vesicles, nanoparticles, protein formulations and other dispersed systems. Testing can support formulation selection, aggregation assessment, process comparison, freeze–thaw studies and stability evaluation.
qPCR-based analytical support for process development and biological-product characterization. Applications may include target detection, relative quantification, residual nucleic-acid assessment, process-comparison studies and evaluation of nucleic-acid recovery across purification steps.
Endotoxin testing and method-development support for biologics, proteins, extracellular vesicles, buffers and process samples. Services include sample suitability, dilution and interference evaluation, spike-recovery studies, process monitoring and investigation of formulation-related inhibition or enhancement.
Cell-culture monitoring using Cedex metabolite analysis and NucleoCounter-based cell counting. Testing can include viable cell concentration, viability and key metabolite measurements to support culture monitoring, harvest-time decisions, process comparison, troubleshooting and scale-up studies.
Compendial and general analytical testing support for development-stage biological products and formulations. Available measurements include pH, osmolality, appearance and other applicable physicochemical tests. Services can support method feasibility, formulation comparison, stability studies and analytical testing-plan development.
Technical support for process changes, scale-up and transfer between laboratories, manufacturers or CDMOs. Services include process-gap assessment, equipment and parameter comparison, analytical comparability planning, risk assessment, protocol development, data review and preparation of practical transfer documentation.
Whether you need a single analytical method or end-to-end downstream process development, reach out for a no-obligation scoping conversation.