Advanced Process & Product Development

Our Services

A comprehensive, modular suite of bioprocess capabilities — tailored precisely to your protein, your timeline, and your program goals.

01

Expression from Diverse Hosts

Microbial & mammalian expression system optimization

We eliminate development bottlenecks by selecting and optimizing the ideal expression system for your specific protein. Our expertise spans microbial (E. coli, yeast) and eukaryotic (mammalian cell lines) hosts, ensuring maximum yield and correct post-translational modifications for functional activity.

Key Capabilities

  • E. coli & yeast expression systems
  • Mammalian cell line development (CHO, HEK)
  • Codon optimization & vector design
  • Post-translational modification verification
  • Scalable expression protocols
02

Extensive Purification Expertise

Multi-step chromatographic protocols for therapeutic-grade purity

Achieving therapeutic-grade purity is our specialty. Leveraging advanced chromatographic techniques — including Affinity, Ion Exchange, Hydrophobic Interaction, and Size Exclusion Chromatography — we develop tailored, multi-step purification protocols that deliver exceptional purity while maximizing recovery, often exceeding industry standards.

Key Capabilities

  • Affinity chromatography (Protein A/G, His-tag)
  • Ion Exchange & Hydrophobic Interaction
  • Size Exclusion Chromatography (SEC)
  • Multi-step protocol design
  • Yield maximization & impurity removal
03
Protein Refolding

Protein Refolding Mastery

Rescuing functional protein from inclusion bodies

For challenging proteins expressed in inclusion bodies, our scientists possess deep expertise in optimizing protein refolding conditions. We employ proprietary methodologies to rescue functionally active protein from insoluble aggregates, significantly increasing product yield and viability.

Key Capabilities

  • Inclusion body solubilization
  • Refolding buffer & condition screening
  • Proprietary refolding methodologies
  • Activity verification post-refolding
  • Scale-up from bench to pilot
04

Protein Formulation

Rational development for long-term stability & patient delivery

We ensure the long-term viability of your therapeutic through rational formulation development. This involves extensive excipient screening, stress testing (thermal, chemical), and buffer optimization to identify the optimal liquid or frozen dosage form. Our goal is to maximize shelf-life, maintain functional activity, and ensure patient-friendly delivery, mitigating aggregation and degradation risks for successful clinical trials.

Key Capabilities

  • Excipient screening & optimization
  • Thermal & chemical stress testing
  • Liquid and frozen formulations
  • Aggregation & degradation profiling
  • Short and long term shelf stability studies
05

Engineering & Mutagenesis

Enhancing therapeutic performance and manufacturability

Enhance your therapeutic's performance and manufacturability. Our capabilities in site-directed mutagenesis and protein engineering are utilized to improve stability, increase activity, optimize half-life, reduce immunogenicity, or facilitate purification — giving your candidate a competitive edge.

Key Capabilities

  • Site-directed mutagenesis
  • Stability & half-life optimization
  • Immunogenicity reduction strategies
  • Purification tag engineering
  • Fc-fusion & conjugation design
06

Validated Functional Assays

Critical potency & activity data for regulatory submissions

We develop and implement robust, qualified biological and binding assays (ELISA, SPR, cell-based assays) to measure product activity and potency, providing the critical data necessary to demonstrate efficacy and support regulatory submissions.

Key Capabilities

  • Protein labeling for assays
  • ELISA development & qualification
  • Surface Plasmon Resonance (SPR)
  • Cell-based potency assays
  • Binding kinetics determination
07

State-of-the-Art Analytical Tools

Rigorous characterization at every development stage

Quality is ensured through rigorous characterization. We utilize a comprehensive suite of analytical technologies to confirm structural integrity, homogeneity, identity, and purity at every stage of development — providing the complete data trail required for regulatory confidence.

Key Capabilities

  • SEC-HPLC, RP-HPLC and DSF
  • Mass spectrometry (intact & peptide mapping)
  • Absorbance & fluorescence spectroscopy
  • SDS-PAGE, Western blot & cIEF
  • Full characterization data packages

The Development Pipeline

Discovery

Protein assessment & feasibility

Expression Optimization

Host selection & yield maximization

Purification & Characterization

Therapeutic-grade purity

Formulation & Stability

Shelf-life & dosage optimization

BLA CMC Package

CMC documentation & tech transfer

Need a Custom Development Program?

Our modular approach means you can engage us for a single specialized service or a complete end-to-end program.

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