Microbial Expression & Process Development
Practical manufacturing support for selected proteins and VHH / nanobody-based programs
Microbial fermentation can provide an efficient route for selected recombinant proteins, nanobody fragments, fusion constructs and targeting moieties, but development success depends on sequence design, soluble expression, fermentation control, purification strategy, endotoxin and process-related impurity control, and structured transfer into GMP-oriented manufacturing. CATUG focuses on these practical CMC execution needs rather than positioning this as a full-length monoclonal antibody platform.
Expression Feasibility
Construct-to-Expression Assessment
Support for sequence review, expression construct design, host / vector consideration, expression screening, soluble expression assessment and early manufacturability evaluation for selected recombinant proteins.
Fermentation Development
Microbial Fermentation Process Optimization
Development support can include seed train, induction strategy, fermentation parameters, harvest timing, expression level, soluble fraction, inclusion body risk and scale-up-oriented process understanding.
Nanobody / VHH
VHH and Targeting-Moiety Production Support
Process development for selected VHH / nanobody candidates and protein-based targeting moieties, including programs where compact binding domains may support tLNP or other targeted delivery designs.
Fusion & Peptide-Like Constructs
Recombinant Fusion Protein Development
Support for selected microbial-expressible fusion proteins, short-chain recombinant constructs, peptide-fusion formats and engineered protein designs requiring expression and purification optimization.
Purification & Impurity Control
Purification Strategy and Endotoxin Control
Downstream support covering lysis, clarification, chromatography, UF/DF, concentration, formulation, endotoxin reduction, HCP / HCD control and product-related impurity characterization.
Tech Transfer & CMC Readiness
GMP-Oriented Transfer Support
Support for process descriptions, batch records, analytical methods, release-related testing, comparability planning, scale-up documentation and structured transfer into GMP-oriented manufacturing.