KBI Biopharma

A premium cell line development suite of tools and technologies that overcomes common expression bottlenecks and goes from transfection to a fully-characterized research cell bank in as little as 11 weeks.

A transformative, chemically-defined, and animal origin-free basal medium developed in collaboration with JSR Life Sciences to enhance performance of CHO cell lines.

Development and manufacturing services for microbial-based biopharmaceuticals utilizing quality-by-design (QbD) principles, comprehensive analytical characterization, and cGMP manufacturing facilities.

Comprehensive ICH stability conditions and cGMP test methods for evaluating the identity, strength, purity, potency, and safety properties of drug substances and drug products.

Comprehensive microbial expression and manufacturing services utilizing an early optimization workflow to ensure manufacturing success from microfermentation to large working volumes.

Biopharmaceutical release and stability testing services supporting clinical manufacturing.

An exceptionally clean, highly-efficient, proprietary E. coli producer cell line engineered with an optimal genotype associated with reduced translational and post-translational modifications, excess genes, virulent genes, and destabilizing genes.

Mammalian-based expression cGMP biologics manufacturing services for clinical supply.

Clinical-stage microbial development, manufacturing, and commercialization services for therapeutic proteins and enzymes using E. coli-based expression systems.

Supporting mammalian-based and microbial-based expression systems.

Integrated fermentation and purification development for optimized upstream processes, including soluble protein expression, inclusion body expression, and production of monoclonal antibodies and complex glycoproteins.

Comprehensive cell culture process development services covering the full development cycle from early-stage discovery to cGMP manufacturing and process characterization.

GMP Drug Substance Manufacturing for FIH and Clinical Resupply Programs utilizing single-use technology and robust process segregation.

Mammalian cell culture manufacturing capabilities for commercial supply of biotherapeutics.

Vertically-integrated development and manufacturing platform for bispecific antibodies from cell line development through to cGMP commercial manufacturing.

Phase-specific lifecycle analytical characterization services for antibodies, enzymes, cytokines, and other unique proteins.

Monoclonality assessment reporting on the proprietary KBI SURE CHO-M Cell Line, utilizing fixed rare single nucleotide polymorphisms to assess statistical relevance of potential non-clonal populations.

Comprehensive process development services covering the full development cycle from early discovery to scaled-down validation studies.

Proprietary plasmids engineered to pair with PUREcoli for optimal protein expression.

Proprietary media designed to support PUREcoli and PUREplasmids across various screening packages.

Comprehensive analytical services and expertise for assessing the amount, type, and size of aggregates in biopharmaceuticals, proteins, peptides, nucleic acids, and other macromolecules.

Advanced Mass Spectrometry Analysis and structural characterization services for protein characterization provided by KBI Biopharma.

Comprehensive services at every phase of the project cycle.

Expert purification process development services for biotherapeutics, leveraging deep scientific knowledge and phase-specific lifecycle analytics.

Circular dichroism spectroscopy services for characterizing the higher order structure and thermal stability of proteins and DNA, provided by Alliance Protein Laboratories.

Purification process development for a wide range of biotherapeutics including monoclonal antibodies and enzymes.

Rapid, robust genomic characterization services to assess the monoclonality of research cell banks and master cell banks for IND filing.

Precise and powerful analytical services for studying the size and shape of macromolecules in solution, protein aggregation, native state stoichiometry, and higher order structure comparability.

A centralized digital hub for managing analytical testing needs from quote requests to sample submission, shipment tracking, and data report access.

Late-stage process characterization and scale-down validation studies designed to support late-stage process development, commercialization, and regulatory licensure applications for biologics.

Developing optimized formulations using a data-driven approach.