Dx/Pre-GMP Biomanufacturing

Kemp Proteins offers multi-liter, low-endotoxin protein manufacturing services that ensure a reliable supply of superior-quality material for preclinical research and diagnostics development. Applying more than 30 years of experience manufacturing well-characterized proteins in multi-expression systems, our seasoned team develops customized processes that are reproducible, fully scalable, and facilitate translation to GMP production and/or production of large product yields.

We have helped many biotherapeutic and diagnostic companies develop and scale their candidate targets. Our support and documentation has enabled them to easily transfer our processes through to GMP and IVD production.

Our Service Offerings Include:

A wide range of mammalian/BacMam, insect, and E. coli protein expression platforms available for production
Scalable equipment, technologies, and robust protocols that enable clients to take their customized processes forward independently
Multiple bioreactors

Use our quick quote form to request a quote.

Not sure which cell line to use? Get in touch.

Biomanufacturing / CDMO Service Information:

Cell Culture Capabilities:
Up to 100 L and beyond, depending on project

Quality Control Testing:
Manufactured in a United States-based facility with qualified personnel and calibrated/maintained instrumentation. Head of Quality will assist customers with process documentation transfer for potential GMP manufacture, if required.

Fully executed COA includes:
Purity ≥ 90%
Aggregation ≤ 5%
Endotoxin levels ≤ 2 EU/mg
Functionality testing by ELISA
Screen for adventitious agents (Impact Assay)

End Uses:

Therapeutic:
Biological Proof of Principle (POP) Studies
Toxicology Studies
Pharmcokinetic (PK) Studies Studies
Pharmacodynamic (PD) Studies
Animal Efficacy Studies
In Vitro & Cell-Based Assays

Diagnostic:
Enzyme Immunosorbant Assay (EIA)
Lateral Flow Assay or Immunoassay
ELISA Assay
Immunohistochemistry (IHC)
Immunoprecipitation (IP)
Western Blot (WB)
Antibody Pairing
IF/Flow cytometry
Anti-Idiotypic (Anti-ID; Anti-Idiotype) Antibody
Anti-Drug Antibody (ADA)
Phosphorylation-Specific Antibody
G protein-coupled receptors (GPCRs)

Other:
Protein Antigen Production
Antigen-Specific Reagent (ASR)
Laboratory-Developed Test (LDT)
Research Use Only Reagent (RUO)

Workflow & Timeline: Dx/Pre-GMP Biomanufacturing

Kemp Proteins Dx/Pre-GMP Biomanufacturing Timeline