Microbial Recombinant Proteins-Asymchem Labs.

One Stop Services For Microbial Recombinant Protein Drugs

One stop microbial recombinant protein drug process development services from early clinical stage to commercial production, providing clients with high quality full process services from strain development, cell bank establishment to manufacturing process development, GMP manufacturing for clinical / commercial products, and regulatory filing / approval. We have provided R&D and manufacturing services for recombinant protein drugs to many well known pharmaceutical company clients worldwide.

One stop service capabilities

Strain development

Cell bank establishment

Fermentation process development

Separation and purification process development

IND filing and clinical studies at all stages

Process characterization & stability studies

Process Performance Qualification (PPQ)

BLA & DMF filing

Diverse product portfolio: microbial recombinant protein drugs including enzymes, fusion proteins, nanobodies, peptides, growth factors, cytokines, etc.

Gene synthesis & expression vector construction

High throughput protein expression screening

Various high efficiency expression systems: E. coli, Saccharomyces cerevisiae, Pichia pastoris, Bacillus subtilis

GMP cell bank establishment

Strain preservation

Group level comprehensive quality control and quality assurance system

Process validation

BLA filing

DMF filing

Fermentation medium design and screening

High density fermentation process development and scale up

Realize shake flask to large scale production in a short period of time

GMP production line with complete equipment chain of 5L, 50L, 500L, 5,000L

Purification process design and resin screening

Separation & purification process development

Large scale, GMP compliant purification process complete equipment chain

Efficient control strategies for HCP/HCD and endotoxin

Sample production for clinical and preclinical studies

Analytical method development / transfer / prevalidation

Physicochemical characterization

Stability studies

Product release

GMP Drug Substance Manufacturing Platform

We provide high quality recombinant protein drug microbial fermentation services at scales from 5L, 50L, 500L to 5,000L.

We have a recombinant protein drug bulk drug production line complying with global GMP requirements, capable of meeting the manufacturing needs of various recombinant protein drugs including enzymes, recombinant proteins, peptides and more at all stages, with extensive CMC development, clinical manufacturing and service capabilities.

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