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April 6, 2023 | OncoBone article

CRDMO services with Professional Microbial Expression System

OncoBone has partnered with a global leading CRDMO service provider to complement its drug development service offering. Below you can find more information about the service, and you can request additional information by reaching

What is a CRDMO?

CRDMO stands for Contract Research Development and Manufacturing Organization. The partner CRDMO of OncoBone has special expertise in microbial expression systems and the work for example with recombinant proteins/polypeptides, nanobodies, gene therapies, nucleic acid drugs and novel recombinant vaccines. The scope of their business covers one-stop chemistry, manufacturing and controls (CMC) services throughout the entire drug lifecycle, including for example engineering bacteria construction, strain bank establishment, lab scale process development and optimization, pilot process scale-up and production, clinical sample preparation, quality specification establishment, analytical method development and validation, compliant production (GMP), quality management system establishment and registration application.

Figure 1: Overview of CRDMO service covering.

Scope of the CRDMO offering

The partner CRDMO utilizes a Professional Microbial Expression System to manufacture products in the following categories:

  • Recombinant proteins and polypeptides
    • Services from strain bank construction, process and analytical method development and cGMP production to aseptic filling of drug products
    • Supporting recombinant polypeptides/proteins, recombinant antibodies (antibody fragments) and recombinant vaccines (VLP) etc.
  • Nanobodies
    • E.coli prokaryotic expression, eukaryotic expression and mammalian cell expression systems
    • Monovalent, bivalent and trivalent nanobodies
  • Polypeptide nucleic acid drugs
    • Process development from sequence design and optimization, gene synthesis, in vitro transcription, purification and mRNA quality control
    • Pre-made/customized RNA products
    • Supporting mRNA, CircRNA, etc.
  • Cell and gene therapy polypeptides
    • Different levels of plasmids such as non-GMP, GMP-like and GMP according to client’s requirements, to meet the needs of different phases of research, IND registration and application, clinical research and commercial production

Drug substance production capabilities

Through the partnership OncoBone can provide our clients services for preclinical, clinical and marketed drug production in a one-stop shop manner. There are five production lines of drug substance designed based on quality by design (QbD) and in compliance of GMP requirements of FDA and EMA, which can provide bioreactors at various sizes of 50-100 L, 200 L, 500 L, 1,000 L and 2,000 L to support production needs of our clients at different stages of development.

Relying on international advanced production equipment, flexible production line configuration and high standard quality systems, the new drug development process of the clients can be efficiently promoted.

Service highlights include:

  • Industrial scale guarantee
    • Production services of drug substances at a scale of 50-100 L, 200 L, 500 L, 1,000 L, and 2,000 L to meet the needs of different projects
  • Rich technology transfer experience
    • Comprehensive and perfect technology transfer process and risk control system
  • Compliance assurance
    • Well-established quality management system in compliance with the requirements of FDA and EMA, and an experienced quality management team

Quality Control System

High quality of the CRDMO service is ensured with a high GMP quality management system, providing clients continuous and stable quality services through close co-operation between the quality control (QC), production and quality assurance (QA) teams in testing raw materials and excipients, intermediate process controls, stability studies and product release testing of biological drug products. The certified QC system is in compliance with regulatory requirements throughout all phases of QC testing.

Service features include:

  • Equipped with advanced quality analysis testing instruments
  • The QC team has undergone strict GMP training and guidance and is familiar with newly revised GMP requirements
  • Skilled in physical, chemical, biological and microbiological QC testing methods
  • Rich experience in project execution
  • In addition to current scopes, the testing capabilities continue to be expanded

Overview of globalized registration and application services

High-quality, efficient and accurate registration support is provided by an extensive drug registration and application team, including domestic and international IND/BLA application services. The comprehensive registration and application services include CMC consulting services, guidance on registration and application strategy, assistance in completing writing and submission of CMC-related CTD documents, assistance in communication with official agencies, guidance on site verification for development and research, organization of drug registration regulations training and conference guidance, etc.

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