Microbial Production of APIs

Active pharmaceutical ingredients (APIs) are the biological/synthetic active constituent of pharmaceuticals. Microorganisms conduct fermentation and create secondary metabolites. Adjustments in growth environments can be used to make these organisms covert economical carbon sources (starch, sucrose, glucose, etc.) and nitrogen sources (soybean flour, cotton-seed flour, peptone, etc.) into highly useful key intermediates or microbial APIs. The market demand for microbial APIs is attributed to characteristics such as non-toxicity, ease of availability, and high specificity. Biotransformations with microorganisms in chemical production pathways expand the field of biotechnological production of pharmaceuticals. The increasing knowledge in the regulation of the biosynthesis processes, the growing experience in the use of microorganisms as biocatalysts and source of valuable enzymes and the development of new economical technical procedures raised the number and volume of drugs prepared by microbial biosynthesis and biotransformation.

Figure 1 Biochemical conversion of biomass into valuable APIs

Microbial fermentation and recombinant DNA technology have been widely used in the production of APIs and intermediates for various medications. The modern method of the genetic engineering supported by the chemical DNA-synthesis enables the preparation of important proteohormones and physiologically active peptides in microorganisms. Biotechnological productions of vitamins, steroids, alkaloids, amino acids, organic acids, nucleosides and nucleotides in microorganisms will combine with new developments in the preparation of blood factors, enzyme inhibitors, hormones and physiologically active peptides and the possible future use of monoclonal antibodies.

Microbial APIs Examples

• Intermediates for Synthetic Drugs

Microorganisms can be genetically engineered to produce specific intermediates used in the synthesis of various synthetic drugs. Microbial hosts, such as bacteria or yeast, are modified to express enzymes or pathways that enable the production of specific chemical intermediates. These intermediates can then be further processed and chemically transformed into the desired APIs.

• Nucleosides and Nucletides

Nucleosides and nucleotides are organic compounds that play crucial roles in various biological processes and cellular functions, including DNA and RNA synthesis, energy metabolism, and signaling pathways. They can be used as APIs for medicinal purposes.

• Hormones

Bacteria, yeast, or other microorganisms are engineered to express human or animal genes encoding proteins or hormones of interest. These microorganisms are then grown in large-scale fermenters to produce the desired hormone, which can be purified and used as an API.

Custom options for Microbial APIs Production

Microbial production of pharmaceutical APIs offers advantages such as scalability, cost-effectiveness, and the ability to perform complex biochemical reactions. It enables the production of APIs in large quantities, ensuring a stable supply for therapeutic purposes. Furthermore, microbial systems can be engineered to optimize production yields, improve purity, and introduce modifications to the synthesized compounds.

Creative Biogene reserves strong microbial fermentation capabilities for APIs. Our extensive experience and advanced fermentation technique support the development of pharmaceutical compounds. Our manufacturing services can be individually tailored to fit each project. We provide small-scale test, pilot and cGMP fermentation, and downstream purification, ultimately reaching customer's goal in the most efficient way.

If you are interested in our services, please contact us for more details.