Fermentation for APIs

BOC Sciences reserve strong microbial fermentation capabilities for APIs. We focus on the production and manufacturing of biological and chemical APIs via the fermentation technique. We provide pilot-to-commercial microbial fermentation capabilities, offering full support throughout the products’ life cycle. Our extensive experience and advanced fermentation technique support the development of pharmaceutical APIs.

Introduction

In the pharmaceutical industry, fermentation production of active pharmaceutical ingredients (APIs) commonly includes small molecules such as peptides, oligonucleotides, low molecular weight organic molecules, and biological macromolecules such as protein, DNA, RNA, polysaccharides, lipids and their assemblies. Microbial fermentation could be considered as the preferred solution for the production of APIs. In comparison to the synthetic chemical method, fermentation processes support the production of unique chemical molecules dependent on microorganism systems, such as antibiotics and other secondary metabolites. In addition, organic molecules are often structurally complex, including chiral centers, large stereocyclic rings, or heterocyclic systems that require multi-step synthesis to obtain. In contrast, fermentation is often a way to convert readily available raw materials such as sugars, or other inexpensive substrates into high-value products with high yields that ensure the commercial viability of high-quality products. Thus, microbial fermentation provides a more economical method for chemical APIs.

Application of Fermentation for APIs

Although microbial fermentation is not a new technology, it supports pharmaceutical companies by providing an optimal economic way to shorten the production period. Moreover, safer and more effective medicines are provided when fermentation technique is combined with current molecular biology technologies or genetic engineering tools. We believe that the continuous growth of molecular biology and synthetic biology technologies will significantly impact novel biosynthetic pathways. Microbial fermentation methods are not only used in the pharmaceutical field but also food, agriculture, biocatalytic enzymes and other fields.

High Potent APIs

BOC Sciences has chemical and fermentation processing suites equipped to handle potent substances. We have facilitated successful delivery in more than 20 HPAPI (Highly potent active pharmaceutical ingredient) projects over the past years and it’s an area where we plan to continue expanding our capabilities.

Our Advantages

Considerable experience in traditional strain breeding and fermentation production.
One-stop fermentation, analysis and purification services for targeted small molecules.
Advanced fermentation process and modern fermentation facilities.
Expertise in combining synthetic chemistry with fermentation and successfully developed many chiral APIs and intermediates.
Extensive strain development technologies, include genetic engineering directed breeding, high-throughput screening technique, protoplast fusion, space breeding technology, strains preservation and identification.
Comprehensive analytical capabilities for molecules characterization.
Complete strain expression systems cover bacterial systems and eukaryotic systems.
Large-scale fermentation capability and the downstream process development.
Cost-effective and high-quality products.

Our Methods

Based on the synthetic biology and synthetic chemistry methods, we offer one-stop fermentation services for various APIs.

Strain development and improvement

Interspecific protoplast fusion: Recombination of genetic information from rather closely related producer strains
Gene cloning: Genes may be transferred between unrelated strains which are producers of known substances
Heterologous gene expression, adaptive laboratory evolution, random mutagenesis, site-directed mutagenesis and more.

High-throughput screening and analytical technologies

Agar plate-based screening
Fluorescence-activated cell sorting
Liquid chromatography-mass spectrometry
Other characterization methods: GC-MS, NMR, XRD, etc.

Fermentation process optimization

Process characterization
Stability development
Recovery and purification of fermentation products, etc.

Project Workflow

Customer advisory
Project discussion, fermentation formulation (customers can provide fermentation strains)
Strain development and improvement
Lab-scale fermentation and scale-up fermentation
Targeted molecules extraction and purification
Product delivery