Downstream Process Development Services

Creative Biolabs is a global company that focuses on live biotherapeutics drug discovery and development. We have built a team of experienced scientists with facilities and processes designed specifically to provide the best strategy and protocols customized to downstream process development for live biotherapeutics products. We are proud to partner with our clients on the journey of developing the most appropriate strategy that will offer the most meaningful data for your research.

Introduction to Live Biotherapeutics Products

Live biotherapeutic products are a group of biological products that can be used for preventing or treating various human and animal diseases in the clinic. In general, a live biotherapeutic product is often composed of a certain live microorganism, and the interaction between the hosts and microbes provides a unique opportunity to treat diseases by mediating the structure and function of the microbial community. Nowadays, many modified bacterial strains have been generated for the development of live biotherapeutics for human diseases. Meanwhile, a panel of synthetic biology tools has been broadly used for assessing the safety, reliability, specificity, as well as manufacturability at scale.

Fig.1 Strategy for the development of engineered live bacterial therapeutic clinical candidates. (Charbonneau, 2020)

The Downstream Process Development for Live Biotherapeutics Products

To obtain approval for clinical use, the companies for live biotherapeutics product production, processing, and packaging should be meet all requirements of existing good Manufacturing Practices (cGMP). In particular, a wide array of aspects, such as the genome sequence of engineered bacterial therapeutics, the antibiotic resistance cassette, and the biocontainment property, have been determined before clinical use. Moreover, recent studies have demonstrated that the downstream process development is essential to biopharmaceuticals, especially for live biotherapeutics products.

Fig.2 The cGMP manufacturing process of live biotherapeutics products. (Lebrec, 2010)

As a professional expert in the field of live biotherapeutics product discovery and downstream process analysis, Creative Biolabs offers a wide collection of custom services for our clients to recycle and purify live biotherapeutics products, from natural sources to diversified biologic drug pipelines. For instance, we are capable of optimizing your downstream purification process with various reliable tools for cell isolation, expansion, chromatography, mixing technology, and process monitoring. With years of operational experience, we can provide innovative solutions designed to give you more R&D advantages.

Custom Services of Downstream Process Development 

As your needs evolve, so do we. Up to now, a diverse range of development solutions, buffers, separation techniques, ready-to-use systems, advanced technologies have been established for improving product yields, reducing product costs, as well as maintaining high product purity. Below is the brief standard procedure for downstream process development services of live biotherapeutics products in Creative Biolabs.

• Initial Recovery
• Purification
• Concentration
• Polishing
• Formulation

Methods for Downstream Process Development

At present, the main obstacle to the cGMP manufacturing of live biotherapeutics products is that conventional methods are not sufficient to obtain the high batch output and purity in downstream bioprocessing. As a consequence, Creative Biolabs’ bioinformatics analysis team has studied the downstream scalability techniques and developed efficient protocols for optimal efficiency from end to end.

Classical chromatography has been considered as a perfect tool for live biotherapeutics product purification in many industrial applications and has become a popular choice due to its high throughput capacity. Our chromatography technology is developed by the combination of related technologies of various disciplines. Currently, our innovative chromatography analysis system can be divided into four groups: liquid chromatography (LC), gas chromatography (GC), thin-layer chromatography, and paper chromatography.

Creative Biolabs has developed a novel live biotherapeutics product discovery platform for designing, evaluating, as well as optimizing the downstream process to boost the safety and efficacy of you live biotherapeutics product candidates. Our scientists specialized in live biotherapeutics products cGMP manufacturing will remove the obstacles of your projects and bring breakthroughs to affect the future of live biotherapeutics development. If you are interested in our services, please feel free to contact us or send us an inquiry.

References

1. Charbonneau, M. R., et al. Developing a new class of engineered live bacterial therapeutics to treat human diseases. Nature Communications. 2020, 11(1): 1-11.
2. Lebrec, H., et al. Overview of the nonclinical quality and toxicology testing for recombinant biopharmaceuticals produced in mammalian cells. Journal of Applied Toxicology. 2010, 30(5): 387-396.

For Research Use Only. Not intended for use in food manufacturing or medical procedures (diagnostics or therapeutics). Do Not Use in Humans.