Our promise to you:
Guaranteed product quality, expert customer support.
24x7 CUSTOMER SERVICE
CONTACT US TO ORDER
Market demand has driven the development of various biologics and production processes. In the mass production of biologics, the development of upstream and downstream processes requires significant investment of human and material resources, which is directly related to productivity and product quality. Creative Biogene has extensive experience in the development of manufacturing processes for a variety of biologics, such as recombinant proteins, antibodies, viral vectors or other products of biological origin. Our talented and highly trained scientists are committed to using our advanced technology to provide robust, scalable and GMP-compliant manufacturing processes to deliver high-quality, customized solutions for the production of complex biologics.
Manufacturing process development for biologics includes activities that help you create a series of steps to produce biomolecules - monoclonal antibodies (mAb), recombinant proteins, viral vectors or other products from biological sources. Bioprocess development is typically divided into upstream process development and downstream process development. These activities must be combined with proper analysis so that you can accurately measure the critical quality attributes (CQA) of the products you identify as you develop and refine your processes. Process development activities will vary depending on the type of biomolecule you have and the stage of the drug development process you are in - preclinical, early clinical (Phase I/II) or late clinical (Phase III/IV). Regulatory requirements will guide many of these activities. In addition, your process must be cost effective and reproducible.
Fig. 1 Schematic manufacturing process of monoclonal antibodies from cell culture. (Gronemeyer, et al., 2014)
Biologics manufacturing process development is typically divided into upstream process development and downstream process development. Process development must balance product quality with process performance, so these activities are often time-consuming and cumbersome. Creative Biogene can quickly create cost-effective manufacturing-scale processes to help customers address any challenges encountered during biologics production and development.
Upstream process development includes workflows from cell line development to bioreactor processes developed prior to the harvesting and purification steps. Creative Biogene can provide expert solutions in every step of host cell line selection and optimization of expression conditions for high-yield biologics.
Specific activities for upstream development include:
Downstream Process Development
The downstream process refers to the recovery and purification of the target molecule after the upstream process. It includes harvesting, purification and virus removal steps. Different multiple steps are usually arranged and/or combined to purify the product of interest. An optimized downstream process can help increase product yields, reduce costs and improve the scalability of the manufacturing process. Creative Biogene is able to effectively solve purification problems in downstream production and optimize key process parameters for scale-up production through a variety of advanced purification methods combined with the screening of purification conditions.
Specific activities for downstream development include:
Creative Biogene provides integrated end-to-end bioprocess development solutions to support customers from gene development to finished product. Please feel free to contact us if you have a need, and our experienced specialists will be happy to assist you.
Reference:
Copyright © Creative Biogene. All rights reserved.