LKtime's Downstream Department specializes in several key areas: purification process development, process scale-up, sample preparation, process characterization and process verification. The product range includes antibodies (mAb, bsAb, msAb), nanobodies, Fc fusion proteins, recombinant proteins, plasmids, enzymes, etc. Dedicated to providing our clients with stable, reliable, and high-quality services, we are focused on significantly expediting the commercialization cycle of biopharmaceutical products. The commitment ensures that our clients receive the most efficient and scientifically advanced solutions to meet their needs.

- Tailored purification processes and optimized process parameters are designed based on clients’ requirements and the inherent characteristics of the target molecules to enhance the product purity and yield. Specific methodologies and protocols suitable for the purification of target proteins are developed and validated, encompassing affinity chromatography, ion exchange chromatography, hydrophobic interaction chromatography, gel filtration, ultrafiltration, and other technologies, as well as the determination of corresponding operating conditions.

- This process primarily involves low pH treatment, nanofiltration, S/D treatment, among others.

- In accordance with clients’ specifications, the laboratory-scale purification process will be scaled up and transferred to accommodate production-scale operations. This includes the selection and configuration of appropriate equipment, adjustment and optimization of process parameters to ensure consistent product quality and yields in large-scale manufacturing.

- A data management system is implemented to record, store and analyze data from the purification process, and to generate corresponding reports. This facilitates clients’ comprehension of key parameters and results pertaining to the purification process, supporting informed decision-making and further process improvements.

- All projects adhere to relevant regulatory requirements and quality management system requirements.

- LKtime offers comprehensive downstream development platforms to support a series of process development activities and meet diverse clients demands across multiple projects.

- Small-scale process development can be seamlessly transitioned to pilot-scale amplification or process transfer within 2 months.

- LKtime maintains a stringent quality control system to ensure product quality meets relevant standards and requirements.

- Projects are assessed based on scientific principles to mitigate or avoid potential risk.

- Excellent scalability enables meeting production needs across different scales.

- Customized services can offered, including preclinical process development, IND application support, early clinical sample production, late clinical process verification, risk assessment  and control, process characterization research, and assistance with NDA / BLA submission.