- A competitive dual expression platform has been established, including a mammalian cell expression platform and a microbial expression platform. 

- Comprehensive service offerings: Capable of development and production for conventional biologics such as antibodies (mAbs, bsAbs, msAbs), recombinant proteins, polypeptides, ADC naked antibodies, plasmids, enzymes, etc. 

- Planning and establishing a gene therapy drug (mRNA, AAV, LV, etc.) R&D platform, laying out an overall CGT solution. 

- The core team members have worked in the innovative biopharmaceuticals for many years, coming from renowned biotechnology companies and top research institutions at home and abroad. They possess extensive experience in biopharmaceutical production quality control and clinical trial permission application. The team has assisted clients or participated in no less than 50 IND applications in China, multiple INDs in the United States and Australia, and has successfully passed numerous on-site inspections of drug registration.

An “7 + 1” distinctive service platform has been established to assist clients in accelerating IND applications. The platforms can collaborate seamlessly and efficiently to ensure smooth project flow.

① Cell line / Strain Construction Platform

Features:
· Various host cell expression technologies
· Site-specific recombination technology
· Yeast high expression technology
Advantages:
· Meeting 90% of project demands in the industry.

② msAbs platform

Features:
· The same molecule can be designed as bsAbs (bispecific antibodies) and msAbs using asymmetric and flexible design.
Advantages:
· The molecules designed on this platform have low immunogenicity, controllable impurities, and low aggregation.

③ Cell process development and production

Features:
· Cell high expression technology
· It can be scaled up from 2L to 2000L in a single step.
Advantages:
· mAb expression level: 4-10 g/L; bsAb expression level: 2-8 g/L; vaccine expression level: 1-3 g/L. Expertise in high-complexity projects, with expression levels over 50% higher than the industrial average level.
· The cell culture process scale-up time can be saved at least one month.

④ Yeast process development and production

Features:
· Yeast high expression technology
Advantages:
· The average expression level is above 10 g/L; the production costs of non-glycosylated drugs can be saved more than 70%.

⑤ E.coli process development and production

Features:
· Applying closed solid-liquid separation system and bacterial crushing process equipment.
· Distinctive inclusion body denaturation and renaturation technology.
· Monolithic column chromatography.
Advantages:
· Closed production avoids exposure operations during the process and reduces the risk of cross-contamination.
· It can meet various purification process requirements for protein secretion expression, intracellular soluble expression, and inclusion body expression.
· The renaturation efficiency can reach up to over 95%, far exceeding the industry average level.
· The chromatographic resolution is over 20% higher than ordinary columns, and it can be scaled up to any size in a single step.

⑥ Drug product development and manufacturing

Features:
· Extensive experience in developing various types of formulations, including formulations for molecules with poor stability, ultra-high/ultra-low concentration, and other challenging projects.
Advantages:
· Extensive experience in formulation development, process development, technology transfer during clinical trials, PC &PV before BLA filing, ensuring completion of all stages of drug product development required product marketing.

⑦ CGT platform

Features:
· It has CRISPR-Cas9 gene editing technology & LNP development technology.
Advantages:
· Ability to construct propriety mRNA sequences; possess GMP-compliant plasmid production platform; develop LNPs specifically targeted for small molecules, proteins, and cell, with rapid scale-up production.

⑧ Quality analysis platform

Features:
· Expertise in the analyzing various challenging biological products (protein drugs and gene therapy drugs).
· Multi-technique integrated multi-dimensional analysis.
Advantages:
· Involvement in analytical testing from molecular design stage reduces drug development risks.
· Seamless integration with all process stages accelerates project development cycle.

- Maintains unimpeded communication with clients at all times.

- Rapid feedback, flexible solutions, strong initiative, and high degree of cooperation.

- Ability to provide high-quality customized services according to client's needs.

- LKtime’s cGMP manufacturing facilities are designed and constructed in accordance with current regulations and guidelines from China, the United States and the European Union.

- Established quality management system ensures compliance with regulatory requirements for early IND and subsequent BLA applications, with the capability to file in multiple countries including China, the United States, EU and Australia.

- End-to-end “visualization” services from molecule to IND application, making clients feel at ease and assured at every milestone.

- Comprehensive IP protection to ensure clients information is properly safeguarded.

- Completed 3 batches of pilot production within 7 months from RCB (standard is 12 months).

- Antibody drug project completed from cell line to clinical batch release in 12 months (standard is 16-20 months).

- Through outstanding technical service quality and delivery performance, gained clients’ high trust and recognition, resulting in a 100% client renewal rate.