As the competition of pipelines in the pharmaceutical industry intensifies, the development of the industry chain is becoming increasingly modular, specialized, and personalized. Traditional CMO (Contract Manufacturing Organization) companies can no longer provide better services to pharmaceutical companies through simple contract manufacturing to meet their higher demands. Especially for innovative R&D-oriented pharmaceutical companies, the demands for efficiency, convenience, and low cost cannot be met by traditional CMO companies. In this situation, new-type CDMO (Contract Development and Manufacturing Organization) companies can inject strong momentum into pharmaceutical companies' growth by leveraging their own R&D technological advantages, professional equipment platforms, comprehensive quality assurance systems, and production capabilities.

With the rapid development of the biopharmaceutical industry, CDMO companies have grown and improved themselves continuously, following the pace of the times and absorbing nutrition from various sources from their nascent stage. They have now presented a stable and efficient situation. Empowered by scientific and technological advancements, CDMO companies' service scope covers CMC services for preclinical research and clinical stages. This includes process development, production, and packaging services for APIs (Active Pharmaceutical Ingredients), intermediates, drug substances, and drug products. While ensuring product quality and stability, CDMO companies continuously optimize processes to reduce production costs and improve efficiency for pharmaceutical companies. Through their technological advantages, they help pharmaceutical companies quickly overcome bottlenecks in drug development stages, saving manpower and time costs, reducing expensive equipment investments, and greatly improving R&D efficiency.

CDMO companies, based on their own strengths, continue to extend their coverage of the industry chain upstream and downstream, completing the closed-loop delivery from concept to product, and from process development to scale-up production. Outsourcing to CDMO companies has become an important path for innovative drug R&D and commercial production in the new era. Both startup pharmaceutical companies and large pharmaceutical enterprises can benefit from the high-quality services provided by CDMOs.

After market refinement, the CDMO industry has gradually become more segmented and customized. Currently, CDMO segments are mainly divided into three categories: small molecule CDMOs, large molecule CDMOs (including peptides/antibodies/proteins/vaccines, etc.), and cell and gene therapy (CGT) CDMOs. Choosing a suitable (reliable) company from among the many CDMO enterprises as a partner for pharmaceutical R&D and production is a major challenge facing pharmaceutical companies today. In response to this issue, Shanghai LKtime Biotechnology Co., Ltd. has provided an answer that exceeds client expectations.

Shanghai LKtime Biotechnology Co., Ltd., located in the core area of Oriental Beauty Valley in Fengxian District, is a professional, one-stop innovative CDMO company specializing in biological drug R&D and production services with both eukaryotic and prokaryotic expression platforms. It is dedicated to providing "butler-style" services from target development to commercial production for antibody drugs, recombinant protein drugs, and other large molecule drugs. Its core team members have been deeply involved in the industry for many years and have experience in developing and filing multiple large molecule biological products. Since its establishment, LKtime Biotechnology has adhered to the principle of "customer first, service supreme", always insisting on advancing projects from the client's perspective.

Currently, LKtime Biotechnology has 5,300 square meters of R&D and pilot-scale GMP facilities, including: one 500L microbial expression system pilot production line, two 200L mammalian cell expression system pilot production lines, and the first commercial production line - a 2000L mammalian cell expression system production line. This allows LKtime Biotechnology to provide end-to-end one-stop services from R&D to pilot-scale and commercial production.

Service Contents

2*200L GMP pilot production line (Drug Substance)

2. Microbial expression platform

Service Items

Service Contents

1*500L GMP pilot production line

3. Drug product GMP pilot production & fill

It can meet the preparation of early clinical samples for multiple dosage forms, including 2ml-50ml vials (Liquids + lyophilized products), 1ml-5ml pre-filled syringes, and 3ml cartridges.

4. Drug product GMP commercial production & fill

The batch production capacity is 15,000 vials, with an annual production of 1.5 million vials. This production line consists of four areas: a general production area, a D-level clean area, a C-level clean area, and a B-level clean area. The general production area includes visual inspection and labeling/packaging processes, the D-level clean area includes the bottle washing process, the C-level clean area includes the cleaning and preparation processes, and the B-level clean area includes the filling and capping processes. The main equipment includes a washing-sterilizing & drying-filling & plugging compact line, a batching system, a pulsating vacuum sterilizer, automatic feeding and discharging systems, and an accompanying vacuum freeze system.

5. Small-volume injection GMP commercial production

The batch production capacity is 25,000 vials, with an annual production of 2.5 million vials of 20ml injection products. This production line consists of three areas: a general production area, a D-level clean area, and a C-level clean area. The general production area includes sterilization, visual inspection, and labeling/packaging processes, the D-level clean area includes the bottle washing process, and the C-level clean area includes cleaning, preparation, and filling processes. The production line features an automatic batching system, with the entire preparation and filling processes protected by nitrogen to effectively prevent product oxidation. The main equipment includes a washing-sterilizing & drying-filling & plugging compact line, a batching system, a rotary sterilizer, a pulsating vacuum sterilizer, a labeling machine, and an automatic packaging machine.

6. Prefilled syringe GMP commercial production

7. Analysis & Quality Control

From the development experience and knowledge of related therapeutic drugs, raw materials, and dressings to the analysis process, release testing, and regulatory, quality experience, and quality systems, as well as from the depth of technical capabilities, maturity of process development, ability to respond to and solve problems, and interest in the product to technical support for the product, LKtime Biotech has always built an efficient and convenient delivery engine while safeguarding the interests of customers. LKtime Biotech's standardized regulatory records and robust warehousing and logistics capabilities lay a solid foundation for its delivery capacity. Excellent project communication skills and a thorough understanding of customers’ requirements also strengthen the bond between LKtime Biotech and its customers.