Medicilon FTE services & FFS services – flexible and efficient cooperation model

Medicilon has a dedicated R&D and project management team. According to customer requirements, it can configure different proportions of R&D staff with different levels of Ph.D., M.S., or B.S. degrees to form a joint R&D team with customers to quickly and efficiently solve the technical problems of their R&D projects, and to provide regular project progress reports and project communication meetings. Moreover, Medicilon can quickly adapt to the client’s needs and provide efficient output to ensure the smooth progress of the project. This partnership model is ideal for innovative drug development projects.

The Medicilon Chemical FTE team can serve clients at different stages of drug development, including generation and optimization of lead compounds, identification, and optimization of lead compounds, synthesis scale-up, and chemical process studies. This collaboration model allows for flexible adjustment of R&D staffing, experimental protocols, and project priorities based on client and project needs.

The research department will communicate with the customer when problems are encountered in the R&D process and propose solutions to solve them. In addition, the FTE team can not only synthesize according to the synthesis line designed by the customer but also design the synthesis line according to the customer’s concept. Flexible adjustment based on project requirements makes project progress clear and controllable, and provides exclusive synthesis circuit design and problem solving, all of which reflect the service advantages of the Medicilon FTE team.

FFS custom synthesis is one of Medicilon’s services. Medicilon has an experienced R&D team of Ph.D., M.S., and B.S. degree researchers who constitute a golden mix and will utilize their extensive biopharmaceutical and medicinal chemistry experience to complete a variety of different custom synthesis projects including the synthesis of biologically active molecular target compounds, and other drug-like intermediates regularly.

The custom synthesis will be developed exactly to the customer’s requirements for the compound, either in small (typic milligrams to 100 grams) or medium to large (typically 100 grams to kilograms) quantities. These drug-like substances include drug reference compounds, lead compounds and their derivatives, combinatorial chemical templates, and other drug-like compounds with or without references. We can deliver custom synthesis products in a timely and efficient manner. The fees charged for the FFS model depend on the type of specific experiment, the method and the number of compounds to be tested, etc.

Feasibility assessment of new drug targets

High-throughput screening and discovery of active compounds based on  structural design

Establishment of specific compound libraries (establishment of macromolecule compound library)

Rapid synthesis of PROTAC molecules and ADC payloads, as well as lipids, glycolipids, and phospholipids

Screening of new hit compounds from DEL (from active compounds to discovery of lead compounds)

Synthesis, discovery, and optimization of lead compounds

Research on SAR

Computer-aided drug design (CADD)

Processes from optimization of lead compounds to determination of preclinical drug candidates

Synthesis of reagents, intermediates, building blocks, reference compounds, metabolites, and impurities

Synthesis of Reference Compounds

Synthesis of customer-specific structure compounds

Preparation of APIs or related substances

Synthesis of standard substances

Synthesis design and preparation of impurities or metabolites

Synthesis of stable isotope internal standards

Synthesis of tritiated compounds

Synthesis and disassembly of chiral compounds

Scale-up synthesis and process optimization of preclinical candidate compounds

Synthesis of high-quality kilogram-level samples

Research on target compound synthesis technology

Separation of impurities in regulated starting materials, intermediates, APIs, and drug products using various techniques such as HPLC complete data – including 1D/2D NMR, LCMS, EA, HRMS, IR, and UV – to identify the structure of the separated impurities Collecting

Isolating and identifying the structures of API degradation products by forced oxidation

Employment of QNMR to quickly determine the contents of crude materials, intermediates, API, and synthetic impurities

NMR 1D, 2D, etc. (including H-NMR, C-NMR, P-NMR, F-NMR, HSQC, HMBC, COSY, and NOESY)

LC-MS analysis

HPLC analysis (including ELSD detection)

Chiral purity testing

Preparation and separation in Pre-HPLC

Routine physical and chemical tests  (ROI, LOD, Cl-, SO4^2-, mp, HM, optical rotation, moisture determination, heavy metal residues, etc.)

Efficient team performance parameters.

Free for service (FFS) on-time delivery rate > 80%;

Chemical reaction success rate > 85%.

Compound delivered per full-time employee (FTE) each week;

The number of reactions completed by each scientific researcher > 12.

Design and Synthesis of Target Protein PROTAC-POI

In vitro screening of PROTAC-POI

In Vivo Efficacy Tests of PROTAC-POI

PK/PD studies, pharmacological analysis, pharmacokinetic studies, and safety evaluation

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