Pharmaceutical Research CDMO Service Platform

Pharmaceutical CDMO can provide clients with innovative R&D services including process chemistry, formulation and industrial production. Pharmaceutical CDMO fully integrates and deeply connects all phases of drug R&D, including the preclinical study, the clinical trials and the commercialization.
Why Choose CDMO?
Comprehensive Optimization: CDMO can optimize R&D projects thoroughly from different perspectives, such as medicinal chemistry, physical/chemical properties, PKPD, etc., based on innovative technology platforms, rich R&D experience, rigid quality system and strict IP protection. Cost Control: CDMO services could help clients flexibly transfer capacity pressure, reduce the time and cost required to transform products in the trial period.
Medicilon One-Stop Pharmaceutical Research CDMO is an integrated platform that integrates "APIs + Preparations", and is committed to the technological innovation optimization and commercialization of global pharmaceutical processes, from product development, quality research, quality control, production and declaration to help the new drug research and development in saving time and cost for enterprises.

One-stop API Technology R&D Platform

The Medicilon Process Department is deeply involved in the entire industrial chain system of the R&D, procurement and production, from preclinical small-scale synthesis route optimization, process development and scale-up, process validation, quality research to commercial production. Medicilon Process Department could provide innovative process research and development and large-scale production services for the enterprises.
The process department currently has a total area of about 6000 m², including：
2000 m² of R&D lab800 m² of non-GMP pilot scale up workshop1000 m² of GMP API workshop1000 m² of analysis and testing center800 m² of GMP compliant QC lab, and 200 m² of microbiology lab.

Multifunctional R&D Testing Base
Medicilon Process Department owns the R&D laboratory, the non-GMP scale-up workshop, the GMP standard API workshop and analysis and testing center, GMP-compliant QC laboratory, microbiology laboratory and other test bases, integrating R&D, production, quality control, safety assessment. Medicilon not only provides clients with customized services for GMP production, but also carries out R&D, production, inspection and stability research of innovative drugs clinical phase I/II and generic drugs.
Complete Experimental Equipment
Medicilon's process department is equipped with state-of-art instruments and lab equipment, which enables the accomplishment of clients' drug research and development projects with high standards and efficiency. Our goal is to assist the R&D projects to enter clinical trials in shorter time and effectively help clients to control the new drug development costs.
Continuous Improvement of Technological Innovation
Apart from our mature capacity in chemical drugs R&D, Medicilon has steadily expanded into the field of biological macromolecules. Medicilon has established the R&D and production systems for small nucleic acid drugs and antibody drugs. within addition, we have advanced our technology in salt and crystal form screening, process safety research, improvement and innovation of quality research systems.
Related Platforms：
Process Department Solid Form Screening Platform
Safety Assessment Lab of Process Chemistry
Nucleic Acid Drug R&D Platform
Drug analysis platform

Preparation CDMO Service Platform

Medicilon preparation CDMO can undertake the whole process of preparation research and development from project evaluation, pre-prescription research, preparation process research, quality research, clinical sample production, stability research and registration filing, which could comprehensively assist the research and development of innovative drugs.
Innovative Drug CDMO Services
Preformulation researchFeasibility evaluation, dosage form selection, Drug-Excipient Compatibility StudiesFormulation process research Formulation development, formulation process optimization and quality development.IND, phase I clinicalPilot scale-up, quality study and stability, phase I clinical samplesPhase II/III clinical trialsProcess enlargement and changePhase II clinical samplesPhase III clinical samplesNDAPrescription process confirmation Quality researchProcess Validation
Generic drug CDMO service
Preformulation researchRaw material properties Raw materials compatibility Reference preparation research and reverse engineeringFormulation process researchQTPP, CQAs, QbD, DoE, CMA, CPP, DS quality researchProcess scale up CQAs, CPP, in vitro and in vivo consistency and stability studiesProcess ValidationAnalytical method validationProcess ValidationListing applicationProcess ValidationApplication materials.
Dosage forms
Oral preparations (tablets, capsules, granules, oral solutions/suspensions, syrups)Injection preparations (injection, sterile powders for injection (sterile packaging or freeze-drying), solution for injection) External preparations (ointments, creams, tinctures)Other preparations (eye drops, sprays, inhalants, sustained release agents )
Category of Registration
1 original new drug 2 modified new drug3、4 generic drugConsistency evaluation Supplementary application
High Quality Production Service
Medicilon has established a variety of dosage form research and development laboratories, non-GMP scale-up workshops, GMP oral solid preparation workshops and GMP-compliant QC laboratories. With advanced equipment configuration and complete functions, Medicilon could flexibly carry out preparations with different production processes and different production batches (1kg-40kg).
Among them, the GMP oral solid preparation workshop can perform services such as raw material crushing, weighing, mixing, granulation, drying, granulation, tablet compression, capsule filling, coating and packaging. Medicilon's clinical production packaging can provide product-labeling options required for single-blind and double-blind clinical trials, and provide different types of clinical production services that comply with current GMP standards according to client requirements.
Management System with High Standard
Medicilon GMP preparation analysis laboratory owns a sophisticated set of quality management system, which can not only meet the QC inspection and requirement for the GMP workshop, but also meet the requirements of long-term stability and accelerated stability research under GMP conditions for the consistency evaluation of generic drugs. The system covers every stage, specifies the responsibilities of departments and corresponding management personnel and establishes a complete documentation system. The system is managed in full accordance with GMP specifications to ensure stable and reliable product quality, traceable quality profiles, complete functions, and flexible production, especially for the preparation of samples for Phase I clinical research.
High-Level Formulation Development
Medicilon has a professional high-end formulation technology platform, keeps up with the pace of innovation in drug research and development, and meets the diverse requirements of clients. Medicilon has helped a number of innovative drugs to complete the R&D and successfully to get approval for clinical use.
Inhalation Drug Development Platform: Medicilon has extensive research and development experience in dry powder inhaler (DPI), aerosol inhalation and nasal spray formulations. During the research process, the research work will also be fully combined with the requirements of domestic and overseas regulations and guiding principles. Ophthalmic Drug R&D Platform:Medicilon has rich experience in R&D of different ophthalmic dosage forms such as ophthalmic solution, suspension, eye ointment, gel, etc. Medicilon accumulated the experience of production processes of different ophthalmic preparations such as terminal sterilization, aseptic operation, BFS blow-fill-seal, etc. Medicilon also accumulated rich experience in registration filing. R&D Platform for Topical Skin Preparations:Medicilon’s R&D Platform for Topical Skin Preparations can undertake the development of ointment, cream, gel and other semi-solid preparations. Medicilon has completed the R&D and filing of several topical preparation research projects for pharmaceutical companies and scientific research units.
Highlights of Formulation Development
Professional Platform for Insoluble CompoundsHot Melt Extrusion, Micronization, Solubilization Techniques, Comprehensive Evaluation of in Vitro and In Vivo, etc.Professional Platform for Special Drug Delivery SystemsInhalation Drug Delivery, Ophthalmic Drug Delivery, Transdermal Drug Delivery, Sustained and controlled release drug delivery, New Type Particle System Administration, etc.Perfect System of GMP Production and QA GMP workshop for oral solid dosage, GMP Analysis Labs, and GMP standard QA system.Rich Experience in NME Drugs and GenericsRich experience in innovative new drugs, generics, and 505b2 drugs, for NMPA and FDA Registration.One-Stop Services for Formulation Services Including a full set of formulation development and clinical stage manufacture, safety evaluation, Packaging materials compatibility, Filter validation, Bioequivalence Studies.