Pharmaceutical Research CDMO Service

• 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 can help clients flexibly transfer capacity pressure and reduce both the time and cost required to transform products in the trial period.
  Medicilon’s One-Stop Pharmaceutical Research CDMO 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 saving time and cost for customers.

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 can provide innovative process research and development and large-scale production services for clients.
  
  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
  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 can provide innovative process research and development and large-scale production services for clients.
  
• Experimental Equipment
  Medicilon's process department is equipped with state of the 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 rapidly and effectively and to help clients to control the new drug development costs.
  
• Continuous Improvement of Technological Innovation
  Alongside our significant capability in chemical drugs R&D, Medicilon has expanded into the field of biological macromolecules. Medicilon has established the R&D and production systems for small nucleic acid drugs and antibody drugs.In 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

  

  Drug analysis platform

  

  Nucleic Acid Drug R&D 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 can flexibly carry out preparations with different production processes and different production batches (1kg-40kg).
  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
  The Medicilon GMP preparation analysis laboratory uses a sophisticated set of quality management systems, which can not only meet the QC inspection and requirement for the GMP workshop, but also 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, that keeps up with the pace of innovation in drug research and development, and meets the diverse requirements of clients.  Medicilon has facilitated a number of innovative drugs to successfully obtain 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 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 hasexperience of production processes of different ophthalmic preparations such as terminal sterilization, aseptic operation, BFS blow-fill-seal, etc.  Medicilon has also accumulated broad 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.Professional Platform for Special Drug Delivery SystemsInhalation Drug Delivery, Ophthalmic Drug Delivery, Transdermal Drug Delivery, Sustained and controlled release drug delivery and New Type Particle System Administration.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 and bioequivalence studies.

Service Cases

FAQs

• What are the Main Factors that Affect the Speed of R&D?

  • Long lead time for salt structure screening and crystal structure screening

  • Insufficient depth in the development and optimization of analytical methods, resulting in repeated efforts.

  • Challenges in quickly identifying an optimal API purification method during process optimization.

  • Delays in impurity studies, preventing rapid method validation.

  • Inadequate coverage of impurities in the safety assessment batch.

• What is the Goal of Process Development?

  The goal of API manufacturing process development is to establish a commercial manufacturing process capable of consistently producing the API of expected quality.

• Characteristics of an Excellent API Synthesis Process

  • Feasibility

    Whether the adopted process route can produce the target compound

    Whether the reaction conditions can meet the requirements of the industrial process route for raw materials, equipment, and reaction conditions in the commercial production

    Resolution of waste management issues

  • Controllability

    Good reproducibility

    Consistency in product quality between batches, meeting expected quality standards

  • Rationality

    Raw materials: readily available

    Selection of solvents and reagents: Preferably low toxicity, in accordance with ICH guidelines

    EHS: Environmental protection and labor protection comply with laws and regulations

    Cost: Competitive

    

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