• 中文版
  • Home
  • About Us
    • Contract Research Organization
    • Contract Development and Manufacturing Organization
    • Accolades
    • Publications
  • Services Overview
  • Discovery Chemistry
    • Synthetic Chemistry
    • Medicinal Chemistry
    • Library Chemistry
    • Peptide Chemistry
    • Fragment Based Screening
    • Computer Aided Drug Design
    • Analytical Services
    • Protein Structure
  • Biology & Pharmacology
    • Oncology
    • Pathology Core Facility
    • Immunology
    • Tumor Immunology
    • Neuroscience
    • Cell Biology
    • In Vitro Biology
      • Kinases
      • Epigenetics
      • GPCR, NR, Ion-channel, Transporter
      • Ubiquitin & PROTAC
      • KRAS
      • COVID-19
      • Radiometric
      • Customized assay development
      • High throughput screening
      • MOA Study
    • Metabolic & Cardiovascular Diseases
  • DMPK / Exploratory Toxicology
    • DMPK / Exploratory Toxicology
    • Biomarkers, Preclinical & Clinical Sample Bioanalysis
    • Large molecule PK/BA services
  • Biologics Discovery
    • Antibody Discovery
    • Protein Science
    • Biologics Analytical Services
    • B Cell Cloning
  • Biologics CMC
    • Stable Cell Line Development
    • Process Development
    • Formulation Development
    • Aseptic Filling and Freeze-drying
    • Drug Developability / Manufacturability study
    • Final Container Extractables & Leachables Study
    • Analytical Development and Testing
    • GMP Production
  • Small Molecule CMC
    • Process R&D Services
    • Process Safety
    • Analytical Development
    • Pre-Formulation Development
    • Formulation Development
    • ICH Stability Studies
    • CMC CTD Support
    • Manufacturing
  • Blog
  • Careers
  • News & Events
    • Webinars
  • Contact Us
  • Download Center

Call us today! +86 21 5132 0088

contact@chempartner.com
中文版
Shanghai ChemPartner Shanghai ChemPartner Shanghai ChemPartnerShanghai ChemPartner
  • Home
  • About Us
    • About ChemPartner
    • CRO
    • CDMO
    • Accolades
    • Publications
  • Services
    • Discovery Chemistry
      • Synthetic Chemistry
      • Medicinal Chemistry
      • Library Chemistry
      • Peptide Chemistry
      • Fragment Based Screening
      • Computer Aided Drug Design
      • Analytical Services
      • Protein Structure
    • Biology & Pharmacology
      • Oncology
      • Pathology Core Facility
      • Immunology
      • Tumor Immunology
      • Cell Biology
      • In Vitro Biology
      • Neuroscience
      • Metabolic & Cardiovascular Diseases
      • Epigenetics
    • DMPK / Exploratory Toxicology
      • DMPK / Exploratory Toxicology
      • Biomarkers, Preclinical & Clinical Sample Bioanalysis
      • Large molecule PK/BA services
    • Biologics Discovery
      • Antibody Discovery
      • Protein Science
      • Biologics Analytical Services
      • B Cell Cloning
    • Biologics CMC
      • Stable Cell Line Development
      • Process Development
      • Formulation Development
      • Aseptic Filling and Freeze-drying
      • Drug Developability / Manufacturability study
      • Final Container Extractables & Leachables Study
      • Analytical Development and Testing
      • GMP Production
    • Small Molecule CMC
      • Process R&D Services
      • Process Safety
      • Analytical Development
      • Pre-Formulation Development
      • Formulation Development
      • ICH Stability Studies
      • CMC CTD Support
      • Manufacturing
  • Blog
  • Careers
  • News & Events
    • Webinars
  • Contact Us
  • Download Center

Formulation Development

Home Small Molecule CMC Formulation Development

Formulation Development

The Formulation Group specializes in the development of novel solid and liquid dosage forms. Liquid dosage forms such as oral solutions, suspensions, and injectables have become the focus for pre-clinical safety evaluation in the industry. We are proud to provide these services, along with oral solid dosage formulation development and manufacturing of clinical trial material, at our state-of-the-art Zhang Jiang facility. Our formulation service provides our clients with essential support for pivotal GLP studies, subsequent clinical trials, and later stage development in a timely, cost-effective manner. We have the capability and expertise to manufacture drug products suitable for Chinese SFDA and USA FDA clinical studies.

Preclinical Formulation Development

  • IV/oral liquid formulations for PK, pharmacology, and non-GLP tox studies
  • Integration with internal drug discovery capabilities in Medchem, Biology, DMPK, and Toxicology
  • Use up-to-date technologies to optimize preclinical formulations to support drug discovery programs

Technologies for Poorly Soluble Compounds

  • SEDDS formulation
  • Nanosuspension (wet media milling)
  • Emulsion, microemulsion, lipid based complex and micelle formulation
  • Solid Dispersions: micro-crystalline or amorphous form with carrier matrix
  • Solubilizing Agents: cyclodextrins, surfactants, polar organic solvents

Early Phase Clinical Formulation

  • Powder in Capsule (PIC)
  • Powder in Bottle (PIB)
  • Tablet
  • Liquid formulation

Oral Solid Technologies

  • Wet granulation (high shear, fluid bed, extrusion spheronization)
  • Dry granulation (roller compaction)
  • Nanosizing in solid dosage form
  • Tabletting, hard shell and soft-gel capsulation
  • 0.1-20 kg capacity (for SFDA studies and FDA studies)

Injectable Formulation Technologies

  • Sterile fill-finish (terminal sterilization, filtration and sterile filling)
  • Lyophilization (Lyostar II with SMART technology, and in-process sample extractor)
  • Nanosizing technologies (Microfluidizer and Dyno-mill)
  • Service Overview
  • Discovery Chemistry
    • Synthetic Chemistry
    • Medicinal Chemistry
    • Library Chemistry
    • Peptide Chemistry
    • Fragment Based Screening
    • Computer Aided Drug Design
    • Analytical Services
    • Protein Structure
  • Biology & Pharmacology
    • Oncology
      • OncoCP Database
    • Pathology Core Facility
      • Histopathology
      • Molecular Pathology
    • Immunology
      • Primary immune cell assays
      • Immune cell line assays
      • Autoimmune disease models
      • In vivo PD models
      • Immune profiling for MOA
    • Tumor Immunology
    • Neuroscience
      • Volume Discount Fast services for Neuroscience
      • Behavioral Pharmacology
      • In vivo Pain Models
      • Non-Human Primate Cognition
      • In Vitro Electrophysiology
    • Cell Biology
      • Target Validation
      • Cell-based Assays
      • Cancer Cell Line Panel Screen
      • Biomarker Analysis
    • In Vitro Biology
      • Kinases
      • Epigenetics
      • GPCR, NR, Ion-channel, Transporter
      • Ubiquitin & PROTAC
      • KRAS
      • COVID-19
      • Radiometric
      • Customized assay development
      • High throughput screening
      • MOA Study
    • Metabolic & Cardiovascular Diseases
  • DMPK / Exploratory Toxicology
    • DMPK / Exploratory Toxicology
      • In vitro ADME
      • Pharmacokinetics
      • Exploratory Toxicology
      • Bioanalysis
      • Regulatory filing
    • Biomarkers, Preclinical & Clinical Sample Bioanalysis
    • Large molecule PK/BA services
      • Monoclonal Antibodies
      • Antibody Drug Conjugates
      • Bispecific Antibodies
      • Proteins & Peptides
      • Immunogenicity
  • Biologics Discovery
    • Antibody Discovery
      • Hybridoma
      • Antibody Engineering
      • Phage Display
      • Antibody-Drug Conjugate
    • Protein Science
    • Biologics Analytical Services
      • mAb Release Tests and Extended Characterization
      • Antibody-Drug Conjugate(ADC) Analysis
      • Therapeutic Protein Characterization
      • Biomolecular Interaction Analysis
    • B Cell Cloning
  • Biologics CMC
    • Stable Cell Line Development
    • Process Development
    • Formulation Development
    • Aseptic Filling and Freeze-drying
    • Drug Developability / Manufacturability study
    • Final Container Extractables & Leachables Study
    • Analytical Development and Testing
    • GMP Production
  • Small Molecule CMC
    • Process R&D Services
    • Process Safety
    • Analytical Development
    • Pre-Formulation Development
    • Formulation Development
    • ICH Stability Studies
    • CMC CTD Support
    • Manufacturing

Give us a Message

You can leave us a message by quick contact box and we'll get back to you, asap. Thanks!

Send Message

Logo

ChemPartner is a leading research organization providing high-quality and cost-effective services for the pharmaceutical and biotechnology industry.

Get started today.

Contact Us
  • Shanghai ChemPartner Co., Ltd.
  • 1F & 3F, Block A, 2829 JinKe Road, Zhangjiang Hi-Tech Park, PuDong New Area, Shanghai China, 201203
  • +86 21 5132 0088
  • contact@chempartner.com

© 2021 — Shanghai ChemPartner Co., Ltd. All Rights Reserved  About Us  Careers  Contact Us  Privacy Policy  Sitemap

  • Home
  • Contact
  • Buy Highend