Innovation and Creation
Live a Healthier Life
MEDICINAL RESEARCH SERVICE
Scale-up of intermediates, building blocks, Template
SCALE-UP
ANALYTICAL SUPPORT
ORGANIC SYNTHESIS
HPLC-MS, LC-MS-MS and GC-MS,SFC
NMR（400MHz,500MHz）
Semi-prep and Prep-HPLC
Mass-triggered Prep-HPLC
Chiral separation：Semi-prep scale chiral hplc
Chemical Intermediates, Building Blocks,Template Synthesis
Reference Compounds Synthesis
Metabolites & Impurity Synthesis
Synthetic Route Discovery, Selection and Development
Combinatorial Compound Library
Diversity Compound Library
Focused Compound Library For SAR Study
Asymmetric Synthesis of Chiral Compounds
Asymmetric Synthesis
Screening of Ligand & Manufacturing
Enzyme catalysis & resolution thechnology
MEDICINAL CHEMISTRY RESEARCH SERVICE
Our drug discovery programs: anticancer, anti-inflammatory, central nervous system, Immune system, Metabolic disease
Our Drug Discovery Services ：Computer Aided Drug design, SAR study, lead optimization.
Research on new Drug：Special on New drug design, drug synthesis, integrated drug discovery, targeting drug delivery system
Research on Manufacturing : Chemical process development, chiral synthesis, analytical research development, formulation research development, and other advanced technologies in pharmaceutical R&D business.
Discover new multi-types compounds with better physicochemical and Pharmacokinetic properties which Comply with relevant
Lead and Target drugs: Biological enzymes, ion channel, G-protein coupled receptor and other biological target drugs, set up relative IP rights and supplication.
The synthesis, separation and identification of organic compounds : chiral compounds & heterocyclic compound
PROCESS & MANUFACTURE DEVELOPMENT
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Five of modern-equipped process chemistry laboratories with eighty fume hoods and twenty walk-in fume hoods
Two kilo laboratory of non-GMP standard with twenty walk-in fume hoods ,Twelve reactors from 25 L to 100 L
One kilo laboratory of GMP standard with eleven walk-in fume hoods, Twelve reactors from 30 liters to 100 liters, all facilities compliance with US FDA cGMP regulations
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Pilot Production Capacity(Kilogram scale)
GLS/SS materials of reactors： 100 L to 5,000 L
Temperature Range: -70° C to +250°C
Working Pressure：0.1 MPa~6 MPa
high vacuum ：-0.95MPa
R&D Lab (mg to kg scale)
R&D Labs & Production Facilities
More than 40,00 square feet of R&D lab space locate in XianLin University Town, Nanjing .
We could provide Contract Research and Contract Manufacturing services from gram scale,kilogram scale to metric ton scale here.
More than 2500 square feet of API production facility locate in Zhenjiang City, Jiangsu province. We could provide Contract Research and Contract Manufacturing services from kilogram scale to metric ton scale here. And, the transform from pilot scale to commercial scale is very smoothly.
A technical driven company which has a young, stable and experienced core R&D team. The key and special members of Technical team have many years of experience in new drug research, development and pharmaceutical outsourcing service business. Our company has more than 120 staffs and more than 60% have a doctorate or a master's degree. More than 20% of the staff has foreign educational background or work experience.
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Through long term efforts, Gear has seized many years experiences of accumulated technology on Design of Organic Synthesis, process R&D, analytical method development and Optimized Method, supply full service from R&D to Manufacturing.
We can supply APIs which are used for preclinical and pre-formulation studies. Our services further extend to relatively large scale kilo lab synthesis as our client's program moves to phase I clinical studies. At this stage, we can help client identify the synthesis route and optimize the process, followed by non-GMP and/or GMP required synthesis of intermediates and APIs. As your clinical program moves forward, we can make more intermediates and APIs to support your Phase II and III clinical trials and commercialization needs in our production site.
We also provide service for our clients to develop better and/or non-patent infringing processes for many drugs which are already in the market and provide CMO services for our clients either under non-GMP or GMP conditions.
We ensure on-time delivery of low cost and high quality chemicals to meet all your needs. Gear continued investment in developing new organic synthetic technology, like continuous processing, enzyme chemistry , will strengthen our expertise both domestically and globally.
Service Content
Technology Specialties
Screening of
synthetic routes
Preparation of
impurities
Process scale-up
verification
Process limits
test & risk
assessment
Continuous process optimization
Salt and polymorph
screening
ANALYTICAL SERVICE
25°C/60%RH
30°C/65%RH
40°C/75%RH
30°C/35%RH
Equiped with dedicated stability program manager and facilities.
Stability studies include preparation and approval of stability
protocols, sample management, sample testing, data and trend analysis and filing documentations Stability of API and drug product indicating method validation and transfer
Stability conditions include:
HPLC : Agilent & DIONEX
HPLC-CAD
HPLC-ELSD
GC
LC-MS
GC-MS
LC-MS-MS
SFC
NMR 400, 500MHZ
UV
FTIR
Karl-Fischer Moisture Meter
CGMP Compliant facilities validated IQ/OQ/PQ and Calibrated regularly
Method development and validation for starting materials, intermediates, and APIs
Method development and validation for drug product
Testing and release of APIs and drug products
Supportive tests for process studies and manufacture
Identification of impurities and structure elucidation and confirmation
Separation of chiral compound
Chemical/physical characterization of APIs
Qualification of reference standards
Testing and confirmation of residual solvent
CFDA/FDA COMPLIANT METHOD DEVELOPMENT/VALIDATION AND QUALITY STUDIES
SERVICE SCOPE
Gear's Analytical research and development (ARD) team offers high-quality analytical services including method development and validation,
qualification of reference standards, testing and release studies, stability studies, CMC dossier preparation services. Our team has collaborated with China and Global pharmaceutical companies. Gear is committed to delivering cost effective and high quality analytical services to clients.
Integrated services with high quality and fast turn-around time Strong experiences and regulation knowledge contribution to IND, NDA and ANDA projects
STABILITY STUDIES FOLLOWING ICH/USP/GMP GUIDELINES
ANALYTICAL FACILITIES
FORMULATION SERVICE
Formulation screening using stability,
dissolution and animal PK
Process development based on desired dosage form and physicochemical and physical properties of drug substance
Scale up process design and optimization
Technology transfer to clinical manufacturing sites
Storage and shipping conditions assessment and recommendation
Establish suitable quality specifications for formulation intermediates and finished products
Formulation and process development
SERVICE COMPETENCES
Solubility, stability, compatibility, logP testing
Polymorph screening and selection
Salt form screening and selection
· Dissolution in different media and release behavior comparison
· Physicochemical profiling, Drug developability assessment
Pre-formulation and discovery support
REGULATORY FILING
CMC filing documentations in CTD
format for IND/NDA/ANDA submission
of samples and results of test research
according above total research
Single&Multi-Tablet Press
Formulation research and development team provides a full range of service modules including pre-formulation study,
formulation and process development, technical transfer, and regulatory filing. We provide full range of service modules aiming to provide "One-Stop Shop" formulation/product development services to meet clients' development needs at various stages.
PRE-CLININICAL DEVELOPMENT
EQUIPMENT
Three-Dimensional Motion Mixer
High Shear Vertical Granulators (1L ~ 25L)
Multi-Function Fluid Bed Granulator
Airflow Pulverization Instrument
Roller Compactor
Grinding&Granulate Machine
Efficient-Pan Coater
Auto-Dissolution Station
Dynamic Moisture Vapor Sorption (DVS)
Freezer Dryer
Particle Size Analyser
MANUFACTURING
Manufacturing facilities & storage：
3,000 sq. ft.
Utility：
frozen saline water cooling, compressed air, soft water
Steam：
centralized supply by the industrial park
Non-GMP pilot plant ：
Non-GMP pilot plant with 20 reactors with capacity from 300L-5,000L
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CORE COMPETENCES
Robust Quality Management
Geer’s Quality Assurance Unit (QAU) has established a FDA cGMP compliant quality system to ensure the quality of its services and products. Our employees are trained and qualified in all aspects (operational, safety, data integrity, confidentiality, etc.) prior to working independently on our clients’ projects. Hundreds of SOPs were established to ensure the quality of service from raw materials to final products, from laboratory to pilot plant, and from operator to chief executive officer. Geer has successfully passed hundreds of audits from global pharmaceutical companies and health authorities around the world
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Quality Assurance
We have standard operating procedures, training management, good documentation practice, archive management, material management, specification management, vendor qualification and contract manufacturer qualification, calibration and maintenance, quality incident management, including deviation, OOS, customer complaint, and product recall as well as change control , validation and qualification management, package and label management, internal audit and routine inspection.
At our ZhenJiang plant, we are ICH Q7 compliant and have four level documentation framework, batch record reviews, change control and deviation investigation, CoA review and approval, robust training program and over 200 QA related SOPs in place
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A perfect EHS system
EHS policy
Strictly complies with all applicable national and local EHS laws, regulations and standards
Suitable internal SOPs are well established and implemented for EHS controls
EHS Accountability
EHS Department is responsible for providing guidance, robust training for all of hazardous reactions, field safety, regular safety assessment report and other safety related issues
Sustainability
Strictly control the discharged quantity of waste, improve the wastes treatment ability to minimize the environmental impact
FACILITY OVERVIEW