Medicilon's Pharmaceutical Research services: Process chemistry and Formulation services

2022-03-24

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Medicilon's pharmaceutical research links clinical candidate compounds with commercialized medicine. By developing and improving APIs (Active Pharmaceutical Ingredients) and formulations, we provide our clients with a comprehensive process and quality control system that is both innovative and GMP-compliant.

Process chemistry

Process chemistry generally refers to the design and development of synthetic routes that are safe, cost-effective, environmentally friendly, and efficient.Medicilon's process chemistry department specializes in process development and optimization, production, and project declaration for innovative drugs, generic APIs, and drug intermediates.

Our GMP drug substrate pilot plant is China-US dual filing compliant.

Focusing on pre-clinical pilot synthesis, process development, and commercial production, our services can cover the entire enterprise supply chain, from R&D and procurement to production, whether it's in grams or kilograms, our production scalability is flexible to accommodate our clients changing needs, allowing us to provide highly customizable process research services.

Starting from process design QBD, we integrate our rigorous analysis and quality control services throughout our client's projects, including:

• Development and erification of analytical methods

• Separation and identification of impurities

• Metal ion impurity studies

• Genotoxicity studies

• API salt and crystal pattern studies API

• Stability tests and more

In addition, Medicilon strongly emphasizes chemical safety in our research services. We own a safety assessment laboratory that enables us to guarantee the chemical safety of our design processes, while effectively promoting the environmental safety of our chemical processes.

However, our pursuit of green chemistry doesn't stop there, in the API development process we have vigorously developed enzyme chemistry photoredox reactions, continuous reactions, and more to minimize future environmental impact and ensure the safety and economic sustainability of our client's projects.

Formulation

We are committed to offering our clients integrated and systematic formulation research services, including:

• Project feasibility evaluations

• Pre-formulation

• Formulation studies

• Quality control studies

• Clinical sample production

• Stability studies

• Registration and IND filing

Medicilon's GMP Drug Products Pilot Plant can meet the production and storage needs of phase one and phase two clinical samples.Our state-of-the-art laboratory equipment includes:

• Hot melt extrusion machines

• Spray dryers

• Wet granulators

• Dry granulators

• Pulverizers

• Granulators

• Multifunctional fluidized beds

• Mixers

• Tablet presses

• Capsule filling machines

• High-efficiency coating machines

• Blister packaging machines， and more

Medicilon's-Pharmaceutical-Research-labs.jpg

Medicilon's Formulation department is dedicated to developing innovative insoluble drugs, By utilizing our seasoned technologies for solid dispersion、 micronization, solubilization， clathrate compound formation， and in vitro dissolution/in vivo pk evaluation.

We have helped our clients solve common solubility and permeability problems in new drug candidate compounds.

We are also dedicated to high-end formulation technology, with experience in:

• Inhalation administration

• Ophthalmic administration

• Transtermal administration

• Sustained end controlled release administration

• New particle system administration

Medicilon continues to innovate and improve our technical services to meet our client's diverse needs. To maintain optimum project quality and data integrity, we have established a detailed end-to-end SOP quality system that we follow without deviation.

From project kick-off to results delivery, we closely monitor and control the entire formulation process.

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