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Medicilon’s Pharmaceutical Process Optimization Service

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Medicilon’s professional R&D team has rich experience and ability to use sufficient resources, complete production equipment and advanced production facilities, as your long-term strategic partner, to provide customers with high efficiency and maximize production capacity services, saving customers Time and cost to produce reliable and cost-effective intermediate and API products for you. The main R&D projects include: chemical drug synthesis process optimization, preparation process optimization, etc.

Pharmaceutical process optimization

The process R&D department is committed to developing stable and low-cost processes suitable for mass production. Our R&D team has extensive experience in optimizing processes and developing new, safe and environmentally friendly process routes.

The process development project team has extensive experience in the following research directions:

Screening of commercial routes

Development and optimization of commercial processes through reaction design (DoE) and quality design (QbD)

Unit operation research and confirmation of key process parameters of each step

 Research on the structure, source and control of impurities

Definition of GMP starting materials

One-stop service

We have a complete “one-stop” process development and API production capacity, which can ensure the smooth transfer of process technology and production scale, and realize the project from the pre-clinical smooth stage to the commercial stage.

The optimization of drug synthesis process is an improvement and innovation based on the existing drug synthesis process, including the selection of the best process conditions (parameters, solvents, additives, etc.), the optimization of post-processing methods and the overall innovation of the process. The sum of research work.

The goal of drug synthesis process optimization

1. Improve quality: including increasing content, reducing impurities, improving appearance and color, improving fluidity, increasing shelf life, etc.;

2. Cost reduction: including improving yield, replacing raw materials, shortening reaction cycle, recovering solvent, etc.;

3. Improving large-scale production capacity: refers to the optimization of increasing production capacity under the existing production process conditions, including batch adjustment, fine-tuning of large-scale process parameters, etc.;

4. Reducing waste emissions: refers to the optimized treatment of the three wastes <gas-liquid-solid>, including the absorption of waste gas, the recovery of waste liquid, and the use of waste residue;

Steps and methods for pharmaceutical process optimization

1. Small trial stage: optimize route, ensure quality, and ensure supply;

2. Pilot stage: equipment is more expensive and needs to be optimized into a reasonable and stable process; raw material costs may be relatively high and need to be optimized to achieve the expected output; low yields and low yields may affect the production plan of intermediates and products;

3. Optimization at the production stage: optimization of process details should not cause major changes to routes, parameters, and methods.

Optimization of synthetic route: Do not optimize route unless there is sufficient evidence to prove that the current route cannot obtain the expected results.

Optimization of drug reaction parameters: screening methods for temperature, time, molar ratio, solvent, stirring, etc.

Research Approach of Chemical Technology

Determine the route

a. Selection of chemical reaction type

b. Synthesis steps and total yield

c. Reaction of raw and auxiliary materials

d. Replacement of raw and auxiliary materials and synthesis steps

e. Order safety assessment of unit response

f. Technical conditions and equipment requirements

g. Safe production and environmental protection

Process influence factors

a. Reactant concentration and batching ratio

b. Reaction temperature and pressure

c. Catalyst

d. Stirring

e. Control of reaction time and end of reaction

f. Quality control of raw materials and intermediates

Determine process parameters

a. Single factor parallel test optimization method

b. Multi-factor orthogonal design optimization method

c. Multi-factor uniform design optimization method

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Phone: 02158591500

The above content is about pharmaceutical process optimization, pharmaceutical process optimization, chemical synthesis process optimization, etc., which comes from the Medicilon official website.

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