Active Ingredient CDMO

Route Scouting :

Biotalk experienced chemists will first seek to establish historical process work and conduct searches of scientific literature to identify synthetic route options. These options are then presented to clients in priority order, highlighting the key benefits of each. Following a phase of laboratory work to assess the on-paper routes, one or two will be selected for further, more detailed laboratory assessment and optimization. The final route choice to move into more formal development is made in conjunction with the client and based on number of criteria. Establishing the best synthetic route is the basis for a reliable supply throughout the product’s life cycle. the following considerations are important when selecting the optimal pathway:

■ Safety

■ Efficiency, purity and costs

■ Ease of optimization and scale up

■ IP review

■ Security of supply of raw materials

■ Impact on waste and the environment

■ Physical characterization

Home ꄲ Active Ingredient CDMO

Process Development & Validation：

Process management team has deep chemical engineering knowledge and many years fine chemical process development and validation experience such as selection of process route, start material, intermediate control, impurity control, key route and parameter confirmation, critical quality control point and risk assessment, continuous following-up and upgrade in full life cycle of process validation( process design, process confirmation, continuous process confirmation)

Our core competencies include:

■ Process optimization and development

■ Rapid scale up from laboratory to support early phase activities

■ Tech transfer and scale up of existing processes

■ Process validation

■ Full regulatory support

■ Expertise with structurally complex and difficult-to-manufacture

Scale up & commercialization ：

Professional fine chemical production project management team focus on scale up, equipment selection &installment, systematic production procedure setup and application, safety &environment protection system design and maintenance, compliance requirement, raw material supply and quality control, then every project will complete on time to deliver high quality and high yield outcome, meanwhile, continuous process improve will increase output and reduce lead-time, our commercial batch production capability include:

■ Scale from grams to kilos to tonnes

■ Early and late phase facilities & equipment selection and installment

■ Comprehensive production safety management

■ Establishment of production procedure &operation instruction

■ Environment protection system design & setup

■ Extensive sourcing network for starting materials and advanced intermediates

■ Full regulatory support in production

Production Management：

Preparing detailed manufacturing management info for every product to be produced, ensure smooth process in manufacturing, continuous improvement to optimize the production parameter for the most effective result in scale up and commercialization.

■ PID

■ Manufacturing Flow Chart

■ SOP& Operation record

■ Analytical procedure for in-house and finished product

■ Work unite operation time sheet

■ Raw material MSDS and safety notice

■ Waste treatment Solution

Quality control & analytical service ：

Raw material and intermediates quality and quality test in process is critical to qualified product, in supporting route scouting and process development, we provide comprehensive chemical analysis service ,our quality control and analytical team have extensive experience and range of state-of-the-art test technology below:

■ Development and validation analytical methods

■ Analytical method transfers

■ Impurity tracking, isolation and identification

■ Reference standard characterization

BIOTALK CO.LTD

Excellent in quality&technology， fruitful world we generate globally

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