API Process R&D Platform

The solid-form API screening process is a crucial step in the early development of novel medications. The goal is to discover as many crystal forms as possible and to determine which solid form is best for development. Our company provides its customers with a solids screening platform that strictly complies with the registration guidelines and legal specifications set out by international regulatory bodies.

From preclinical lab-scale testing and process development to commercial production, we meet our customers' needs throughout the supply chain, including R&D, procurement, and manufacturing. Our processes allow flexibility to adapt to our customers' innovative process development and scale-up production.

Our API Process R&D Platform

Our company optimizes API production processes. We apply the QbD concept to API process development and are committed to tailoring the right process route to optimize the API production process and improve product quality and process efficiency.

Our service platform covers the development of API quality standards, the establishment of intermediate control standards, optimization and determination of process parameters, optimization and determination of post-treatment methods, optimization, and determination of purification methods, assessment of process risk levels, process safety evaluation, development of quality standards for raw materials, intermediates and final products, impurity spectroscopy studies, and CTD documentation.

Our API process development steps include:

• Determination of the synthesis route.
• Optimization of process parameters, study of salt structure and crystal structure processes, preparation and calibration of reference products.
• Laboratory process validation.
• Production safety assessment of batches.
• Pilot scale-up production.
• Production of clinical batch samples.

Our API quality study process is as follows:

1. Analytical method development (starting materials, intermediates, APIs, mid-control analysis, preliminary degradation tests).
2. Analytical method validation (using pilot batch samples, if no pilot batch, use safety evaluation batch).
3. Stability study.

• Influence factor study (pre-lab scale is used for pre-influence factor testing).
• Accelerated stability study (6 months).
• Long-term stability study (24 months or 36 months).

Advantages of Our company's API Process R&D Platform

Our company currently has extensive laboratory facilities including R&D labs, non-GMP pilot plant, GMP API plant, analytical testing center, QC lab and microbiology lab. A strong R&D team supports API process development services covering synthesis, analysis, microbiology, and project management.

Our laboratory equipment is complete and technologically advanced. The main equipment includes glass reactor, rotary evaporator, stainless steel reactor, vacuum drying oven, temperature controller, precision filter, 2-in-1 filter, centrifuge, crusher shredder, etc. The main analytical instruments include chromatographic analyzers such as UPLC, HPLC, GC, IC, LC-MS, GC-MS, laser particle size analyzer (PSD), differential scanning calorimeter (DSC), thermogravimetric analyzer (TGA), X-ray powder diffractometer (XRPD), nuclear magnetic resonance (NMR), fourier transforms infrared spectrometer (FT-IR), UV spectrophotometer and inductively coupled plasma mass spectrometry (ICP-MS).

We are committed to the transformation from CRO to CDMO by providing quality products and services through efficient, rapid, problem-solving and proactive communication. We expand the scope of pharmacy services and enhance the capability and level of pharmacy services.

For more information, please feel free to contact us.

It should be noted that our service is only used for research, not for clinical use.