Analytical development (AD)

Familiarization:

• Analytical method implementation 
  Implementing of analytical methods in the laboratory environment is a significant aspect of our operations.  
  
  We prioritize the formal transfer of analytical methods, adhering to stringent GMP processes. Through comprehensive documentation and laboratory qualification, our highly qualified staff ensure the reproducibility and robustness of complex methods in our environment.  These accurate procedures underscore our commitment to maintaining the accuracy and reliability of analytical methods, essential for upholding pharmaceutical quality and regulatory standards. 

Development:

• Development of analytical methods  
  At our pharmaceutical facility, we take immense pride in our development of analytical methods spanning every stage of drug development, from raw starting materials to final products. These methods are the backbone of our commitment to quality management and maintaining the highest standards throughout the pharmaceutical industry. Our goal is clear: to craft methods perfectly suited to their intended purpose, we guarantee the reliability and effectiveness of our analytical methods in the laboratory empowering us to consistently deliver pharmaceutical products of unparalleled quality, safety, and efficacy. 
  
  

• Starting materials, intermediates and APIs characterization 
  Characterization of substances stands as a pivotal aspect of development, ensuring our products meet the highest standards for safety, efficacy, and quality. With a focus on chemical and physical attributes, we methodically characterize starting materials, intermediates, and APIs using advanced analytical techniques This steadfast commitment to characterization underpins our dedication to delivering pharmaceutical products of uncompromising quality and efficacy. 
  
  
• Optimization of generic methods  
  In addition to monitoring the development process, it is imperative to tailor various analytical methods to our specific analyte. Through careful development and optimization, we ensure the accuracy and reliability of these analytical methods, essential for maintaining the highest standards of quality and efficacy in pharmaceutical production. 
  
  

• Conducting stability studies and stability indicating studies (stress testing)  
  
  
• Analytical technical transfer   
  Our documented procedure facilitates the transfer of analytical procedures. We facilitate both external and internal transfers.  
  
  
• Characterization of impurities to understand their origin and potential impact on product quality and safety.   
  In the diligent characterization of impurities, our focus extends to their chemical structure, origin, and potential toxicity, crucial for comprehending their impact on quality and safety. Impurity reference standards play a pivotal role in their identification and quantification. With the implementation of Analytical Quality by Design principles, we ensure the production of high-quality drug substances. Our methods are developed in accordance with analytical quality by design tools, employing risk-based approaches to develop and maintain analytical procedures suitable for evaluating the quality of drug substances. 
  
  
• Screening of methods to separate selectively all (potential) impurities  
  Through systematic screening and evaluation of separation methods, we identify the most effective techniques for selectively separating impurities, thus ensuring the quality and safety of the final API.  
  
  To precisely identify and characterize potential impurities, including degradation products, process-related impurities, and contaminants, we use advanced chromatographic and spectroscopic techniques. Our analytical methods are developed and validated to accurately quantify impurities in drug substances. 
  
  
• Impurity mapping through process development, optimization, and production of demo batches.  
  
  
• Evaluation of potentially mutagenic impurities in collaboration with Process R&D 
  Through careful evaluation of process intermediates and reaction conditions, we uphold stringent standards to minimize or eliminate such impurities, By following these steps, our dedicated R&D team effectively identifies, assesses, and controls mutagenic impurities, reflecting our unwavering dedication to ensuring the safety and quality of our pharmaceutical products. 

Analytical Quality by Design (AQbD):

• ATP, CQA, DOE, MODR 
  This comprehensive approach ensures that our analytical methods are tailored to meet the specific needs of each product, guaranteeing accurate and reliable results throughout the drug development process. We use approaches such as Analytical Target Profiling (ATP), determination of critical quality attributes (CQA) for identification of initial risk assessment and Design of Experiments (DoE) for analytical method development. 
  We implement multivariate design of experiments (DOE) to establish the Method Operating Design Region (MODR) Through this methodology, we ensure the reliability and robustness of our analytical methods, underscoring our dedication to quality and excellence. 
  
  
• in-process control and stability monitoring during process development, optimization, and production of demo batches  
  We maintain strict control over our processes, guaranteeing the consistent quality and stability of our pharmaceutical formulations. Method pre-validation is a vital step undertaken before the full validation study. By conducting this preliminary assessment, we proactively identify and address potential issues, ensuring the reliability and efficiency of our analytical methods. reflecting our commitment to quality and excellence in pharmaceutical drug development analysis.