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GMP API Development

Service overview

GMP API Development

Elixierlife specializes in Early Phase API Development.

Producing clinical batches for innovative APIs shares many elements with GMP API development but diverges in key aspects. The primary aim is to manufacture a limited quantity of novel API for early-phase human clinical trials, focusing on evaluating safety, efficacy, and tolerability.

The starting point is usually an existing lab-scale proof-of-concept technology that has undergone validation through animal or in vitro studies. This stage serves as a crucial link between preclinical research and full-scale API development, guiding future strategies based on data from human trials.

Elixierlife is well-equipped to handle the specific needs of clinical Phase API development and offers facilities that accommodate lower pilot-scale production volumes.
  • Route Scouting
  • Process Optimization & Scale-up
  • Analytical Development

Route Scouting

At Elixierlife, our route scouting process is meticulously designed to identify the most efficient and cost-effective synthesis pathways for a given compound. This involves a comprehensive evaluation of multiple chemical routes to determine the optimal synthesis approach. Additionally, route scouting leads to the preliminary development of analytical methods necessary for assessing starting materials, reagents, and products in subsequent development stages.

Whether we’re working with innovative molecules that demand novel synthesis methods or older generics, route scouting plays a critical role in establishing the foundation for a robust and economically viable manufacturing process. By conducting thorough route scouting, we ensure the development of high-quality APIs that meet the stringent standards of safety, efficacy, and regulatory compliance.

At Elixierlife, our process development activities entail a meticulous series of steps to develop and control process parameters while scaling up operations. Purification optimization is a crucial aspect of our efforts, targeting the enhancement of API purity and quality enhancement. Our team focuses on developing process parameters such as temperature, pressure, and reaction times to maximize yield and uphold stringent quality standards. We provide comprehensive analytical support to ensure reliability and consistency throughout the scaling-up process.

These stages are fundamental for validating and preparing the process technology before transitioning to larger batch sizes. Typically, the preliminary process development culminates in the creation of a representative technical batch that meets the required technical specifications.

Once the optimal process parameters have been identified and validated at the laboratory scale, we move towards scale-up. This involves gradually increasing the batch sizes while maintaining the integrity of the process and ensuring that the quality of the API remains consistent. Our team carefully monitors the scale-up process to identify and address any potential challenges or deviations that may arise.

The culmination of this process is the successful production of a representative technical batch that meets all the required technical specifications. This batch serves as a validation of the scaled-up process and provides confidence in the ability to produce the API at larger scales while maintaining the highest standards of quality and consistency.

Overall, our approach to process optimization and scale-up at Elixierlife is characterized by meticulous attention to detail, rigorous experimentation, and a commitment to delivering APIs of the highest quality to our clients.

At Elixierlife, our analytical development process in API manufacturing is meticulously designed to validate testing methods for starting materials, intermediates, and the final API product. These methods are instrumental in monitoring key parameters to ensure consistent reaction behaviour and uphold the highest standards of product quality and safety.

Our primary objective is to ensure the quality and safety of all compounds used or produced during the manufacturing process. For process reagents and intermediates, our standard activities include comprehensive analytical method development and validation. Additionally, our process involves the synthesis and characterization of impurities, qualification of reference materials, and stringent control of potentially genotoxic impurities.

The final development of the API necessitates a comprehensive battery of tests and validations to confirm its quality, purity, safety, and efficacy. These encompass a wide range of activities, including API assay validation, testing for related substances, verification of residual solvents, analysis of water content, forced degradation studies, microbiological tests, endotoxin assessment, limit of detection (LoD) determination, powder X-ray diffraction (PXRD), photostability evaluation, assessment of mutagenic impurities, particle size distribution (PSD) analysis, chiral high-performance liquid chromatography (HPLC), optical rotation measurement, analysis of specific impurities, melting point determination, and testing of counter-ions, among others.

These meticulously executed analytical development activities are an integral part of our robust quality assurance mechanism, ensuring that our API manufacturing processes consistently meet the highest standards of quality, safety, and efficacy.