DEVELOPMENT SERVICES
Drug Substance
MediXpress offers extensive process development capabilities to meet the drug substance production requirements of our clients across various stages of preclinical and clinical development. We employ cutting-edge technologies to address the increasing demand for small-scale drug substance manufacturing, providing key starting materials (KSMs) of both non-GMP and GMP grades, advanced intermediates, and active pharmaceutical ingredients (APIs) in quantities ranging from laboratory-scale to industrial-scale production.
Drug Product
In the past two decades, drug delivery systems have evolved significantly, driven by rigorous scientific collaboration across diverse fields such as biology, chemistry, engineering, and pharmaceutics. At MediXpress, we collaborate closely with our clients to develop the most suitable formulation for their molecules, considering their physicochemical and biopharmaceutical properties. Our formulation solutions range from preclinical and first-in-human (FIH) dosage forms to optimized drug products for late-stage development and commercialization.
Our formulation expertise is backed by advanced facilities, including high-throughput screening and automated formulation platforms.
We offer pre-formulation studies, drug-excipient compatibility assessments, process optimization, and ensuring a seamless transition from laboratory development to large-scale manufacturing. At MediXpress, we are dedicated to delivering top-tier drug delivery solutions to advance the development of life-saving therapies.
Our dedicated scientific team at MediXpress is committed to addressing challenges related to solubility, in vivo exposure, solid forms, and stability, assisting in the development of challenging therapeutic compounds from preclinical stages to market readiness, tailored to your specific needs. We leverage various drug delivery systems to enhance drug bioavailability, achieve targeted delivery, and prolong drug release.
Analytical Method Development & Validation
At MediXpress, our commitment to producing high-quality drug substances includes providing essential data for regulatory approval. Our analytical laboratories are equipped with a wide range of cutting-edge technologies, enabling precise assessments and characterizations of drug substances. This ensures that the compounds we develop adhere to stringent quality and purity standards set by regulatory bodies like the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
To maintain efficiency and cost-effectiveness, we develop and validate methods tailored to each stage of development. Our analytical sciences team collaborates closely with process chemists to establish robust methods that support the development process. We specialize in identifying and quantifying impurities in drug substances, ensuring the final product’s purity and safety.
Quality control analytical testing of active pharmaceutical ingredients is conducted using state-of-the-art, GMP-qualified equipment and facilities. Our experienced scientists and analysts are committed to delivering accurate and reliable results to our clients.
Process R&D
MediXpress’s process R&D team is well-equipped to develop and scale up manufacturing processes in our state-of-the-art plant facilities, supporting production from milligrams to tons for commercial purposes.
Our advanced plant facilities empower our process R&D team to design and scale up manufacturing processes efficiently. Our objective is to identify and develop robust, cost-effective, and environmentally friendly processes for chemical compound and product manufacturing. This involves optimizing chemical reactions, refining purification, isolation techniques, developing and validating analytical methods to monitor and control the processes.
We prioritize the production of high-quality products with consistent quality and purity while minimizing impurity or contaminant risks. This involves testing and optimizing processes at small laboratory scales before scaling up to pilot and production scales.
Our range of services includes
1. Process development and optimization
2. Analytical method development and validation
3. Impurity profiling and trace analysis
4. Scale-up and manufacturing support
5. GMP manufacturing
We closely collaborate with our clients to ensure their specific needs and requirements are met, providing flexible and customized solutions tailored to their unique needs.
Custom Synthesis
At MediXpress, we recognize that custom synthesis is a crucial service that aids our customers in developing and expanding their product portfolios. Our team specializes in supplying specific molecules in accordance with customer processes and requirements, with a focus on maintaining purity throughout the synthesis process.
Leveraging the expertise of our custom synthesis specialists, customers gain access to a wider range of products, allowing for diversification of their product offerings, enhanced product performance, and an expanded customer base. This facility helps customers overcome challenges in product development,
such as yield improvement, purity enhancement, or the development of more cost-effective and environmentally friendly processes.
Our team closely collaborates with customers to understand their unique requirements and tailors the synthesis process accordingly. We excel in complex molecule synthesis, including those requiring specific stereochemistry or facing solubility or stability challenges.
At MediXpress, our commitment is to deliver high-quality, customized synthesis services that align with our customers’ needs, whether they require a specific compound for research purposes or need to scale up production for commercial use.
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