Target validation is a crucial step in the drug discovery process where the biological target for a potential new drug is confirmed to have a key role in the disease process. This involves various techniques such as genetic studies, functional assays, and animal models to demonstrate the target’s significance. By validating the target, researchers can ensure that efforts to develop a drug against it are more likely to succeed.
Hit identification is the stage where potential drug candidates are identified as having the desired biological activity against the validated target. This involves high-throughput screening of compound libraries or using computer-aided drug design to identify molecules that show promise in interacting with the target. Hits are typically identified based on their potency, selectivity, and other pharmacological properties.
Lead optimization involves the refinement of hit compounds into lead compounds that possess improved drug-like properties. This process aims to enhance the potency, selectivity, pharmacokinetic profile, and safety of the lead compounds. Medicinal chemistry techniques are often used to modify chemical structures and properties to optimize the lead compounds for further development.
Preclinical development encompasses the early stages of drug development where the efficacy and safety of lead compounds are assessed in laboratory and animal studies. This stage involves pharmacology, toxicology, and ADME (absorption, distribution, metabolism, and excretion) studies to understand the compound’s behavior in biological systems before advancing to clinical trials.
Formulation development is the process of designing a dosage form that ensures the safe and effective delivery of the drug compound to the patient. This includes selecting excipients, optimizing drug release characteristics, and creating formulations suitable for administration routes such as oral, injectable, or topical.
Analytical development involves the establishment of methods and techniques to analyze the quality and purity of drug compounds throughout the development process. This includes methods for quantifying the concentration of the drug, identifying impurities, and ensuring consistency in manufacturing. Analytical methods play a crucial role in meeting regulatory requirements and ensuring product quality.
Small molecule API manufacturing involves the production of active pharmaceutical ingredients (APIs) that are chemically synthesized and have a low molecular weight. This process typically includes chemical reactions, purification, and crystallization to obtain the final API in a form suitable for drug formulation.
HPAPI manufacturing is focused on producing APIs that are highly potent and require stringent containment measures due to their toxicity. These compounds are typically used in oncology and other therapeutic areas where precise dosing is critical. HPAPI manufacturing facilities have specialized equipment and controls to ensure worker safety and product quality.
Natural product API manufacturing involves the extraction and purification of active ingredients from natural sources such as plants, marine organisms, or microorganisms. These natural products often have complex chemical structures and may require specialized extraction and purification techniques to obtain the API in a pure and stable form. Natural product APIs are used in various therapeutic areas and are of growing interest in drug discovery.
Aseptic fill and finish is a critical step in the pharmaceutical manufacturing process, ensuring that drug products are prepared and packaged in a sterile environment to prevent contamination. AMRI offers comprehensive aseptic fill and finish services, utilizing state-of-the-art facilities and equipment to meet the highest quality standards. From filling vials and syringes to lyophilization and terminal sterilization, AMRI’s aseptic fill and finish capabilities encompass a wide range of drug product forms.
AMRI specializes in the manufacturing of oral solid dosage forms, such as tablets and capsules, using advanced technologies and processes to ensure precision and consistency in drug product manufacturing. With a focus on quality and compliance, AMRI’s oral solid dosage form manufacturing facilities adhere to strict regulatory requirements to deliver safe and effective medications to patients worldwide.
Sterile liquid and lyophilized products require specialized manufacturing processes to maintain product stability and integrity. AMRI’s sterile liquid and lyophilized product manufacturing capabilities encompass formulation development, aseptic processing, and lyophilization to produce high-quality injectable medications. With expertise in sterile product manufacturing, AMRI ensures that products meet stringent regulatory standards and provide optimal patient outcomes.
Method development and validation are essential aspects of pharmaceutical analysis, ensuring that analytical methods are accurate, reliable, and reproducible. AMRI’s analytical services include method development and validation, utilizing state-of-the-art instrumentation and experienced scientists to establish robust analytical methods for drug product testing. By performing method validation according to regulatory guidelines, AMRI ensures the quality and integrity of analytical data for drug development and manufacturing.
Stability testing is a crucial component of drug product development, assessing the chemical and physical stability of pharmaceutical formulations over time. AMRI offers comprehensive stability testing services, including accelerated and long-term studies, to evaluate the stability of drug products under various storage conditions. By conducting rigorous stability testing, AMRI helps pharmaceutical companies ensure the quality and shelf-life of their products.
Impurity profiling is an important aspect of drug product analysis, identifying and characterizing impurities present in pharmaceutical formulations. AMRI’s analytical services include impurity profiling, utilizing advanced analytical techniques to detect and quantify impurities in drug products. By providing detailed impurity profiles, AMRI supports pharmaceutical companies in optimizing their manufacturing processes and ensuring product quality and safety.
Regulatory filings are a critical step in bringing pharmaceutical products to market, requiring comprehensive documentation and adherence to regulatory requirements. AMRI offers regulatory support services for drug substance and drug product filings, assisting clients in preparing and submitting regulatory dossiers to health authorities. With expertise in regulatory requirements, AMRI facilitates the regulatory approval process and helps clients navigate complex regulatory landscapes.
Quality assurance and compliance are essential components of pharmaceutical manufacturing, ensuring that products meet quality standards and regulatory requirements. AMRI’s quality assurance and compliance services encompass GMP auditing, quality control testing, and compliance monitoring to uphold the highest quality standards in drug manufacturing. By implementing robust quality systems, AMRI helps pharmaceutical companies maintain compliance and accelerate product development timelines.
After-market support is crucial for ensuring the continued quality and safety of pharmaceutical products after they have been commercialized. AMRI provides after-market support services, including post-marketing surveillance, product quality monitoring, and regulatory compliance assistance to support products throughout their lifecycle. By offering comprehensive after-market support, AMRI assists pharmaceutical companies in maintaining product quality and regulatory compliance over time.