Central nervous system (CNS) diseases encompass a variety of conditions that impair the brain’s normal functions, affecting health and daily activities. These diseases can stem from genetic disorders, infections, strokes, tumors, or sometimes unknown causes. Common CNS conditions include movement disorders like Parkinson’s disease, dystonia, and essential tremor, all of which involve the loss of critical nerve circuits responsible for functions such as memory and movement.

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Our CNS Drug development Expertise

Our expert formulators and material scientists are skilled in nanoengineering drugs to perform functions like transference across the BBB, altering signaling pathways, targeting specific cells, effective gene transfer, and promoting regeneration and preservation of nerve cells. Moreover we have the equipment to manufacture and supply nanoparticle therapeutics across all scales from preclinical to commercial.

We are committed to accelerating the development of new medicines for patients worldwide. As a unique drug development and manufacturing accelerator that combines drug development, clinical testing, and manufacturing, we can tackle the challenges that our customers entrust us with, to develop drug programs, fast.

CNS/Neurology Formulation Development

While many CNS diseases cannot be fully cured, their symptoms can often be managed with therapies and new medications. However, treatment success rates have been historically low, primarily because many drugs fail to reach their intended targets in the body. The blood-brain barrier and other protective systems in the CNS can block the effective distribution of these drugs.

Nanotechnology, which has made significant strides in the last decade, holds great promise for overcoming these challenges. By using nanoparticles, it’s possible to deliver drugs more effectively to the affected areas of the brain. This innovative approach could revolutionize the treatment of neurological disorders, offering new hope for managing these complex diseases.

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Here are some frequently asked questions about Analytical Services

What Analytical Services Do CDMOs Offer?

 CDMOs offer a wide range of analytical services to support pharmaceutical development and manufacturing. These services include but are not limited to method development and validation, stability testing, impurity profiling, dissolution testing, and raw material testing. Advanced analytical capabilities such as high-performance liquid chromatography (HPLC), gas chromatography (GC), mass spectrometry (MS), and nuclear magnetic resonance (NMR) spectroscopy are utilized to ensure precise and accurate analysis of pharmaceutical products.

Why Are Analytical Services Important in Pharmaceutical Development?

Analytical services are crucial in pharmaceutical development for ensuring the safety, efficacy, and quality of drug products. They provide essential data on the chemical composition, stability, and potency of pharmaceuticals, which is critical for regulatory submissions and compliance. Analytical testing helps in identifying and quantifying impurities, validating the manufacturing process, and ensuring that the final product meets the specifications and standards set by regulatory authorities.

What Is Method Development and Validation?

Method development and validation are processes used to ensure that an analytical method is suitable for its intended purpose. Method development involves designing a test that is accurate, precise, specific, and reproducible for analyzing a particular pharmaceutical product or component. Validation is the process of demonstrating that the method consistently produces reliable results within specified limits. It includes assessments of accuracy, precision, specificity, linearity, range, and robustness of the method.

How Is Stability Testing Conducted?

Stability testing is conducted to evaluate how the quality of a drug substance or drug product varies with time under the influence of environmental factors such as temperature, humidity, and light. The testing involves storing the product at specified conditions and testing it at predetermined intervals to assess physical, chemical, and microbiological stability. This testing is critical for determining shelf life, storage conditions, and packaging requirements.

Can CDMOs Provide Regulatory Compliance Support?

Yes, CDMOs can provide comprehensive regulatory compliance support as part of their analytical services. This includes generating data and documentation needed for regulatory submissions, such as Investigational New Drug (IND) applications, New Drug Applications (NDA), and Abbreviated New Drug Applications (ANDA). CDMOs stay updated on regulatory guidelines and requirements to ensure that analytical testing and documentation meet the standards of regulatory bodies like the FDA and EMA.

What Is Impurity Profiling?

Impurity profiling is the identification, quantification, and analysis of impurities in drug substances and products. It is crucial for ensuring the safety and efficacy of pharmaceuticals. Impurities can arise from various sources, including raw materials, synthesis processes, degradation, and interactions with packaging. CDMOs use sophisticated analytical techniques to detect and characterize these impurities, ensuring that they are within acceptable limits.

How Do CDMOs Ensure Data Integrity in Analytical Services?

CDMOs ensure data integrity by adhering to Good Laboratory Practices (GLP) and following strict standard operating procedures (SOPs) for all analytical testing. Data integrity measures include using validated analytical methods, calibrating instruments regularly, training personnel thoroughly, maintaining detailed records of all tests and results, and using secure data management systems. Regular audits and quality checks are performed to ensure compliance with data integrity principles.

Are CDMOs Equipped to Handle Highly Potent Compounds?

Yes, many CDMOs are equipped with specialized facilities and equipment to safely handle highly potent compounds. These include containment systems and dedicated labs designed to protect personnel and prevent cross-contamination. CDMOs have expertise in developing and validating analytical methods for highly potent compounds, ensuring accurate and safe handling throughout the analytical process.

Can CDMOs Support Formulation Development with Analytical Services?

Absolutely, CDMOs play a crucial role in supporting formulation development with their analytical services. They provide critical data on the compatibility of drug substances with excipients, the stability of formulations, and the optimization of formulation processes. Analytical services such as dissolution testing, content uniformity testing, and release rate profiling are integral to developing effective and stable pharmaceutical formulations.

How Do CDMOs Stay Ahead in Analytical Technologies?

CDMOs stay ahead in analytical technologies by continuously investing in the latest analytical instruments and software, training their personnel in cutting-edge methodologies, and staying abreast of scientific and regulatory developments. They collaborate with technology providers, participate in industry conferences, and contribute to research and development efforts. This commitment ensures they can offer advanced and efficient analytical services to meet the evolving needs of the pharmaceutical industry.