- Management of contract manufacturing organizations and contract laboratories
- Experience and support with vendor selection activities
- Guidance with technical transfer of chemical processes
- Route selection and route evaluation
- Guidance on selection and justification of regulatory starting materials
- Process validation and continuous process verification experience
- Implementation of Quality by Design
- Help designing studies to characterize PARs and NORs
- Criticality assessment
- Performing or facilitation of technical risk assessments
- Guidance with potential mutagenic impurity control strategies
- Technical report writing, reviewing, and editing
Transforming Concepts into High Quality Active Pharmaceutical Ingredients (API)
- We at CMC Techops realize that the development of drug substances is the cornerstone of any successful successful pharmaceutical product. By employing our custom approach, combining cutting-edge scientific expertise with cutting-edge technology and a commitment to the most stringent regulatory compliance, our company delivers high-quality Active Pharmaceutical Ingredients (APIs) to the highest global standards. With over 35 years of experience, we offer solutions for large or small molecules, from methods and synthesis to extraction and scalable CGMP production.
Our Approach to Drug Substance Development
- Specifically, we rely on a detailed development process to assure the reliability, purity, and effectiveness of each one of the APIs. We combine advanced technologies and methodologies to ensure the solutions we bring are scalable, in line with industry standards and address the project’s uniqueness.
Key Capabilities in Drug Substance Development
- Process Development and Optimization: We refine synthesis routes through a series of iterative experiments to develop efficient, reproducible and high throughputs with high yield and purity while minimizing waste. With this, we carry out our process optimization focusing on the analysis of reaction kinetics, profiling of impurities, and crystallization studies to ensure the stability and consistency of the product.
- Analytical Development: Comprehensive analytical testing is a key aspect of what we undertake in our drug substance development services. All of our system contains advanced instrumentation such as high-performance liquid chromatography (HPLC), mass spectrometry and nuclear magnetic resonance (NMR) spectroscopy to verify the identity, purity and potency of each API. We also perform method validation and impurity profiling as well as stability testing to meet regulatory requirements.
- Polymorph Screening and Crystallization: The polymorphic form of an API can influence greatly solubility, stability and bioavailability. We specialize in our polymorph screening services: we assess crystallization parameters to find the best form for your drug product. Solid-state characterization is performed with XRPD, DSC and TGA.
- Impurity Control and Removal: Throughout the numerous stages of the synthetic process, impurities can come and often they cannot be controlled and therefore must be kept low for regulatory compliance. In particular, we have defined an extensive impurity control strategy with in-depth identification, qualification, and quantification of process-related and degradation impurities. Moreover, we implement techniques that allow you to remove any targeted molecules from your API to keep it under strict purity standards.
- Particle Engineering: Particle size and morphology can affect manufacturability, stability and bioavailability of an API. Our physical properties capabilities include milling, micronization, and spray drying so that we can tailor the physical properties of your API to meet your formulation requirements. Laser diffraction and dynamic light scattering are applied to monitor particle size distribution for batch-to-batch consistency.
Why Choose CMC Techops for Drug Substance Development?
- Deep Scientific Expertise:
We have a very talented team with an extensive background in both chemistry and biology and engineering of developing drug substances. To stay at the top of the industry, we use the most cutting-edge technology and methodologies.
- Customized Solutions:
We style your API development based on your requirements and make your project a success. We work with you on molecule synthesis or biologics processes to develop efficient scalable solutions.
- Advanced Infrastructure:
Through our state-of-the-art CGMP facilities, we can scale our projects up and down to provide flexibility and we handle everything from small to large and complex projects. We’re set up to work with you — from your pilot scale production through to commercial manufacturing — to help you advance your API development.
- Commitment to Quality and Compliance:
Through strong quality assurance and regulatory compliance systems, we provide every part of our drug substance development works with the greatest industry standards. We know quality delivery means a commitment to you that your API will meet the most rigorous standards of the global markets.