Route Scouting Services
At Sambi Pharma, we offer a range of route scouting services tailored to meet the unique needs of our clients:
Literature Review and Analysis:
Our team conducts extensive literature reviews to identify existing synthesis routes and evaluate their feasibility and efficiency. By leveraging our expertise and access to diverse scientific databases, we provide clients with valuable insights into established methodologies and potential optimization opportunities.
Computational Modeling and Prediction:
Using state-of-the-art computational tools and software, we employ molecular modeling and simulation techniques to predict and optimize synthesis routes. Our computational approach enables rapid exploration of reaction pathways, facilitating the identification of the most promising routes for further experimentation.
Experimental Route Screening and Optimization:
Through practical experimentation in our advanced laboratories, we validate theoretical predictions and optimize synthesis conditions. Our experienced chemists conduct route screening studies, optimization experiments, and scale-up trials to identify robust and scalable routes for API production.
Regulatory Support and Compliance:
We provide comprehensive regulatory support to ensure compliance with global quality and safety standards. Our team assists clients in navigating regulatory requirements, addressing potential challenges, and preparing documentation for regulatory submissions.
Intellectual Property (IP) Assessment:
With a keen focus on IP considerations, we conduct thorough assessments to identify potential infringement risks and opportunities for innovation. By collaborating with clients to develop IP strategies, we help safeguard their intellectual property and mitigate legal challenges.
Lab Services:
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- Synthesizing NCEs
- Library Synthesis for LI N LO Projects
- Our Business Model Includes FTE n FFS Hybrid Models, Long term Multiyear contract and continuous material supply support.
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Our Expertise in handling:
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- Heterocycles
- Chiral Chemistry – Chiron & Asymmetric synthesis
- Unnatural amino acids
- Small peptides: Solution phase up to hexamers
- Carbohydrates & Aza sugars
- Nucleoside building blocks
- PROTAC Chemistry
- ADC Linkers
- PEG- Lipids
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Analytical chemistry:
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- Data analysis & interpretation
- Method development & validation
- Reporting the results & documentation
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Quality Assurance and Quality Control:
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- At Sambi Pharma, utmost importance is given to Quality than business profits. With our quality culture across the company, we have built a remarkable reputation with clients.
- Every member of our team is equally committed to delivering zero-defect products on time, and as promised to our customers.
- The Principles of the Quality Management System adopted by the company are as per ISO 9001:2015 guidelines.
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Process R&D & Manufacturing:
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- Chemical Synthesis – Route proposal, Selection and Synthesis
- Process Development – Reaction optimization, Scale up studies, Product purification, Safety studies, Quality control, Process validation and Technology transfer.
- Scale up & Manufacturing: Synthesis of Advanced API intermediates and KSM (Key Starting Material) from KG-MT Scale.
- Loan licensed GMP/Non-GMP plants to offer commercial manufacturing activities.
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Our In- House Pilot Plant Includes:
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- 100 L 200 L 500 L glass reactor with Heating/cooling system: –70°C to +150°C
- 20 L high vacuum distillation unit
- Pressure Nutsche filter, centrifuge
- Autoclave ranging from 100ML – 25 L
- Rotavapors ranging from 2L – 20 L
- Vacuum Tray dryer
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Why Choose Sambi Pharma?
- Expertise and Experience: Our team comprises seasoned chemists and pharmaceutical experts with extensive experience in route scouting and API development.
- Innovation and Technology: We leverage cutting-edge computational tools and laboratory facilities to deliver innovative solutions and accelerate drug discovery.
- Collaborative Partnership: We prioritize client collaboration and communication, working closely to understand their specific requirements and deliver customized solutions.
- Quality and Compliance: Our commitment to quality and regulatory compliance ensures the delivery of reliable and compliant route scouting services.
- Confidentiality and Integrity: We uphold the highest standards of confidentiality and integrity, safeguarding our clients’ proprietary information and interests.
- Discovery
- Early Phase Development
- Late Phase Development
- Commercial API
- APIs
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Contact
4953 Vine Street
San Diego, CA 92465
815.555.5555
info@sambipharma.com
Choose Sambi Pharma as your trusted Route-Scouting Partner.