Process Development
Process development plays vital role in the manufacture of APIs (NCEs and generic).
Sambi Pharmaceutical’s fully-equipped process research and development lab allows rapid development of scalable and robust chemical processes utilizing advanced methodologies. Sambi Pharmaceutical is also equipped with a kilo lab for a quick supply in the early phase of the development.
Our top notched scientists are experts to develop the robust process using PROCESS principles such as Proven, Repeatable, Owner driven, Compatible, Executable, Sustainable, Successful and also SELECT principles such as Safety, Environment, Legal, Economics, Control and Throughput. Our scientists are also experts to develop the sustainable process using GCbD (Green Chemistry by Design).
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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Our Lab Images
Our Service Offerings
Our Team Offers:
- Early phase process development.
- Late phase process development.
- Commercial scale process development.
- API process development.
- Life cycle management.
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Contact
4953 Vine Street
San Diego, CA 92465
815.555.5555
info@sambipharma.com