We offer cutting-edge synthesis services trusted by leading research labs and companies worldwide.
Innovative, robust and scalable chemistry is the core strength of Laurus. We support drug development and manufacturing programs for global pharmaceutical and biotech companies at all stages from pre-clinical stage to commercialization. Our development and manufacturing teams maintain a tight focus on performance at scale, continuous process improvement, securing and de-risking supply chains to provide an efficient, compliant, cost-effective and long-term commercial drug substance and drug product solutions.
Laurus is well-positioned to meet all NCE Drug Substance and Drug Product needs of clients, from preclinical through commercial manufacturing. The strong analytical chemistry team at Laurus works with the chemical development and tech-transfer teams to provide necessary phase-appropriate support to clients for their drug substance and drug product analytical development needs. The drug product development team at Laurus is well-equipped to develop all types of formulations both for NCEs, Generics and other specialty products. Our comprehensive analytical infrastructure complements this capability.
A. Contract Development
Drug Substance Services
- Chemical process development (Pre-clinical to P-III/Commercial
- Drug substance manufacture, including HPAPIs
- CMC and regulatory filings support
- Custom synthesis
Analytical Development Services
- Method development
- Method validation
- Stability studies
- Impurity identification, characterization
- Reference standard characterization
Product Development Services
- Pre-formulation studies
- Dosage form development for NCEs
- Formulation development and filing support for NDA submissions
B. Contract Manufacturing
APIs, Finished Dosage Forms & Starting Material
- Tech-transfer from client sites with project management support
- Securing RM supply chain by continuing existing sources and identifying new cost-effective sources; back-integrating the manufacture wherever necessary
- Custom build and dedicate equipment trains, blocks and manufacturing facilities, wherever necessary
C. Niche Solutions
- Extensive experience in handling manufacture of Highly-Potent (Cytotoxic and Steroidal Hormones) APIs & Intermediates both at Pilot scale & commercial scale ; Dedicated cGMP Containment manufacture capability at all scales and across multiple sites.
- Facilities designed for enabling operational containment levels of OEL <1μg/m3
- Conventional column chromatography capability laboratory, pilot and commercial scale; Adequate preparatory HPLC expertise & capacities: Lab-scale (100ml /min) to pilot scale (1000ml/ min) (Agilent & Knauer) & Column packers (Novasep & Asahi Kasei) ; Pilot scale to commercial scale SMB installations - Novasep varicol 6X50mm @ pilot-scale & 5X300mm @ commercial-scale
Collaborative and Integrated Offerings
- Integrated Drug Substance and Drug Product Development
- Dedicated facility deployment and manufacture