Laurus Labs

Laurus Synthesis

The core-strength of Laurus is its innovative, robust & scalable chemistry - making use of which, multiple developmental candidates of client organizations have been handled at all stages of drug lifecycle right from route identification through to custom synthesis and from early clinical through to commercialization. Even while handling semi-mature processes of late-phase clinical candidates OR while conducting tech-transfer of mature processes of marketed APIs &/ or KSMs for eventual contract manufacture, our development & manufacturing teams have a tight focus on aspects such as performance at scale, continuous process improvement, securing and de-risking supply chain et al thus providing an efficient, compliant, cost-effective and long-term commercial drug substance solution.

The strong analytical chemistry team at Laurus works closely with the chemical development & tech-transfer teams as the process evolves & provides all necessary and phase-appropriate support to the client organizations involved on their drug substance as well as drug product analytical development needs. The drug product development team at Laurus is fully capable & equipped to develop all type of formulations both for NCEs & Generics and other specialty products. This capability is ably complemented by the comprehensive analytical infrastructure in place.

While the Indian operations service the global clients, taking into cognizance a need for intensive iteration with their CRO partners of a section of drug discovery, pharmoutsourcers in USA, Laurus established a fully owned subsidiary Laurus Synthesis Inc. in the drug-discovery hotbed of Boston, MA. The high caliber team here can support clients on their early to late-stage chemical development needs and work in tandem with the India site for providing a complete scale-up solution to the North American client organizations bringing to them, literally the best of both worlds.

Utilizing the core competencies of the specialized work-force and the manufacturing expertise within the larger organization, Laurus synthesis division offers services in two distinct segments of Contract Manufacture & Contract Development.

With strengths in flexi-scale drug substance manufacturing & phase appropriate chemical & analytical development capabilities, Laurus labs is well positioned to meet all NCE drug substance needs of the client, preclinical through to commercial manufacture.

CONTRACT DEVELOPMENT

Drug Substance Services
Chemical process development
Drug substance manufacture, including HPAPIs
CMC & regulatory 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 for ANDA submissions

CONTRACT MANUFACTURE

APIs & Starting Material
Tech-transfer from client sites aided by effective project management
Secure RM supply chain by continuing the existing sources & identifying new cost-effective sources &/or back-integrating the manufacture where possible
Custom build and dedicate equipment trains/ blocks/ manufacturing facilities as required

Niche Solutions
Large-scale chiral separations utilizing the pilot & commercial-scale SMB capabilities
Collaborative models including IP-share, revenueshare models of development, facility deployment and manufacture
Top