Case Study: Flexible to customer requirements
Customer need
- Clinical supplies for 3 strengths of SR and 1 strength of IR tablets
- Change in project scope: SR formulation to floating tablet (having absorption in upper part of gut)
- Reduction in timeline by 8 months for production of first batch of clinical batches
What we did?
- Additional API-excipient compatibility study accommodated after scope change
- Additional aspects of effervescent matrix for tablet flotation and density based use of polymers evaluated for formulation development for one strength
- Parallel development of all strengths for all release profiles after development of the first formulation
- Significantly reduced timelines for RM procurement, vendor approval and internal processes and documentation by assigning top priority and escalations
Value to the customer
- Successfully developed formulation with complex requirement for absorption
- Clinical trials could be advanced by 5 months due to early supply of clinical batches
Case Study: Offering cost effective solutions
Customer need
- Development and manufacturing of hormonal formulation
- Need to minimize development activities due to expensive API (~$ 100,000 / kg)
- Variation in dissolution performance and level of degradation impurity due to variation in API
What we did?
- Minimized API usage by using Design of Experiment concept to maximize data
- Characterized API and developed revised API particle size specification
- Identified degradation mechanism and implemented manufacturing controls
Value to the customer
- Cost saving in development by optimum use of API
- Efficient manufacturing process by redefinition of API specifications and addressing areas of concern
Case Study: Delivering tight timelines
Customer need
- Phase II tablet development and scale-up batches for US Big Pharma
- Moving targets for all milestones of project
What we did?
- Ensured complete understanding of customer requirements through quick communication upfront and internal training to bring the team up to speed
- Initiated licensing procedures in parallel
- Daily communication with customer to ensure daily alignment of expectations and optimal utilization of resources
Value to the customer
- Timely development of formulation with moving project timelines
- Process scale-up matching customer expectations