Success Stories in Drug Development Labs

 

Creating the optimum polymorph/crystal type for optimum solubility/stability

Increasing productivity with ELN in Pharmaceutical R&D

Improving Weighing Process and Time to Market


 
 

  1. Creating the optimum polymorph/crystal type for optimum solubility/stability

 

Problem The testing process for finding the optimum polymorph was painfully slow, extremely costly and often missed the optimum crystal type.
Solution Coalesce partnered pharmaceutical companies with a technology provider that had developed a new massively parallel testing platform that enabled Pharma/Biotech organizations to cut the time necessary to find the optimum polymorph and salt composition from months to 1-2 weeks, and cutting the material required to generate hundreds of crystallization experiments and thousands of data points down to as little as 0.5-2.0 grams of API.
Result $50 Million Dollars (USD) in Materials Savings, untold benefits in reaching market faster.

 

  1. Increasing productivity with ELN in Pharmaceutical R&D

 

Problem Lack of efficient collaboration and record keeping was reported as a major challenged by pharmaceutical research groups that had been using traditional paper notebooks or hybrid notebooks (scanned pages).
Solution Coalesce partnered pharmaceutical companies with a developer of an innovative Enterprise Electronic Laboratory Notebook to increase the efficient in Discovery, Pre-Formulation, Formulation, and Process Development departments. ELN software was implemented in Medicinal Chemistry and Process Development departments. Company was able to quickly create almost 20,000 after implementation of the ELN software.
Result 66% of scientists saw efficiency gains and felt ELN increased their individual productivity. Improvement of quality and quantity of records in the short-term by being able to clone experiments, and to organize and store process related information from multiple experiments in the context of the recipe, was reported.

 

  1. Improving Weighing Process and Time to Market

 

Problem Working with sensitive and expensive substances in the pharmaceutical industry has been the reason for safety and costs challenges as well as compliance issues with FDA and GMP requirements. Loss of milligrams of substance meant lost of thousands of dollars.
Solution Coalesce partnered pharmaceutical companies with a developer of a novel Automated Weighing and Dosing System to increase the efficiency in Testing, Quality, Formulation, and Manufacturing departments. After installation of the automated weighing system, companies could manage dispensing and dosing operations at the workstation and with the highest precision.
Result Double the speed of their weighing processes. Increase experimental series 50% and add quality gains. Overall, time to market was reduced to half the time.

 

  1. Reducing finished product inventories and inconclusive microbial ID results.

 

Problem Bacterial and fungal contamination poses serious challenges to pharmaceutical companies, especially to those that don’t have the means to indentify microbes quickly and effectively. Carrying finished product inventories for a long time due to slow testing significantly increases costs and reduce margins.
Solution Coalesce partnered pharmaceutical companies with a developer of newly validated Microbial Identification System aimed at helping reduce test time and minimize risks associated with production downtime. Pharmaceutical companies doing phenotypic testing usually experienced inconsistent or inconclusive results and slow identification time. Those relying on outsourced services experienced either long turnaround time or expensive expedite service fees. After installation of a newly validated Genotyping Microbial Identification system, companies were able to obtain faster, more accurate and more reproducible results than traditional phenotypic methods.
Result Three-year return on investment of ~160% and break-even after 11 months (validation period 4 of months and payback period after validation of 7 months). Reduced cost in finished product inventory. Decreased number of IDs sent out to a contract lab, many of which required expedite processing and fees.