Reflection – Learning Launch

Design Thinking - A new perspective in Analytical Research and Development in Generic Industry

Challenge

Being an analytical research scientist in Generics industry, agility is the new normal to survive in the  current cut throat competition. The motto is First to market to cater to unmet needs of patients in the  world.

Generics product development contains making a bio-equivalent product of the innovator product  which is already existing in the market. The pharmaceutical companies has to identify the marketing  opportunities and develop new generic products. The faster the development, better are the returns.

The critical chain for the development of generic products is the analysis time and solvent  consumption. The analysis methods should be robust and be able to identify the variations which may  occur in different batches of the same product. The solvent consumption leads to heavy cost to the  company. There is chance of reducing the solvent consumption through shorter run time methods.

Selection

We focus on implementing the following to develop robust products by applying agile concepts

1. Design Expert tool (Quality by Design tool) – This will help us in understand the robustness of  the analytical method. We can build the quality into the process leading to reproducible  methods at quality control.   2. Multi-Dose dissolution apparatus – This equipment helps us to screen 8 different batches  simultaneously   3. Fibre Optics in dissolutions – For online monitoring of dissolution results.  4. Smart knowledge transfer – Usage of google glass technology for effective knowledge transfer  between R&D facility and manufacturing locations.   5. Application of data management tools (Information mapping) – Mining of Vast data and  consolidating into information.  6. Applying new separation techniques (HPLC vs UPLC) to reduce overall run time of analysis.

Application

The target of above techniques are

1) Reduced solvent consumption by reducing run time for analysis.   2) Simultaneously screening multiple batches.  3) Quality by design as a tool for monitoring the robustness of the product.  4) Instead of re-inventing the wheel, leveraging the vast data and mining quality information.   5) The R&D process has been recorded real-time by using google glass and sharing the same to  quality control to prevent the manual intervention. The process at quality control while  knowledge transfer can be monitored real-time by sitting at R&D.   6) As a pilot project, two products were selected for improvement by applying new tools. The  products were run in fibre optics dissolution apparatus and the results are matched with

conventional process. The run time in HPLC has been reduced by following new equipment of  UPLC where the run times are shorter further saving the solvent consumption for the analysis.   7) Now these techniques has been rolled out in all products.

Insight

By application of knowledge tools and new technology tools, we are able to successfully develop the  generic products in very short time. This has saved time and cost for the product development. The  friction between quality control and R&D department has also reduced a lot.

Approach

By application of the learning launch strategy of Design Thinking, we can have a strategic advantage  of resource optimization. The quality can be built into products instead of firefighting at the shop floor.

These methods helped us in removing common cause variation (variation inbuilt in the process) which  is very difficult to tackle.  Due to this, it has become easy to identify special cause variation (Variation  due to external factor).


Reflection – Learning Launch Design Thinking - A new perspective in Analytical Research and Development in Generic Industry Challenge Being an analytical research scientist in Generics industry , agility is the new normal to survive in the current cut throat competition . The motto is First to market to cater to unmet needs of patients in the world . Generics product development contains making a bio - equivalent product of the innovator product which is already existing in the market . The pharmaceutical companies has to identify the marketing opportunities and develop new generic products . The faster the development , better are the returns . The critical chain for the development of generic products is the analysis time and solvent consumption . The analysis methods should be robust and be able to identify the variations which may occur in different batches of the same product . The solvent consumption leads to heavy cost to the company . There is chance of reducing the solvent consumption through shorter run time methods . Selection We focus on implementing the following to develop robust products by applying agile concepts 1 . Design Expert tool ( Quality by Design tool ) – This will help us in understand the robustness of the analytical method . We can build the quality into the process leading to reproducible methods at quality control . 2 . Multi - Dose dissolution apparatus – This equipment helps us to screen 8 different batches simultaneously 3 . Fibre Optics in dissolutions – For online monitoring of dissolution results . 4 . Smart knowledge transfer – Usage of google glass technology for effective knowledge transfer between R&D facility and manufacturing locations . 5 . Application of data management tools ( Information mapping ) – Mining of Vast data and consolidating into information . 6 . Applying new separation techniques ( HPLC vs UPLC ) to reduce overall run time of analysis . Application The target of above techniques are 1 ) Reduced solvent consumption by reducing run time for analysis . 2 ) Simultaneously screening multiple batches . 3 ) Quality by design as a tool for monitoring the robustness of the product . 4 ) Instead of re - inventing the wheel , leveraging the vast data and mining quality information . 5 ) The R&D process has been recorded real - time by using google glass and sharing the same to quality control to prevent the manual intervention . The process at quality control while knowledge transfer can be monitored real - time by sitting at R&D. 6 ) As a pilot project , two products were selected for improvement by applying new tools . The products were run in fibre optics dissolution apparatus and the results are matched with conventional process . The run time in HPLC has been reduced by following new equipment of UPLC where the run times are shorter further saving the solvent consumption for the analysis . 7 ) Now these techniques has been rolled out in all products . Insight By application of knowledge tools and new technology tools , we are able to successfully develop the generic products in very short time . This has saved time and cost for the product development . The friction between quality control and R&D department has also reduced a lot . Approach By application of the learning launch strategy of Design Thinking , we can have a strategic advantage of resource optimization . The quality can be built into products instead of firefighting at the shop floor . These methods helped us in removing common cause variation ( variation inbuilt in the process ) which is very difficult to tackle . Due to this , it has become easy to identify special cause variation ( Variation due to external factor ) .