Inbiopro’s process development capabilities are defined by a bold yet practical paradigm:

• Address cost pressures by engineering novel, alternative approaches and technologies;
• Use them as viable, productive, and cost-effective substitutes to replace existing templates in manufacturing processes;
• Integrate ‘Quality by Design’ into all aspects of process and product development, combined with a thorough knowledge of current Good Manufacturing Practice (cGMP), its principles and implications on research.

These capabilities are governed by strict product and process parameters, which affect quality and commercials.

• Process parameters: scalability, robustness, consistency, and repeatability;
• Product parameters: purity and yield, and similarity.

Process parameters

Inbiopro’s engineering teams architect productive, viable processes, which: 

• Are scalable. An easy-to-scale process, with extensive screening for the right technology for every unit operation, can counter the cost pressures that hamper bioprocess manufacturing. Our engineers work with this understanding to thoroughly evaluate scalability properties before embarking on preliminary feasibility studies.
  
  We know that large-scale trials are often done with little time for process iterations. Therefore, scaled down models play a crucial role in defining process development and identifying changes to be incorporated while designing the large-scale process.
  
  While downstream processes still pose to be the cost limiting factors, selection of an economically competitive process starts with a robust and stable high expression system. While we are investing in this platform and have partnered with some novel high expression platform technology providers across the world, we are currently open to adopting and exploring  different high expression platforms especially for the mammalian systems.

• Are robust. A robust process ensures that the characterization and validation test data from the scaled down model is easily accepted and adopted in the large-scale manufacture. So, we follow a self-adopted mandate to design worst-case scenarios during contamination clearance and spiking studies, while defining process development.

• Are consistent. Inbiopro firmly acknowledges that consistent processes result in consistent product quality. Extensive Failure Mode and Effect Analysis (FMEA) generation is built in to our process development methods, which selects critical parameters and examines the edge for failure. We also pay keen attention to consistency parameters during process transfer, comparing our in-house process with the established ones at the final manufacturing site for changes, however minimal or trivial. This leads to educated additional characterization studies at a scaled-down model in the new site.

• Validate cost of cleaning. Large-scale biological manufacturers need to validate the cost of cleaning against the effectiveness of using disposable platforms and devices. While building adaptable processes, we plug in these choices into the scaled-down models. We are constantly evaluating new developments in disposable devices – from fermentors and filters to pre-packed chromatography columns – at scaled down models for their feasibility and success at large scale.

Product parameters

Inbiopro knows that making safe, high-efficacy biologicals implies zero room for inconsistency in product purity. Our product development initiatives are built to exacting standards of purity, and deliver maximum yield cost-effectively.  To achieve this, we collaborate with key device manufacturers, as they facilitate technology innovation and support process optimization. From selecting the fermentation media to charged depth filters to material of construction of chromatography base matrix, we are involved in scouting, assessing, and selecting the right components, and defining their application in the process.