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Workstreams

The workstreams within PIPS 2 include Active Ingredients to Product Interface, Agile Factory of the Future, Manufacturing Technology Platforms, Plant Operations, and Tools for Accelerated Process Development and Process Technology. There are 2 sub-workstreams namely, Nitrosamines and Sustainable Waste Management in the Active Ingredient to Product Interface and Agile Factory of the Future, respectively. The horizontal themes namely Sustainability, Digitalisation and Automation and Experimental Design and Modelling are integrated throughout the entire PIPS programme.


Active Ingredient to Product Interface

This workstream aims to make the whole supply chain more agile and responsive by linking the active ingredient process directly to formulation. Direct compression is a target for all pharmaceutical companies as it removes several complex processing steps. We aim to enable any active ingredient of choice to go directly into compression. The total VA depends on the number of new products coming through the pipeline and the need for reformulation of current products. For Syngenta, solid tablet forms are currently not generally practical due to the challenge of long-term stability and need for rapid dispersion in application. If it were possible to make solid formulations with these properties, it could revolutionise the business. We also aim to enable any active ingredient to go into stable suspensions which will open up new product opportunities, e.g. long acting injectables.

Agile Factory of the Future

All major pharmaceutical companies are reviewing their manufacturing operations and requirements for future factories. Pfizer is developing a new site in Singapore, while MSD is developing a new site master plan (with an Extended Team member – Bryden Wood), and GSK has introduced its continuous pilot plant in Singapore. This workstream aims to establish new approaches to agile factory design and operations – technology transfer, changeover between manufacturing processes and flexibility. The target is to expand operations in Singapore with the local sites being the site of choice for new product deployment within each company.

Manufacturing Technology Platforms

In the longer term, new technologies which produce less waste are required to reduce emissions and costs of materials and waste disposal. This workstream aims to develop new and more efficient manufacturing technologies which can be implemented in existing sites to take advantage of future smaller volumes and greater number of products.

Plant Operations

Plant Operations

This workstream focuses on discovering and implementing solutions to improve visual inspection, cleaning protocols, sensors, and membrane technologies to enhance plant operations and handle high potency materials.

Tools for Accelerated Process Development and Process Technology

Vision

A dynamic and agile approach to enable rapid launch and commercialisation of multi-product portfolios, enabling the robust, sustainable supply of zero-defect products while reducing process development lead time and at-risk investment, while maintaining or improving outcome quality and delivering the greenest possible process at filing.

Target

Reduce the time to design and gain regulatory approval of the manufacturing processes required to make medicines.
This will be affected by route selection, speed, manufacturing processes and the fulfilment of clinical and file requirements. Parameters include knowledge, resources, manufacturing velocity, chemical and process design speed, deployable equipment, modelling/simulation, and workflow/systems to capture data through experiments.

Tools Process Flow 2023

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Sub-Workstreams

Prediction and control of nitrosamine formation in Pharmaceuticals

This sub-workstream focused on the 4 problem statements that were developed with Nitrosamines at their core.

  • Modelling Impact of Amine
  • Identification and quantification of key factors driving NNO formation in OSD coupled with development of predictive model
  • API Coating / Surface co-crystallisation
  • Design of degradation studies to predict potential for vulnerable amine and/or N-nitrosamine formation

Sustainable Waste Management in the Agile Factory of the Future

Vision

Sustainable waste, water and solvent management in agile factories. 

Focus Areas

Embed sustainability in modular/continuous manufacturing processes:
  • Achieve water circularity inside the factory
  • Identify solutions aligned with the carbon neutral targets
  • Identify holistic methods to evaluate and select solvents to allow >99.9% recovery and reuse of solvents
  • Methods to render aqueous stream fully biodegradable (99.99% removal of BOD/COD, RQ<1)
Risk Quotient = RQ = PEC/PNEC
PEC = Predicted Environmental Concentration
PNEC = Predicted No Effect Concentration