Biologics Pharma Innovation Programme Singapore (BioPIPS)

About the Grant Call

This grant call is from the Compliant Agility workstream which focuses on removing manual tasks to achieve greater productivity in the manufacturing facilities while maintaining compliance by using solutions, e.g. robotics, automation and advanced analytics.

• Problem Statement 1: Defect Detection of Single-Use Systems
• Problem Statement 2: Redesigned Manufacturing in Compliant Agility

Problem Statement 1: Defect Detection of Single-Use Systems

This grant call seeks proposals to develop solutions which can –

1. Automate the detection of defects within SU assemblies and bags, in particular for those listed below (see Annex A for details) but not limited to –
   a. Incomplete or mis-assembly, such as missing or incorrect components, improper component orientation
   b. Incomplete points of sealing, e.g. port seal and film seal
   c. Embedded particles (>100 μm present in SU assemblies or bags)
2. Improve repeatability and reduce operator variability associated with manual visual inspection through the use of, but not limited to, imaging, computer vision, machine learning, optical sensing, spectroscopic methods or other relevant detection modalities
3. Support regulatory compliance by generating objective, reproducible inspection records suitable for GMP or regulated bioprocessing environment

Problem Statement 2: Redesigned Manufacturing in Compliant Agility

This grant call seeks proposals for solutions to –

1. Automate High-Risk Manual Operations: Develop solutions to reduce contamination risk and manual intervention in critical activities, such as –
   • Media preparation
   • Sampling
   • Equipment configuration, setup and breakdown
   • Materials and wastes handling
   Proposals can include retrofit solutions for existing isolators and legacy processes as well as greenfield concepts


2. Minimise Contamination Across Sterile Boundaries: Design systems to safely manage robotic and materials movement between sterile and non-sterile zones through –
   • Improved barrier technologies
   • Segmented workflows
   • Controlled transfer pathways
   • Advanced environmental containment strategies
   Solutions must maintain or improve current sterility assurance levels


3. Redesign Equipment For Robotics Operations: Redesign single-use and multi-use equipment for robotic manipulation and automated configuration by emphasising –
   • Sterilisable and low-particle materials
   • Modular and reconfigurable architecture
   • Robot-compatible interfaces
   • Simplified setup, operations and cleaning
   Proposals can explore shifts from high-volume/low-frequency batch production, e.g. ≥1000 L towards low-volume/highfrequency or hybrid batch-continuous manufacturing models


4. Future-Ready Facility And Workflow Architecture: Propose facility concepts optimised for automation and ‘lights-out’ manufacturing, including –
   • Robotics-enabled spatial configurations
   • Separation of human and robotic workflows
   • Alternative sterilisation zoning strategies
   • Closed or near-closed production environments
   Concepts can address both greenfield facilities and transformation pathways for existing plants


5. Define The Robotics Lifecycle In GMP Environments: Establish frameworks to manage robotic systems within regulated manufacturing environments, including –
   • Sterility and particle control
   • Maintenance and service models
   • Power and charging strategies
   • Human–robot interaction protocols
   • Compliance validation and monitoring
   Solutions must align with GMP requirements and regulatory expectations

Different types of collaboration are encouraged. Some ideas can be standalone research projects while others require pulling together different collaborators to take forward. Some of the ideas above are likely to need phasing or drawing from concepts already deployed in other industries, e.g. semiconductor, automotive or nuclear.

Eligibility

The Principal Investigator and Co-Investigators as defined in Grant Terms and Conditions must:

1. Hold a primary appointment in a Singapore publicly funded research institution or an Institute of Higher Learning. The Principal Investigator must hold a primary appointment of at least 0.7 FTE in Singapore.
2. Lead a laboratory or research programme which carries out research in Singapore
3. Possess track record of leadership ability in coordinating research programmes and providing mentorship to research teams as well as having productive research outcomes. A track record in securing IRS will be advantageous.

Collaborators as defined in Grant Terms and Conditions are not eligible to receive funding. Companies can participate in projects only as collaborators.

Exceptions to the above eligibility criteria will be considered on a case-by-case basis. Please submit a request to the BioPIPS Programme Office at least 7 days before the closing date of the grant call.

31 Biopolis Way
#08-01 Nanos
Singapore 138669