Portfolio & Case Highlights

Examples of how Biovigyaana has helped biopharma organisations and academic institutions achieve their goals through expert consulting and training.

Our Work

Selected Engagements

Each engagement is unique. Below are representative examples illustrating how we approach consulting, training, and excellence challenges across the biopharma sector.

Case Studies

Process Optimisation for a Biopharmaceutical CMO
Consulting

Process Optimisation for a Biopharmaceutical CMO

Client type: Biopharmaceutical Contract Manufacturer Duration: 6 months

The Challenge

A contract biopharmaceutical manufacturer faced yield inconsistencies in their mAb production process, leading to batch failures and increased manufacturing costs.

Our Approach

Comprehensive process audit, root cause analysis, design-of-experiment based optimisation of critical process parameters, and enhanced monitoring protocols.

Key Outcomes

  • Significant improvement in average batch yield
  • Material reduction in batch failure rate
  • Improved process understanding and in-process control
  • Enhanced documentation and operator competency
Process DevelopmentQuality SystemsCMOmAb Production
Training

Bioprocess Training Programme for a University Department

Client type: Pharmaceutical Science Department, Leading Indian University Duration: 3 months

The Challenge

A university department sought to upgrade their students' practical knowledge of industrial bioprocessing to better prepare graduates for careers in biopharma.

Our Approach

Curriculum gap analysis, design of a modular training programme covering upstream/downstream processing, quality systems, and regulatory fundamentals—delivered by industry experts.

Key Outcomes

  • Comprehensive 40-hour modular training programme developed
  • Practical case studies integrated into the curriculum
  • Student feedback scores above 4.5 / 5.0
  • Established ongoing industry–academia advisory relationship
Training DesignUniversity PartnershipBioprocessCurriculum Development
Bioprocess Training Programme for a University Department
GMP Readiness Assessment for a Biosimilar Developer
Excellence

GMP Readiness Assessment for a Biosimilar Developer

Client type: Emerging Biosimilar Development Company Duration: 4 months

The Challenge

An emerging biosimilar developer preparing for their first regulatory submission needed a comprehensive assessment of their quality systems and GMP readiness.

Our Approach

Structured GMP gap assessment against ICH Q10 and WHO guidelines, risk-based prioritisation of findings, development of a remediation roadmap, and support for quality system implementation.

Key Outcomes

  • Comprehensive gap assessment report delivered
  • Prioritised remediation plan with timelines and owners
  • Key SOPs and quality documents developed and approved
  • Team upskilled on GMP expectations for biologics
GMPQuality SystemsBiosimilarsRegulatory Readiness

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