Case Studies

These case studies provide an in-depth look into the challenges some life sciences companies have faced and the methodologies and solutions implemented by Tunnell to solve the problem and provide sustainable results.

Analytical Methods Certification: Certifying Analytical Methods to Meet Regulatory Expectations

All 259 reports were found to be compliant with only one minor observation.

 

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Getting Up to Speed and Staying There: Lean Lab Improvement That Lasts

Tunnell acted as a sounding board, ultimately leaving the client with a sustainable Lean operation.

 

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Beyond Operational Excellence: Creating a Culture of Cost Improvement

The company realized improvement on the scale and at the speed it needed.

 

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Planning for Profits: Getting Organizational Design Right in Biologicals

A new design profitably reshaped the organization and ensured the right behaviors.

 

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Compliance Under Pressure: Rapidly Reducing Deviations and Increasing Right-First-Time – and Sustaining the Improvements

The plant was brought into compliance and continues to generate exceptional results.

 

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Rapid Process Understanding: Getting to the Root Causes of Revenue-Threatening Product Problems

The team developed a set of formulation-related, process-related and packing-related optimal operating parameters.

 

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Process Capability and Control: Getting to the Root Causes of Variation – and Saving a Product Line

The company replenished supply to the market and realized a savings of an estimated $2 million annually.

 

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Fast tracking Facilities Start Up: Rapidly Turning Investment into Revenue

The company met — and exceeded — its ambitious goals.

 

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Quality Culture: Charting the Path to an Organization-Wide Commitment to Quality, Compliance and Right-First-Time Performance

The client now has a comprehensive roadmap for creating a sustainable Quality Culture.

 

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Assessing Risk in Seeds & Cell Banks Practices: Avoid Costly Disruptions in Vaccine Manufacturing

Tunnell assessed each risk identified and evaluated its degree of potential impact.

 

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