Industry: Biosimilars & Pharmaceutical Manufacturing
Buyer Persona: Quality Assurance Managers, Manufacturing Process Engineers, and Operations Directors
Author: Madhava Krishna
Publish Date: 17 October, 2024

Reducing Biosimilar Batch Failures to Improve Throughput by 5.73%

Introduction

The Pharmaceutical Biosimilar Company faced significant challenges in controlling batch failures, which led to reduced throughput and financial losses.

After implementing Lean Six Sigma methodologies, the company experienced a 5.73% reduction in batch failure rates and a financial benefit of ₹7.58 crores annually.

This case study outlines the collaboration, tools, and results achieved by optimizing their biosimilar production process.

The Story of Pharmaceutical Biosimilar Company

The Pharmaceutical Biosimilar Company is a leading player in the biosimilar market, manufacturing drugs that replicate biologic medical products. Prior to engaging with Skilglobal, the company was experiencing a high batch failure rate of 8.1%, resulting in wasted resources and lower manufacturing efficiency.

As a result, the company was struggling to meet production targets and faced increased costs. To combat these challenges, the company decided to collaborate with Skilglobal to implement Lean Six Sigma solutions aimed at reducing batch failures, enhancing detection, and preventing failures before they occurred.

Success Metric #1: Batch Failure Reduction

Before implementing SKIL Global’s Lean Six Sigma methodology, the failure rate of biosimilar batches was 8.1% (7 out of 74 batches). Skilglobal introduced a DMAIC (Define, Measure, Analyze, Improve, Control) approach to tackle the underlying issues.

Key steps included:

• Conducting a detailed Lean Value Stream Map analysis to identify bottlenecks.
• Implementing Failure Mode Effect Analysis (FMEA) to determine failure points across 341 process steps.

By enhancing controls and focusing on error-proofing (Poka Yoke), batch failures were reduced to 5.73% (7 out of 122 batches). This improvement boosted throughput significantly.

The Client Speaks:

“SKIL Global’s structured approach helped us reduce our batch failures and improve overall productivity. Their team helped us identify the key issues and apply actionable insights to improve our process efficiency.”

Success Metric #2: Financial Impact

The reduction in batch failures had a direct and positive impact on the company’s bottom line. With failures reduced by 2.37%, the company achieved annual financial savings of ₹7.58 crores. This result was made possible through targeted improvements in the detection and control of failure modes using Lean and Six Sigma tools.

Additionally, process improvements were made to reduce inventory costs and optimize overall manufacturing operations.

Success Metric #3: Training and Capability Building

To sustain the improvements, the team at the Pharmaceutical Biosimilar Company was trained on Lean Six Sigma techniques, with several members earning Green Belt certifications.

SKIL Global also provided specialized training on why-why analysis for root cause determination, which empowered shop floor operators to proactively prevent future failures.

Learning & Development Impact:

• Lean Six Sigma Green Belt certifications for key team members.
• Enhanced team capabilities in failure mode detection and resolution.

Figure 1: Tool Application Table

Overall Results

By implementing Lean Six Sigma methodologies, the Pharmaceutical Biosimilar Company successfully reduced batch failures, optimized throughput, and achieved significant financial gains. These efforts not only led to immediate operational improvements but also established a framework for continuous improvement in their biosimilar production lines.

The company continues to benefit from its improved processes, better-trained staff, and cost savings, all of which position it for future growth.