Basic Manufacturing KPI Development in Bioprocess Manufacturing: Schedule Attainment, Efficiency, and Quality

Bioprocess manufacturing is still manufacturing, and better faster cheaper will always be lurking in the background. Make sure you’re building this culture with your team, because it matters now more than ever.

The year 2023 brings new challenges and opportunities to bioprocess manufacturing. The climate for biopharmaceutical production has evolved, emphasizing the need for better Phase I data, management of shorter runways, and finding some way, dear God, of maintaining investor confidence. One crucial aspect to address these challenges is the development and monitoring of Key Performance Indicators (KPIs) for manufacturing or even regular process development activities. A decent dashboard goes a long way — it’s your job to keep your team focused on the bal, and if you can define the KPIs, you define the ball. In this article, we will delve into the fundamental KPIs associated with bioprocess manufacturing, specifically schedule attainment, efficiency, and quality, and explore how they align with the 2023 climate of the industry.

Schedule Attainment

Meeting the Timelines in an ever Shifting Landscape

First and foremost — this needs to be your #1 KPI — NUMBER ONE. You cna get more money. You can rebuild a construct that was built poorly. You cannot get time back. In 2023, the bioprocess manufacturing industry faces increased pressure to streamline production timelines. The development of better Phase I data is contingent upon efficient manufacturing practices. To ensure schedule attainment, it is crucial to establish KPIs related to production timelines.

• KPI 1: Production Schedule Adherence: Monitor how closely the manufacturing process adheres to its planned timeline. Regular assessment ensures that production is on track, which is particularly important for shorter runways and maintaining investor confidence.
• KPI 2: Changeover Time Reduction: Decreasing the time required for batch changeovers and equipment set-up can expedite the production process. Shorter changeover times contribute to faster Phase I data generation and decreased investor concerns about project delays.

Efficiency

Optimizing Resource Utilization for Sustainability

Efficiency is a key focus for bioprocess manufacturing in 2023. Sustainability and resource optimization have become top priorities. Lean manufacturing principles play a significant role in achieving these objectives.

• KPI 3: Resource Efficiency: Measure the utilization of resources such as raw materials, energy, and equipment. A more efficient use of resources aligns with the industry’s push for sustainability and can positively impact production costs, critical in the climate of heightened scrutiny on expenses.
• KPI 4: Lean Manufacturing Implementation: Assess the implementation of Lean principles, which aim to eliminate waste and streamline operations. Lean techniques, such as Just-In-Time (JIT) production, can contribute to shorter runways and reduced waste, ensuring cost-effectiveness and faster Phase I data generation.

Quality

Consistency and Regulatory Compliance

Quality is non-negotiable in bioprocess manufacturing, and it’s paramount in the 2023 climate where investor confidence hinges on product reliability and consistent Phase I data.

• KPI 5: Product Quality Metrics: Track product quality parameters such as purity, consistency, and potency. Quality by Design (QbD) principles should be incorporated to design quality into the process, reducing defects and deviations and ensuring consistent product quality.
• KPI 6: Regulatory Compliance Index: Regularly assess the level of compliance with Good Manufacturing Practices (GMP) and other regulatory requirements. Ensuring compliance not only maintains product quality but also builds investor confidence in the integrity of the manufacturing process.

Bring it all Together

Many of these KPIs won’t be relevant to you — find some that are, and stick to the principles of time, money and progress. Once you have your KPIs together, you need to look at them. At least weekly, daily once you can get there — this is minimal input for large payoff once you have a system together, and nothing breaksdown siloes better than transparent data. Build with the company goals in mind, not the department or any individual feifdom, and you can keep the