5 process improvements for plasma fractionation and purification

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Niranjan Kulkarni, PhD

Sr. Director Consulting Services

Here are five mini-case studies that improved the production process for plasma-derived proteins because every drop of plasma counts.

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A single hemophilia patient relies on 1,200 plasma donations each year. Blood plasma protein therapies go beyond this treatment, continuously helping patients with immunodeficiencies, cardiopulmonary, and other life-threatening conditions. It can also take up to 12 months to manufacture some plasma-derived medicines, adding to the sensitive nature of this critical supply chain.

Efficiency in the plasma fractionation and purification process is essential. With decades of experience designing, building, and consulting on plasma facilities, CRB’s SMEs have identified practical ways to optimize the plasma fractionation and purification process. We hope sharing some of these findings in the examples below helps the industry enhance operations and better serve the patients in need.

Five process improvement examples for plasma fractionation and purification

CIP skid utilization

Plasma process challenge: High utilization and process restrictions limited CIP skid availability.
Operations study: We created a process model to analyze the manufacturing unit operations to identify potential causes of conflicts when more than one unit operation requests the CIP skid at the same time.
Process improvement: We reassigned CIPs to resolve existing conflicts and minimize the impact of future process interruptions.
Project outcome: Increased throughput by over 10%.

Fewer filter presses

Plasma process challenge: Filter presses were underutilized as each filter press was dedicated to a single plasma protein fraction and separation durations are relatively short compared to protein precipitation durations. The filter press utilization also had to account for complicated manual setup and cleaning sequences, which can be highly variable in duration. Adding to the challenge, this client also wanted to implement fully automated process transfers to and from the filter presses, which made filter press assignment flexibility difficult.
Operations study: Through modeling & simulations, CRB quantified filter press utilizations to reveal the degree of underutilization. An improvement pathway was identified to allow certain plasma protein fractions to share equipment without violating operating and design constraints.
Process improvement: We reduced the number of filter presses needed.
Project outcome: Maintainability was improved with fewer filters to focus on. Operator utilization also improved, eliminating the need for a planned increase to headcount.

Managing traffic flows

Plasma process challenge: Throughput increases were planned for corridors and airlocks already experiencing high traffic and congestion.
Operations study: We conducted detailed material, equipment, and personnel flow analyses to assess current and future bottlenecks. We used quantitative and visual outputs, such as heat maps, to help the client understand future congestion.
Process improvement: CRB proposed spatial and temporal segregation of activities to manage this traffic.
Project outcome: We managed and alleviated notable traffic spikes with problematic congestion during certain times of the day.

Help from warehouse automation

Plasma process challenge: Warehouse staffing could not accommodate the planned multi-year run rate increase.
Operations study: We investigated automation options to offset the need to increase warehouse staff.
Process improvement: We developed a tool to determine resource-sharing opportunities.
Project outcome: We enabled the client to maintain the existing staff while justifying automation in certain instances where the net present value of automation solutions was financially favorable.

Mapping material movements

Plasma process challenge: The manufacturer needed to reduce out-of-spec conditions and optimize material and personnel travel time.
Operations study: Material and personnel flow mapping and layout analysis were developed by shadowing the client’s operations from material receipt and freezer put-away through manufacturing point-of-use.
Process improvement: New travel paths were established to ensure quality is not compromised and travel times are optimized.
Project outcome: We reduced operator’s travel distance, time and number of handlings. The study also identified the optimal location for a new -30C freezer.

Improving your process

Lean methodologies, such as Gemba walks, provide opportunities to identify workflow inefficiencies and operational bottlenecks. When managers and employees regularly engage in onsite Gemba walks, it promotes a culture of continuous improvement as greater efficiency is always being teased out.

Similarly, you can use lean tools like value stream maps, spaghetti maps, block diagrams and digital twin simulations to identify, prioritize and quantify low-hanging fruit for improvement. However, process improvements need to be assessed holistically to prevent simply shifting the inefficiency elsewhere. For example, if you significantly increase throughput in manufacturing, will your QC lab be able to keep up? And what about your raw materials—will you need to keep more onsite or potentially increase shipments? This is a great place for a second set of eyes from an outside expert.

Over time, inefficiencies become business as usual. They are not always easy to spot for those closest to the operations, which is why a 3^rd party process improvement consultant can play such a pivotal role in identifying these opportunities for improvement.

Reach out if you’d like one of our process improvement consultants to walk your plasma fractionation or purification site to spot what you might be missing.