Business Continuity in Pharma: How we guaranteed Market Supply of a Vital Coagulation Factor through a New Manufacturing Process

Business continuity in Pharma / XLPM method / QIQO Pharma / New manufacturing process / Coagulation factor / Keep drug on market pharma

Navigating the Pharma Landscape with XLPM

In the dynamic world of pharmaceuticals, ensuring the consistent supply of critical drugs is paramount.

Our client specializes in the production of injectable products derived from blood plasma, such as coagulation factors and immunoglobulins. These injectable products, available in both liquid and freeze-dried forms, are among the most critical drugs in the medical world. Clotting factors are necessary to cure hemophilia, for example.

Facing the Coagulation Factor Challenge Head-On

The manufacturing process of one of their essential drugs involved several purification steps, primarily through filtrations. A significant setback occurred when one of the suppliers decided to discontinue the production of a crucial nanofilter.

In response, the R&D team developed a new manufacturing process, opting to modify the chromatography gel. Not only was a new chromatography gel validated, but the sequencing of the process steps was also adapted.

The primary objective was to ensure the continued production of this drug before the existing filter stock expired. Given the importance of stability studies and timely submissions to authorities, adhering to the schedule was of utmost importance. Stability studies are tests where samples are placed under study conditions for a defined period to assess any deterioration, ensuring the maintenance of the physicochemical properties of the products.

Revolutionizing Pharma with the XLPM and QIQO Approach

To perform all the modification of the process in time, it’s is important to apply a project management methodology.

As a project manager, our consultant implemented the XLPM methodology, a project management approach familiar to the client.

This structured methodology is divided into distinct phases marked by milestones.

For this project, there were three key milestones:

• defining the project,
• validating the budget,
• and closing the project post-implementation in routine production.

We used Planisware software for the project. Planisware is used to do the Gantt, follow the resources and document the milestones.

A dedicated project team was created, comprising individuals from Quality, Automation, Validation, Qualification, Technical, Process Expertise, and Production Operations.

We also introduced QIQO, conducted mixing studies, and executed both technical and validation batches. QIQO method is the way to perform all the needed verification in pharmaceutical industry. It’s a very complete method with different steps.

• QIQO involved various qualification steps to verify process conformity.
• A technical batch served as a test run, allowing us to experiment with various parameters.
• The validation batch, intended for sale, had to meet all routine conditions and was therefore critical.

Adapting to a new process, especially one that’s implemented daily, requires significant resources and strategic planning, including allocating production slots for specific stages.

Effective communication was key to the project’s success, and our consultant’s expertise helped maintain team motivation, ensuring the project was completed on time and within budget.

“XLPM methodology and QIQO method are standard used in pharmaceutical site to harmonized all the practices and fits with regulatory requirements.” – Alispharm consultant.

Achieving Seamless Transition in New Manufacturing Process for Business Continuity in Pharma

Our strategic approach and meticulous planning bore fruit:

• The technical and validation batches were executed on schedule.
• We achieved compliant results, meeting the stringent standards set by the industry.
• Our team successfully submitted the necessary documentation to the relevant authorities.

Empowering Business Continuity in Pharma: A Call to Innovate and Collaborate

In the ever-evolving pharmaceutical landscape, adaptability and strategic foresight are crucial.

Our expertise in navigating such challenges ensures that essential drugs remain available to those in need.

Contact us today, if you are facing similar challenges or are interested in our services and solutions.

You can also read more about Business Continuity Planning to Prevent Drug Shortages.