It’s ValGenesis story time! Today, we’ll talk about how we helped a company in accelerating the time-to-market of a drug product using a Quality by Design (QbD) framework.
As usual, our characters are confidential, but we are sure that we’ll be able to give you all the key insights about it. Are you ready to go on an adventure? Let’s go!
A Company who Needed Some Help!
Let’s start by meeting our main character: a pharmaceutical company whose objective was to develop an oral solid dosage form with a generic active pharmaceutical ingredient and accelerating its time-to-market, assuring its efficacy, quality, and safety to the patients.
At first sight, we already know that having a Quality by Design (QbD) framework is fundamental to accelerate achieving these goals and thus streamlining the regulatory submission process.
According to the ICH Q8 (R2), Quality by Design (QbD) is a systematic approach that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management.
In other words, we can say that QbD is a framework that assures that a process will consistently enables product quality and patient safety based on an in-depth process understanding. But the question is, how can it be applied to a real situation?
That’s our role in this story: help this company to apply the QbD concepts into action!
How to Define a QbD Framework?
We’ve got the expertise when it comes to defining QbD frameworks!
First, we started by establishing a Quality Target Product Profile (QTTP). Then, based on the process mapping it was possible to categorize Critical Quality Attributes (CQA) by assessing the risks for the patient in terms of impact and uncertainty regarding biological activity, PK/PD, immunogenicity and safety:
- High impact, high uncertainty: CQA
- High impact, low uncertainty: CQA
- Low impact, high uncertainty: CQA
- Low impact, low uncertainty: non-CQA
Once the criticality assessment was completed, it was time to plan and execute the Design of Experiments (DoE) that led us to the definition of a Design Space (DS).
We can say that a Design Space is the multidimensional combination and interaction of input variables (e.g., material attributes) and process parameters that demonstrates assurance of quality. Or, in other words, it’s the relationship between the process inputs and the Critical Quality Attributes.
This was a crucial step. It allowed us to define in what ranges the process could operate without impacting product quality.
At the same time, all preventive and detective controls, sampling frequencies and in-process controls were defined. Finally, a control strategy has been established along with a the definition of a strategy to manage and streamline potential the regulatory process for post-approval changes.
Have we Accomplished our Mission?
The answer is yes, it was an absolute success!
With our intervention, the company was able to apply the QbD concepts to process development. Besides, it was able to create a knowledge base for the product and easily evaluate the impact of potential process changes. This, obviously, supported science and risk-based decision making.
Following a QbD methodology, the company could achieve its goal: develop a flexible yet robust manufacturing process. And, more than that, assure consistent quality, safety, and efficacy.
We can Help you Implementing a QbD Framework!
Our team gives you all the support to implement a Quality by Design framework in your processes, for both the development of new products and for legacy products.
Due to our full understanding on the QbD framework implementation and our proprietary technology, we can help you with design space definition, process monitoring and supervision and in many other relevant topics regarding process optimization.
Your company can be our next story, take a look at our Quality-by-Design solution and feel free to contact us!