PRODUCT LIFECYCLE MANAGEMENT
Product Lifecycle Management
DRUG LIFECYCLE
AND QUALITY
BY DESIGN
While they bring great hope to patients, new therapeutic approaches are not without their challenges, which have a strong impact on the economic environment of the pharmaceutical industry. They require a perfect understanding and control of the drug Life Cycle and its different phases.
THE CHALLENGES OF
NEW THERAPEUTIC APPROACHES
New therapeutic approaches have emerged in recent years.
They have led to the rapid development of new treatments such as gene therapy products or messenger RNA vaccines.
Increasingly effective and better targeted, they allow patients to receive better treatment with fewer side effects. They represent important hopes for all patients waiting for treatment, often for serious diseases.
At the same time, the objective to control healthcare costs, and in particular the pressure on prices, promote generic drugs and biosimilars. These two aspects combine to profoundly change the economic environment of the pharmaceutical industry. This involves a reduction of the drugs marketing authorization under patent by the laboratories that discovered them by investing enormous human and financial resources.
The Life Cycle of a drug, from development to the loss of patent protection, is thus constrained by the need to accelerate the time to market and to guarantee a first in class industrial performance.
QUALITY BY DESIGN TO GUARANTEE
A TOP QUALITY PRODUCT AND
PROCESS PERFORMANCE
It is essential to ensure absolute quality throughout the production chain and successful industrialisation.
A Quality by Design approach at the beginning of the process optimises the industrialisation and meets the regulatory requirements.
Everything must be done to design a manufacturing process and a control strategy which allow, on a permanent basis, the manufacture of a quality product while maintaining a strong industrial performance. For this, the design of the process to be industrialized is crucial and requires a "Quality by Design" approach.
It is based on scientific knowledge of the product, with high performance manufacturing technologies and on a risk analysis and control approach.
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A successful industrialization relies on a good process design upfront, thanks to a Quality by Design approach
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Scale-up and technology transfer are optimized to industrialize efficiently, to achieve process performance qualification and to control the commercial process over the long term through continuous process verification. These elements are expected by American and European regulations.
MASTERING THE DRUG LIFE CYCLE WITH STRONG COLLABORATION DRIVE THE SUCCESSFUL MARKET LAUNCH
The stakeholders involved in bringing therapeutic innovations to market quickly are numerous and the interactions are increasingly complex. This is partly explained by the new advanced technologies implemented, which often lead to new questions and new technical issues to be solved.
For breakthrough innovations, particularly when it comes to treating rare diseases or patients awaiting last hope treatments, close collaboration between innovative companies, research, industry and regulatory authorities is necessary in the interest of patients. All possible innovations are then considered in the execution of the three phases of the drug life cycle, while maintaining quality and safety.
Establishing close collaborations between different stakeholders, a benefit for patients waiting for last hope treatments
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CURRENT CONTEXT
In 2021, the Food and Drug Administration (FDA) approved 55 new drugs, many of them from biotechnology. Innovative treatments from start-ups or mid-sized companies are booming.
These companies are first class positioned scientific expertise and innovation. However, they often miss the perspective and experience to rapidly industrialize their discoveries to make them accessible to patients, and they are not enough familiar with the regulatory requirements and industrial constraints. These two difficulties, industrial and regulatory, highlight the crucial importance of understanding and controlling the three phases of the drug life cycle: quality-by-design, industrialization and process control.
