The value of innovation in a sector where any change can affect the registration of a medicine
The pharmaceutical industry needa to innovate in a continuous way to optimize its processes, increase efficiency, reduce development times and respond to scientific and technological challenges of a increasingly demanding market. However, it has to do it in a high regulated environment, in which pacient security is a essential requirement.
At this industry, the client is, in las instance, the pacient. This reality means that any innovation has consequences that go far beyond mere technical feasibility. Un like other industrial sector, introducing a new technology it is not just demonstrating that it works; it also has to be guarantee that it´s implementation doesn´t commits quality, security and neither the efficiency of the medicine.
| Module | Main content |
|---|
| 1 | Administrative and legal information |
| 2 | Quality, security and effectiveness sum ups |
| 3 | Medicine quality |
| 4 | Non-clinical studies |
| 5 | Clinical studies |
This requirement it´s articulated through the Good Manufacturing Practices (GMP), the joint of rules that regulate the manufacturing of medicines to assure that they are produced in a cohesive way and with the quality levels required from the health authorities.
However, the scope of the GMP goes further that the main manufacture process. It also affect to areas and facilities, services such as water, air, vapour, manufacture and conditioning equipments, IT equipments, analytical methodes and, in general, to any element that can influence on product quality and safety.
All this information is part of the Quality module, known as CMC (Chemistry, Manufacturing and Controls), integrated on the dossier or registration file of the medicine. It documents how the product is manufactured, with what equipment, under which conditions and throughout which quality controls. The approval of this file from health authorities is which allows the commercialization of the medicine.
In consequence, a modification that, at first, could seem unrelated to the medicine (such as implementing a new software, installing a collaborative robot, implementing a artificial vision system or modifying a productive operation) could affect to processes previously validated that are part of the documentation presented to regulatory bodies.
These type of changes requires the development of risks analysis, qualification and validation activities previous its implementation, the updating of documents and, also, the processing of regulatory modifications.
In other words, at the pharmaceutical industry is not enough with introducing a technological improvement. It is necessary to demonstrate with documents that the change is justified, evaluated, validated and control, so that the medicine compliant can be maintaines during its life cycle.
For that reason, any change implies a significant investment of time, resources and costs for the pharmaceutical companies. The greater is the potential impact on a process or a registered product, higher would be the effort required to implement that innovation with all the guarantees.
The need of innovation spaces pre-GMP
The GMP environments are design to guarantee the most robustness, traceability and control of the productive processes. Precisely for that reason, not always constitute the most adequate scenario to experiment with emerging technologies or develop concep test in its initial phases.
Innovation requires of creativity, capacity to explire different approaches, flexibility to experiment and margin to iterate about different technological alternatives before reaching a sufficiently mature solution for its industrial implementation.
It is precisely on that point where technology centres contributes a differential value.
Pre-GMP enviroments allows to evaluate new technologies, validate concepts, quantify benefits and reduce technical uncertainities before facing the demanding pahes of validation and implementation on a regulated environment. In this way, comapnies can take decisions with a more solid technical base and minimize risks associated to the incorporation of new solutions.
CARTIF´s contribution to the pharmaceutical innovation
CARTIF can contribute to the pharmaceutical innovation in three strategic ambits:
Innovation in processes and products
The optimization of chemical and biotechnological processes, the industrial scale and the improvement of productive operations continue to be priority fields for the pharmaceutical industry.
Operations such as extraction, spray drying, fermentation or chemistry synthesis continue offering a wide margin for innovation. At the same time, these more classical technologies live with other challenges associated to development and manufacture of advances therapies, such as genetic, cellular and tissular therapies, that plan new tehcnological and productive needs to which from CARTIF we have to look.
Industry 4.0 for smarter production
New technologies offer important opportunities to improve the efficiency of processes without the need of step in directly over productive systems already validated or work on not accessible environments for product or operator protection
Technologies such as digital twin, artificial intelligence, artificial vision, advance analytic, collaborative robotic or augmented reality allows optimize the decision-making, reinforce the support for the operation and improve the efficiency in those environments where the accesse to the process is limited or where any direct intervention involves a high degree of complexity, as is the case in the aseptic manufacture of sterile products or high-potency products such as hormonal or cytotoxic agents.
Sustainability and energy efficiency
Optimising resource use, improving energy efficiency and developing circular economy strategies represent an opportunity to simultaneously enhance both the environmental sustainability and competitiveness of pharmaceutical companies.
The implementation of solutions that reduce the energy consume, minimize the residues generation and promote a more efficient use of the resources allows advance through more sustainable productive models without resign to high quality standars that requires the sector.
CARTIF: innovate in non GMP environment, but thinking on GMP
The activity we develop at CARTIF is focused mainly in the stages leading up to industrial implementation and regulatory validation processes. However, working on pre-GMP environment doesn´t mean working aside from the requirements that will condition the future development or implementation of the technology.
Our role is help pharmaceutical and biotechnological companies to explore new solutions, validate emerging technologies and reduce the technical uncertainty before facing the complex stages of implementation on a regulated environment.
Because, although we work before GMP, we innovate thinking on an environment where our knowledge of the sector and its practices are essential so that any innovation could reach the market.
From CARTIF we not only act such as applied knowledge generators, but also as catalysts for innovation ecosystems that boost the development, validation and adoption of new technologies by the pharamceutical industry.
A technological ally for pharmaceutical innovation
From CARTIF we understand the innovation such a process focused on generate useful, applied and transferable knowledge. Pharmaceutical industry needs spaces to experiment with the flexibility needed to transform new ideas on viable industrial solutions, without losing sight of the regulatory requirements that will condition their future implementation.
Because, in a sector where operational excellence is inextricably linked to regulatory compliance, innovation requires a combination of creativity, scientific knowledge and industrial vision. Having environments in which to develop and refine new technologies before their implementation under GMP conditions constitutes a strategic advantage for reducing risks, accelerating technological development and facilitating the bringing of innovation to market.
In a context where any changecould can have impact on the registration of a medicine, innovating prior to GMP doesn´t mean innovating aside from GMP, but rather doing so with GMP in mind from the outset.
👉 If your company is exploring new technologies to optimise pharmaceutical processes, carry out R&D projects or prepare for future GMP implementations, at CARTIF we can help you validate solutions and mitigate technological risks.
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