advanced manufacturing Archives - European Industrial Pharmacists Group (EIPG)

The EU Parliament voted its position on the Unitary SPC


by Giuliana Miglierini The intersecting pathways of revision of the pharmaceutical and intellectual property legislations recently marked the adoption of the EU Parliament’s position on the new unitary Supplementary Protection Certificate (SPC) system, parallel to the recast of the current Read more

Reform of pharma legislation: the debate on regulatory data protection


by Giuliana Miglierini As the definition of the final contents of many new pieces of the overall revision of the pharmaceutical legislation is approaching, many voices commented the possible impact the new scheme for regulatory data protection (RDP) may have Read more

Environmental sustainability: the EIPG perspective


Piero Iamartino Although the impact of medicines on the environment has been highlighted since the 70s of the last century with the emergence of the first reports of pollution in surface waters, it is only since the beginning of the Read more

How AI is Changing the Pharma Industry and the Industrial Pharmacist’s Role

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Svala Anni, Favard Théo, O´Grady David

The pharmaceutical sector is experiencing a major transformation, propelled by groundbreaking drug discoveries and advanced technology. As development costs in the pharmaceutical industry exceed $100 billion in the U.S. in 2022, there is a pressing need for innovative solutions to accelerate drug development. The urgency stems from a renewed focus on novel approaches, driven by the complexities of advanced therapeutic modalities like mRNA, CGT, and synthorins. This blog delves into the influence of Artificial Intelligence (AI) on overcoming the unique hurdles within the manufacturing domain of the pharmaceutical industry. It specifically emphasizes the crucial partnership between AI and human expertise, shedding light on the vital role of industrial pharmacists in optimizing manufacturing processes.

The demands for precision, quality, and compliance in pharmaceutical manufacturing present challenges, notably in managing rising costs and intricate logistical processes. The adoption of various AI technologies, including generative AI (GenAI), represents a strategic shift, aiming to augment human capabilities while automating routine tasks and facilitating knowledge transfer in the ever-evolving landscape of pharmaceutical production

The fourth industrial revolution is upon us with the development of cyber physical systems and the fifth industrial revolution is on the horizon with the advancement of artificial intelligence (AI) in partnership with humans to enhance workplace processes. The factory of the future is here with digitalization, AI, Big data, robotics and advanced manufacturing becoming the norm rather than the exception in the pharmaceutical industry.

GenAI excels in promoting collaboration while surpassing traditional task automation. It is key in transmitting complex knowledge crucial for maintaining quality, compliance, and safety in pharmaceutical manufacturing. AI empowers experts to document processes using everyday devices, transforming this raw data into straightforward, visual instructional guides.

The pharmaceutical industry confronts distinct manufacturing challenges, including complex processes and rigorous regulatory standards. AI can offer several innovative and compliant solutions. In addition, AI platforms swiftly update training materials, creating dynamic learning environments that keep the workforce informed about the latest developments. These platforms are redefining roles by taking over mundane tasks, thereby freeing human workers to focus on more strategic and creative roles. Furthermore, AI guarantees uniform training across global operations, ensuring consistent processes and fostering global standardization.

Combining humans and AI creates a powerful team that may benefit everyone. AI helps make learning experiences unique for each person, fitting their own way of learning. It also makes it easy for people to get the information they need anytime, thanks to the latest tech advancements. AI is great at helping people from different cultures and who speak different languages work together better. It can give feedback right away, so mistakes don’t spread. Plus, AI holds onto valuable knowledge, reducing the chance of losing important information when people leave or retire. Together, all these benefits show how AI can make a big, notable change also in the pharmaceutical field.

AI – Shaping the Future of Pharmaceutical Industry

AI is transforming the pharmaceutical landscape, particularly in areas vital to industrial pharmacists, such as manufacturing, quality control, and distribution. These professionals play a pivotal role in skillfully integrating AI, serving as the human-in-the-loop to enhance efficiency and ensure safety in pharmaceutical operations.

AI elevates the manufacturing process, forecasts maintenance needs, and sharpens quality control. Industrial pharmacists are pivotal in deploying these AI-driven techniques, ensuring that operations are not only effective but also meet high-quality standards and regulatory requirements.

The Role of Industrial Pharmacists

Industrial pharmacists are essential contributors to this technological revolution, actively collaborating with data engineers and scientists. They play a pivotal role in ensuring regulatory compliance, upholding product quality, and leveraging AI to enhance drug development processes, inventory management, and distribution. Industrial pharmacists:

  • are essential in incorporating AI into manufacturing workflows.
  • ensure AI tools align with regulatory requirements and uphold product quality.
  • utilize AI to accelerate and economize the drug development process.
  • leverage AI for more effective inventory and distribution management.
  • analyze data generated by AI systems for informed decision-making in production and quality control.
  • ensuring the quality of pharmaceutical products, they play a crucial role in safeguarding patient safety.
  • leverage AI to identify eco-friendly manufacturing practices, contributing to sustainable pharmaceutical production.

Risks and Challenges

Using AI in the pharmaceutical environment involves navigating risks such as ensuring data privacy and security, maintaining regulatory compliance, addressing biases and ethical concerns, and dealing with the quality and reliability of data. Additionally, there are challenges related to intellectual property issues, integration with existing systems, scalability and maintenance, and dependence on external vendors. To effectively leverage AI benefits while minimizing these risks, a comprehensive strategy encompassing robust data governance, ethical AI practices, ongoing regulatory engagement, and careful technological and organizational change management is essential.

Conclusion

The pharmaceutical industry stands on the brink of a transformative era, driven by the profound potential of AI to reshape its landscape. The key to unlocking this potential lies in the proactive involvement of industrial pharmacists, who are urged to assume a more strategic and leading role in steering innovation.

Traditionally perceived as followers, industrial pharmacists now face a pivotal moment to transition into drivers of change. This isn’t merely a shift in perception; it is a call to action. The integration of AI offers a unique opportunity for pharmacists to shape the future of pharmaceutical care actively and courageously.

In this evolving landscape, industrial pharmacists are not just guardians of compliance but architects of efficiency, adaptability, and innovation. Collaborating seamlessly with AI technologies, they hold the power to propel the industry forward. Despite certain challenges, this collaboration looks promising – it isn`t just compliant and efficient but also dynamic and inventive.

The call to action is clear – pharmacists, especially those in industrial roles, are not merely spectators in this technological revolution; they are the forerunners, charting a course towards a more responsive and innovative pharmaceutical future.

References:

Artificial trends: intelligence in the pharmaceutical industry: analyzing, innovation, investment and hiring

Insights to the Industrial Pharmacist role for the future: A concept paper from EIPG Advisory Group on Competencies, vol 2, 2023

Pizoń J, Gola A. Human–Machine Relationship—Perspective and Future Roadmap for Industry 5.0 Solutions. Machines. 2023; 11(2):203.

Zheng, S. (2023, Nov. 2). “Empowering the pharma workforce.” Pharma Manufacturing.

Contact for further information:
Anni Svala, Vice-President for European Affairs, European Industrial Pharmacists Group, [email protected]


EU’s Industrial Forum, the future of advanced manufacturing technologies

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by Giuliana Miglierini

The expert group “Industrial Forum” is a multistakeholder body created by the European Commission to support the implementation of the Industrial Strategy launched in March 2020 and its following update of May 2021. Its members include Member States authorities, NGOs, industrial representations, research institutions and social partners representing different industrial ecosystems.

Its recently published report is the result of the structured dialogue among members on how to accelerate the deployment of advanced manufacturing technologies (AMTs) across the European industry. Among members which participated in the drafting of the document is also EuropaBio on behalf of the biomanufacturing industry.

Europe is leader in advanced manufacturing

Advanced manufacturing is based on the integration and convergence of the most advanced industrial technologies, i.e. automation, robotics, artificial intelligence and digitally connected solutions. New processes, new products as well as new business models based on this new approach are deemed to represent a fundamental competitive factor in the next few years.

Europe is currently well position in the ranking on “future of production” readiness, with 18 out of 25 countries considered by the World Economic Forum to be leading the change in manufacturing. Despite this, according to the report many efforts are still needed to accelerate the implementation of advanced manufacturing technologies in the EU, so not to be superseded by other fast-evolving competitors.

In order to achieve this challenging goal, the Industrial Forum identified seven different areas of attention, each of which is addressed by specific recommendations based on a SWOT analysis.

The seven areas of recommendation

The transition to new manufacturing models should, first of all, meet the EU sustainability goals established by the European Green Deal: the “net-zero industry” plan for renewables and industrial efficiency technologies is confirmed as a priority action, together with the expansion of the use of REPowerEU. The Commission is working on new energy savings directives, which should be timely implemented. Circularity of manufacturing processes and products is another main goal of EU’s industrial policies, to be supported by a set of new fit-for-purpose rules. A more rapid uptake of advanced manufacturing technologies should also be supported by both the availability of specific public procurement guidance and a targeted communication of the environmental benefits of European clean technologies.

The second area of action addresses how to improve access to capital, a key factor in ensuring the timely implementation of advanced manufacturing technologies. This may include a better use of public investment, as well as a cautious application of state aid instruments specifically targeted at later stages in the innovation and deployment process. The potential of these new technologies for sustainability should also be recognised within the upcoming EU Taxonomy de-legated acts.

The resilience of supply chains could be tackled by the rapid implementation of AMTs. In order to achieve this goal, the Industrial Forum highlighted the need for workable and proportionate rules on Due Diligence. No less important is the negotiation and activation of new Free Trade Agreements with third countries (such as the EU-Mercosur FTA). A critical area refers to the improvement of EU semiconductor capacity. According to the report, incentives and funding aimed to increase the supply chain resilience should be exempt from directing specific outcomes. The European institutions should also better support the local and regional industrial supply chains. Secure access to critical raw materials should be pursued by leveraging the trade policy.

The building of an EU Single Market is a main goal of the European Commission, also in the pharmaceutical field. Its freedoms should be safeguarded by narrowing down the scope of the Single Market Emergency Instrument, while promoting mitigation measures for advanced manufacturing. The Industrial Forum also recommends the availability of a single platform to provide companies with all the needed information to expand and/or export. Furthermore, a Single Market test should be included in the impact assessments of national laws to minimise the occurrence of gold-plating phenomena. New standards for AMTs would also be needed, an area which according to the Industrial Forum should conjugate an enhanced flexibility in standardisation requests and timely delivery in standard setting. Digital product standardisation should also be promoted, and adhesion to the New Legislative Framework should be ensured.

Data is a fundamental asset of the new economy. Recommendations in this area include supporting existing initiatives to create a strong European manufacturing data space, as well as ad-dressing the protection of both personal data and intellectual property rights and trade secrets. As artificial intelligence (AI) will assume an increasingly relevant role in future advanced manufacturing processes, the Forum recommends the development of clear, focused criteria on high-risk AI, while avoiding unnecessary regulation of industrial AI.

The availability of data should be pursued through the identification of a method for data collection in the advanced manufacturing category. It would also be important to generate trusted data sets at the European level for advanced manufacturing deployment, global competitive position, and economic / environmental / societal gains.

Many new skills will be needed in the next few years to handle the expansion of AMTs. To this instance, the Industrial Forum highlighted the importance to promote the harmonisation of Vocational Education and Training (VET) practices and qualification systems and to encourage women and girls to study STEM subjects and working in manufacturing. Other recommendations re-fer to the possibility of developing a Pact for Skills partnership and the proposal of a Blueprint Alliance for Advanced Manufacturing. A better entrepreneurial culture in Europe should also be promoted, as well as capitalisation on European creative industries.

Examples of biomanufacturing

Weaknesses to biomanufacturing identified by the Industrial Forum include the fact that it is still an emerging production process compared to chemical manufacturing. The report also mentions existing regulatory barriers, mainly linked to a process rather than product approvals pathway. Furthermore, significant investments in biomanufacturing are primarily located outside Europe. Possible risks identified by the report also refer to biomanufacturing being excluded or overlooked in key policymaking e.g. taxonomy supporting biomanufacture and sustainable financing.

The report includes two examples of AMTs linked to the health and agrifood sector. Chimeric antigen receptor T cells (CAR-T) represent one of the main areas of innovation in cancer treatment over the past two decades, in which the patient’s immune cells are engineered to produce the final immunotherapy. Many pharmaceutical companies are building specialised manufacturing facilities for CAR-T therapies within Europe, a biomanufacturing process which is highly complex and patient-specific, and requires long term investments, skills development, and integration into the European Union industrial base.

Biomanufacturing may also be applied to the production of vitamin B2 (riboflavin), that multi-step chemical synthesis is complex, requires hazardous agents and has low yields (~60%). Biotechnologies allow for the one-step production of vitamin B2, starting from vegetables as carbon sources and using a genetically modified bacterium (Bacillus subtilis) or fungus (Ashbya gossypii).