To secure product supply many different control strategies are implemented. However, these are rarely connected so a change to one control strategy may impact another control strategy in an unforeseen way. The Holistic Control Strategy connects the different CS elements across the entire supply chain to secure a robust end-to-end manufacturing process delivering speedy, reliable, consistent quality products throughout the entire product lifetime. The implementation of the HCS requires different capabilities related to digital, analytical, process, quality, and organisational maturity. This presentation will define and discuss the role of the Holistic Control Strategy and the capabilities required for successful implementation.

Regulatory framework for ATMPs as described in Eudralex Volume IV Part IV - GMP requirements for Advanced Therapy Medicinal Products and the PIC/S Annex 2A. What are the expectations of EU GMP Inspections in the field of ATMP manufacture and the manufacture of viral vectors. Do we need further detailed guidelines or can every new innovation be covered by existing framework and quality risk management approaches.

Adapting an innovative platform technology from the automotive industry, we established TIGER, a new tool to manage Drug Discovery projects. It provides project teams with a broad variety of project management capabilities to flexibly manage their projects and provides a single source of truth data source for portfolio management. TIGER is an abbreviation for Transparency, Innovation, aGility, Empowerment and Responsibility - and this perfectly describes the underlying philosophy - the system is built to establish a culture of trust, mutual empowerment and collaboration.

Circular economy thinking is edging into industries across the board. But can it work for pharma, too? Two Danish industrial symbiosis demonstrate that it can – but it requires a change in mindset and totally new ways of working together. More and more pharma companies are placing sustainability at the top of the agenda and introducing various green or sustainable initiatives. But to drive true sustainable growth and innovation, pharma needs to embrace circular economy thinking. A circular economy is based on the principles of designing out waste and pollution, keeping products and materials in use and regenerating natural systems. A circular economy seeks to rebuild capital, whether this is financial, manufactured, human, social, or natural. This ensures enhanced flows of goods and services. Symbiosis is the more concrete manifestation of circular economy. The concept of “symbiosis” is usually associated with relationships in nature – thus called a natural symbiosis – where two or more species exchange materials, energy, or information in a mutually beneficial manner. If you replace “species” with “companies” in the sentence above, you basically have an industrial symbiosis. The biggest potential for industrial symbiosis lies in bringing down the costs for raw, processed materials and waste through better use of existing technologies. But is it even feasible that the pharma industry – which is notoriously known (and rightly so to a large extent) to be rigidly regulated and with limited opportunities for changing resource consumption and, in turn, emission – can go circular? Sceptics may say that circular economy is not relevant for pharma and biotech. There is, however, two Danish examples of symbiosis involving companies from the pharma industry which with their great success and international recognition, prove those sceptics wrong. It’s clear from the cases that there are a lot of benefits to be accrued from industrial symbiosis – both on company level, on local level and on a broader socio-economic level. Both Kalundborg Symbiosis and Symbiosis Hillerød include both world-leading as well as small companies, and all of them – regardless of the size – point to benefits such as: • Lower costs for raw materials and waste handling • Improved competitiveness • Higher robustness against market fluctuations • Reduced consumption of natural resources • Lower emission of CO2 In Symbiosis Hillerød fx, the members also talk about joint solutions to challenges concerning wastewater, infrastructure, workforce and education. Thanks to the symbiosis, the companies can form a united front, which makes it is easier to do something about those challenges. This also means that success is not (only) measured on individual company level, but on a broader scale. In conclusion, the mission for any symbiosis should be to think beyond own operations. It’s the community before the individual. That is the mind-set that enables huge pharma companies like Fujifilm Diosynth Biotechnologies and Novo Nordisk to work together to drive growth and innovation. So, what does it take for pharma to go circular? First and foremost, it requires that company decision-makers recognize the potential gains of the symbiosis. And secondly, that they can establish a cooperation with another company. A range of examples of Symbiosis is presented: The Kalundborg Symbiosis, Symbiosis Hillerød, a new potential Symbiosis in Ballerup, the danish national Symbiosis network – all includes pharmaceutical industries. In addition, some examples of more generic tools are presented which can support the establishment and operation of symbiotic networks.

The availability and regular use in the pharmaceutical industry of advanced aseptic technologies that enables compliant and effective aseptic manufacturing is well understood and documented. With Cell Therapy (CT) manufacturing there is in many cases an element of 'Back to the Future' with the extent of manual aseptic processing involved to deliver the compliant and effective manufacture of leading edge therapies of today. The Takeda (Dublin) cell therapy facility was commissioned in 2019 and received its Manufacturing License from the Health Products Regulatory Authority in 2021. A facility expansion is currently under construction. This is the first approved commercial CT facility in Ireland. This presentation describes the development and evolution with respect to controls effectiveness of a robust contamination control strategy (CCS) from early facility design to commercial manufacturing for the manual aseptic processes. In addition, the presentation will address how the CCS was effectively used to input into the design of the facility expansion currently under construction.

Good planning is the prerequisite for a successful project: the technical developments of planning (from paper to AutoCAD and on to BIM) as well as the modern LEAN methods for coordination and management determine a project’s success in today’s business world. This highly relevant topic as well as the evolution from General Planner to EPCM Planner, engineering with BIM and LEAN Project Management Office will be highlighted in the speech and supported by case studies.

Although the principles of computer validation and compliance are well established, their practical application can be challenging. Good intentions can quickly lead to inefficient and ineffective ways of working. This presentation covers new GAMP guidance on Critical Thinking to optimise validation and compliance. keeping mindful of the quality of finished medicines, patient safety and regulatory compliance. Learn how to get the most of quality assurance and management within the context of the holistic business process being supported.