The 2023 ISPE Biotechnology Conference in Dublin from 26-27 June 2023 will give an overall view of development and manufacturing for biologics.
For the current products of first-generation biologics, like mABs or vaccines, the challenges to increase productivity, process intensification, flexibility, and agility are distinctive when it comes to mass production. The conference will present and discuss modular facility design and collaborative project delivery.
For the innovative products of second-generation biologics, like cell and gene therapy, Advanced Therapeutic Medicinal Products (ATMPs), and mRNA-based products - such as vaccines, the focus is on different challenges. The conference will present and include presentations with a focus on time to market, shortened submission approval times, product transfer, new concepts for control strategy, quality oversight, manufacturing, and logistics.
The 2023 ISPE Biotechnology Conference will focus on the overarching themes that represent learnings from the first-generation products that can be applied and transferred to the (new) second-generation products. Methodological enablers for process development, supply chain resiliency, and more critically, driven by the energy crisis, sustainability will be the main focus of our event. The discussions will be presented and considered within the current regulatory framework.
The conference will provide a leading interdisciplinary platform for all stakeholders of the pharmaceutical and biopharmaceutical value chain to present recent innovations and trends, and openly discuss practical challenges and solutions, from a technical, logistical, and regulatory perspective.
The impact of the evolving regulatory environment and the need to ensure continued innovation and continuity of the supply chain, considering the current energy crisis and assuring preparedness for future crises, will be integrated throughout the conference programme and panel discussions. Participants will have the opportunity to engage with industry leaders, regulators, and peers through networking events and the conference programme.
Given the impact of the evolving pandemic, an aging population, the increase in diseases with unmet needs, and an unprecedented rise in chronic diseases, the need for a constant focus on collaborative innovation and agility will shape Pharma’s priorities in the foreseeable future. ISPE will be the leader to set the pace for knowledge sharing that speaks to the current and future needs of the industry.
The 2023 ISPE Biotechnology Conference reviewers are requesting proposals aligning with the following content areas:
While the advantages that come with digital transformation are well recognised by the Biotechnology industry, the challenges of starting on the digitalisation journey cannot be underestimated. To see the gains in profitability, productivity, and accelerated delivery that comes with digital transformation, collaboration is required across teams working in facilities design, equipment selection and validation, technology transfer, manufacturing operations, Quality Assurance, and Regulatory Authorities. The digital transformation track will feature case studies and road maps from various perspectives – addressing the niche challenges faced in digitalising large scale Generation 1 biotech production to CMOs producing novel therapeutics.
Addressing supply chain vulnerabilities and increasing the sustainability focus are now high on most companies’ agendas. The last years' disruptions and developments caused by the pandemic, geopolitical issues, and the development of 2nd generation drugs all require a new and more agile approach to supply chain management. This track will focus on and give examples of how we as an industry can act to be prepared, avoid unnecessary drug shortages, and ensure that the momentum we have seen with regard to drug development, clinical trials, and ESG initiatives is maintained and improved.
Manufacturing of ATMPs (Cell and Gene therapies) will be more integrated than in the past to design from the proof of concept to the GMP-compliant commercial manufacturing. There are over a thousand ATMPs in pre-clinical and clinical trials. The manufacturing design of those new therapies does need to be designed in at an early stage to check if the manufacturing process is suitable for commercial manufacturing. Another important aspect to consider is if scale up or scale out is the better approach and centralized vs. decentralized manufacturing. During this session, we will focus on the manufacturing requirements and how to design the process and facility for GMP compliance. How will the new EU GMP Annex 1 and PIC/s Annex 1 for sterile Manufacturing impact the design of the facilities for Cell and Gene Therapies? How do you get ready for your Cell and Gene Therapy commercial manufacturing?
Obviously, Gen 1 Products (mAbs, other protein therapeutics, and traditional vaccines) and Gen 2 Products (ATMPs such as Cell and Gene Therapies, mRNA vaccines, and other cutting edge modalities) have different maturity levels, such as the development and application of platform manufacturing processes. However, what are the common methodological enablers, potential crossfertilizing workflows, and good practices to apply those methods? Both generations of products need to develop a control strategy. While in Gen 1 the business goals may focus on transferability, scale-up, and process optimization, in Gen 2 we need to include the inherent variability of the starting raw materials and unique unit operations (such as cell processing) to ensure product and process robustness and performance over the lifecycle. Therefore, this track focusses on providing answers and food for thought to the following questions: What are the workflows to get to manufacturing process and product platform understanding? How to formulate a holistic process control strategy? How can digital twins and its interplay with PAT help? In what areas do differences between Gen 1 and Gen 2 products and processes justify distinctly different approaches?
After the recent popularity gained by mRNA technology with the Covid vaccines, we started to realize the impact and the boost it had in this field as well as for the oligonucleotides. The objective of the session is to explore RNA beyond the mRNA manufacturing process and vaccine applications. It involves discovering other types of RNA with therapeutic applications to exploring the manufacturing of the plasmid or DNA template prior to the in-vitro transcription. In front of us, we have a steep learning curve to understand the diversity and the specifics of the manufacturing chain that make this new generation of RNA drug products totally different from traditional biologics (e.g., mAbs) or other ATMPs (e.g., cell & gene therapies).
The Covid-19 pandemic has highlighted the need for expedited delivery of pharmaceutical manufacturing facilities more than ever. The goal is to shorten the time between lab benchtops and the marketplace. How can pharmaceutical facilities be constructed faster than ever to meet market demand while adhering to cGMP standards and not compromising on quality?
Speed to market is an uphill challenge for drug manufacturers who are racing to deliver on the success of their development efforts. In order to quickly deliver approved therapies to patients, full-scale commercial production under accelerated time frames becomes a priority.
As an alternative to traditional stainless-steel single process manufacturing facilities, the industry is evolving towards scalable, flexible, and modular facilities, to name a few. The use of these technologies has demonstrated that small but outwardly scalable flexible facilities can be constructed, commissioned, and validated in much less time than half the typical 4 to 5 years for a traditional plant.
In this track, participants will explore the promising future of agile manufacturing methods coupled with well-governed, transparent and collaborative project delivery models to facilitate project delivery in expedited timelines and with higher certainty.
20-minute presentation, to be made part of a larger session by the Planning Committee. The presentation should focus on new and innovative trends, a specific real-world strategy or campaign, case study/use case, a “how-to" presentation intended to help attendees gain a better understanding of the initiative and best practices that can be applied to day-to-day objectives or overall mission.