The opening session will take a high-level look ahead at global pharmaceutical manufacturing and related regulatory systems. We will discuss how COVID has impacted our business and the applications of future manufacturing operations and the facilities required to adequately produce product that is safe, cost effective and meets the needs of the patients we serve. Key industry leaders will share their perspectives and their insights into how they see the industry changing as we move forward from COVID.
Historically, industrial manufacturing has advanced from mechanization to mass production and then to automation/computerization. The next phase of manufacturing (referred to as Industry 4.0) involves integration of equipment and communication systems. The pharmaceutical industry is undergoing these same transformations (with the most recent phase referred to as Pharma 4.0). This session will explore aspects of Pharma 4.0 including IoT based technology and analytics, robotics in pharma manufacturing, a data mindset. This will include: The vision to integrate data and to easily visualize and analyze data providing insights across sites The future of pharmaceutical manufacturing with robots and cobots. The fundamental mindset shift to achieve a data driven decision.
Bio Manufacturing of the Future requires cost effective, scalable solutions that can be implemented quicker than the traditional stainless steel facilities of yesterday. This session explores aspects of bio manufacturing that challenge the status quo and push the boundaries of bio manufacturing as we know it. From continuous methodologies to disposable technologies, we explore the industries response to the bio manufacturing capacity challenge.
This presentation will address the ability to leverage single use technology for the rapid deployment of launch facilities independent of modality by the implementation of common platforms for process equipment, automation, instrumentation, modular cleanrooms and supporting utilities. Topics to be covered include construction strategies and design concepts for worldwide use; validation approaches allowing for optimized value; automation and data handling approaches for repeat use; and the incorporation of Cytiva formally GEHC FlexFactory(TM). Attendees will understand the importance of standardization and the value of being able to repeat a design that can be used globally; construct validation programs that address planned duplication of process and utility systems globally; understand how to reduce the time to market by utilizing standardized, modular design versus traditional stick-built construction; and the facility accommodating a wide range of SUT equipment types and sizes to maximize process flexibility to support multi-product modality.
Building new facilities can take years. We want to run the plants for decades. Supply plans changes after completing the facilities’ designs result in changes for processes to be run in the facilities. Flexibility to address potential future company needs requires facility reconfigurability. In this presentation, reconfigurable design options will cover how facilities might have capabilities for a combination of: high titer monoclonal antibody production with perfusion cell culture, low titer monoclonal antibody production with fed batch cell culture, mRNA processing, semi-continuous purification, and batch purification. We will also discuss best practice to advance Digital 4.0 with lessons learned, as many companies are advancing digital strategies for new and existing facilities. Finally, environmentally sustainable designs and designs for Employee Wellness are key to make the world a better place and attract talent: Sometimes there is synergy in the programs. In a few instances the two scorings compete against each other a little. We will discuss some recent lessons.
New facilities for the GMP manufacture of cell and gene therapies are starting to come online. This session includes presentations on two recently constructed facilities that represent the latest industry best practices in design, construction, and flexible, sustainable operation. Speed of construction is a common thread, along with innovative facility designs intended to accommodate future conditions. Join us for an informative session and the opportunity to interact with industry leaders in this segment.
As interest in the Advanced Therapy Medicinal Product (ATMP) and cell and gene therapy market continues to grow at a rapid pace, novel processes are demanding facility and technology infrastructures unlike any that have previously existed. ATMPs could transform health for many patients, and all of us involved in the field, including those of us specializing in facility design, have a role to play in helping this new era of medicine to reach its potential. This presentation will be centered around industry trends and challenges facing the ATMP industry and how the industry is working together to achieve our end goal - to get products to patients, faster. Case studies will be presented to address potential challenges designing facilities predicated on maximum flexibility, logistics optimization and technologies that reduce overhead costs, allow pipeline expandability and produce higher quality therapeutics.
It can be argued that the pharmaceutical industry is changing at its fastest rate in decades, driven in part by the requirement to manufacture new process modalities, as well as the need to deliver new facilities in a quicker and more cost effective manner. Speed to market and accelerating first-in-human has never been as important. Companies are having to respond to challenges such as increased development complexity, demand volatility, and CoG challenges as a result of increasing competition, pricing pressures and profitability. Furthermore, growing demand for more flexible and sustainable facilities, together with the advancement of new processing and Pharma 4.0 technologies, such as digitization and robotics, requires that Site Master Planning needs to advance accordingly. This session will hear about how two major pharma companies have responded to the above challenging industrial landscape. Merck KGaA will explain how they have introduced a fully continuous bioprocessing platform into a new dedicated bioprocessing centre that facilitates end-to-end convergence of Discovery, CMC Innovation, Development, and Clinical and Commercial supply. Additionally, Bayer will explain how they have adopted a Site Master Planning of the Future approach to accommodate new process modalities, delivery methods, and Pharma 4.0 technologies.
A comprehensive outlook on some of the most relevant Pharmaceutical developments in the world that are configuring a new understanding on the role of master plans. In a time of faster project delivery, evolution of process modalities, products and production processes, growing demands for more flexible processes and facilities and a shift in company objectives, the traditional modernist planning model might be transitioning to a new stage and this is the hypothesis and starting point of the presentation. We will look at the following key areas that affects how we plan and arrange our site masterplans for clients: modular design solutions; flexibility; adaptable modules; the drivers for pre-investments to assist speed to market; impact of the various modalities on support functions and designing for adaptability; impact of robotics and the integration of cobots; digitization and next generation technological developments; designing a sustainable future; well building design and creating great working environment. Our new generation of masterplanning methodology is testing renewed strategies to understand and plan sites, and by also using the intersection of the digital and physical, to display information and communicate within client organizations to help plan their futures.
The pandemic has had significant impact to industries around the world and the Pharma Industry has been no exception. Early on, the Pharma Industry responded with unprecedented speed to bring treatments to patients through collaborations, leveraging expertise and creative solutions. Today, we continue to navigate the pandemic with resilience and continued partnership. This session covers a few of these collaborations and extraordinary responses COVID-19 Pandemic.
Catalent, Inc. continues to play a strong partnership role, along with other CDMOs, in fighting the pandemic. The company’s expertise in implementing advanced pharmaceutical technologies uniquely positioned it to support biopharmaceutical companies seeking to manufacture COVID-19 vaccines and therapies. In 2021, Catalent produced over 1 billion COVID vaccines, while simultaneously manufacturing all of its other life-saving and -enhancing drugs for its customers and their patients. In this session, Catalent Chair and CEO John Chiminski will discuss key success factors, including how strong collaborations with both customers and supply chain partners, a strong focus on employee safety, and a shared purpose to defeat the pandemic, allowed the company to accelerate planned facilities expansions to help deliver vaccines in record time.
In the first quarter of 2020, As the US and the World faced an emerging pandemic, Lilly quickly leveraged its expertise in developing anti-body Therapies as potential treatments. When faced with a key challenge of capacity and speed, Lilly approached a competitor instead of the traditional contract manufacturing options to help ensure success. Amgen brought capability and responsiveness that allowed an unprecedented response and resulted in treatments available to patients in less than a year. Lilly and Amgen will discuss what allowed this partnership to be successful and deliver solutions for patients.
Hear from government authorities and industry experts on the lessons learned through the pandemic and the innovative development opportunities as a result. The panel will discuss these topics and more with questions from attendees in this town hall style session.
Biotech is adapting and evolving to have more automation, digitalization, and we need to be ready for the new challenges while continuing to break barriers in our industry. How can we use innovative technology for both personal and professional growth? What types of technologies are smart facilities using for learning? How has virtual reality transformed how we learn?
Join this think tank during the Women in Pharma® breakfast and be part of innovative group discussions to transfer new and emerging knowledge to everyone. Facilitators will encourage creative and innovative design thinking (No prior knowledge required, just creative flow) and participants will be able to contribute and share ideas on different ways, types, and areas to use innovative technology for both personal and professional growth. Ideas from each group will be submitted and shared with the Women in Pharma® community of practice. Top Ideas will be selected as part of the Think Tank pilot and participants can support idea development teams.
This session provides insights from industry experts in meeting the extraordinary challenges of pharmaceutical production and development in the COVID age. Hear about their experiences implementing new and emerging technologies and how these lessons learned can benefit future opportunities.
mRNA is not just the basis of new COVID-19 vaccines. mRNA is also a versatile technology for the development and manufacturing of new medicinal product candidates such as cancer. As cancer is also a global health threat, BioNTech aspires to develop individualized cancer treatments. The manufacturing process behind mRNA-based cancer vaccine candidates is equivalent to mRNA-based the company’s COVID-19 vaccine. The vaccine manufacturing approaches mainly differs in the required quantity, e.g. a few microgram of mRNA for the individualized vaccine candidates compared to hundreds of kilograms for a pandemic supply. The new technology allowed not only developing a new COVID-19 vaccine in a record time but also to quickly ramp-up the manufacturing facilities to supply billions of doses. The presentation will reveal key elements that make mRNA such a powerful technology and that define the facility set-up of tomorrow already today, for both: individualized medicines as well as for large volume medical products such as vaccines against infectious diseases.
This session will explore novel ways to reduce project time lines and demonstrate how PODular manufacturing will increase facility flexibility to meet potential future changing business needs. The presentation is directly applicable to flexible manufacturing facilities and responsiveness of drug supply. It will address key lead time challenges in traditional manufacturing and offer an option for manufacturing closer to the customer.