Single-Use Technology Standardization - A Case Study

Jan 29, 2024 1:45pm ‐ Jan 29, 2024 2:15pm

Identification: SES101

Using a recent case study as the basis of this presentation, the presenter will outline the tools and methodology used to start the journey towards standardization. With numerous sites across a global network of facilities, this may seem a daunting task. However, using a systematic approach and clear and consistent process mapping, the “as is” status can be clearly visualized, and opportunities for standardization identified.

Having identified these standardization opportunities, the presentation will look to the various vendor and industry standard options available, before outlining the solution chosen in this recent example. The main benefit that the case study will highlight is the simplification of the assembly designs so they can easily be used across different sites and/or processes, with an overall reduction in the number of Stocking Keeping Units (SKUs) in the overall network.

Sustainability in Facility Design

Jan 29, 2024 1:45pm ‐ Jan 29, 2024 2:15pm

Identification: SES201

This presentation will explore Johnson & Johnson’s strategy for reducing scope 1 emissions at their facilities, with a focus on heat pump applications in existing facility retrofits and new facility design.

NIH Center for Alzheimer's Research and Speed to Open

Jan 29, 2024 2:15pm ‐ Jan 29, 2024 2:45pm

Identification: SES102

The National Institute of Health (NIH) had an imminent need to support the National Institute of Aging (NIA) and its Alzheimer's Disease and Related Dementias (ADRD) research. This approximate $34M project was built to NIH Design Requirement Manual (DRM) guidelines. The speed to open was driven by research need but there was no space available on the Bethesda, MD campus to accommodate. Due to the urgent need for Alzheimer's and related dementias research, the design-build team executed and delivered on a prescribed modular design. Deciding to construct this innovative, state-of-the-art facility with pre-manufactured modular units allowed the project to be designed and delivered on-time and on-budget, in under two years. Individual modular units were manufactured in a factory in Leesburg, Florida and shipped to Bethesda for on-site installation. Once assembled, final interior finishes, exterior cladding, and MEP systems were installed on site. The completed, award-winning facility is made up of 65 modular units and includes 12,000 SF of laboratory space and 9,000 SF of supporting office space.

Clean by Design - for Efficiency and Sustainability

Jan 29, 2024 2:15pm ‐ Jan 29, 2024 2:45pm

Identification: SES202

An introduction to the ASTM E55.11 Clean by Design work item for the specification, manufacture and test of pharmaceutical and biopharmaceutical manufacturing systems that are rapidly and robustly CIP-cleanable.

The adoption of the simple CbD approach offers improved manufacturing efficiencies due to reduced cleaning times and dramatically reduced water usage. The water used for cleaning is generally produced by distillation, so energy usage is also reduced pro rata.

Efficiency data for 41 facilities is included in the presentation (including the current lengthy cleaning times), together with energy usage for one bioprocessing facility (41.7% of total energy used is to produce and heat water for CIP cleaning).

Current overkill CIP cycles using aggressive chemicals result in deterioration of "soft parts" which can cause contamination/cross-contamination issues - or result in substantial maintenance time, cost and residues.

Clean by Design started as a checklist of technical recommendations, but much of the content is now based on ensuring users clearly state what they require to equipment manufacturers.

A Flexible & Future Proof cGMP Facility for the Unknown

Jan 29, 2024 2:45pm ‐ Jan 29, 2024 3:15pm

Identification: SES103

This presentation will cover the exciting new project designed for the Roche Cell & Gene Therapy network. The Genentech Cell Therapy project for a new state of the art production suites was recently completed and designed to be a flexible and future proof cGMP facility that allows for multiple product development and manufacturing. The facility design and engineering includes infrastructure & utility systems that will allow for multiple product types including cell therapies. The new facility is also organized to support products across all stages of development including, analytical development, manufacturing science & technology (MSAT) development, and clinical manufacturing. The new facility has been mastered planned with the ability to grow as needed to support future products such as medias, plasmids production, and related genomics products by building out internal shelled spaces and to grow its footprint while maintaining a fully functional and operating facility. Some products that the facility is designed to house are Plasmids, RNA, DNA, T-cell, and HESC's. The Cell Therapy project finished construction in June 2023 to support Start-up Operations from July to October 2023.

Sustainability Assessement on CU - Method & Case Study

Jan 29, 2024 2:45pm ‐ Jan 29, 2024 3:15pm

Identification: SES203

In the last five years, global industry and in particular the pharmaceutical industry has been witnessing an important transition on sustainability and the digitalization fields.  In particular, the clean utilities are one of the focus areas experiencing the greatest discussion as it is one of the largest consumers of energy and water.  New technologies and process solutions go hand in hand with the improvement of existing systems with the common goal of using energy and water more efficiently as water is a resource which today has become very rare in many areas of the world.  This presentation aims to show an overview of sustainability in clean utilities for the Facility of the Future-As a supplier of clean utilities systems, we will address end user needs in term of more sustainable technologies and process solutions.  A consolidated method called Sustainability Assessment will be described, which aims to analyze new or existing clean utilities systems and identify solutions to improve sustainability in a cost-effective manner; all contextualized to site and geographical area conditions through a holistic view of the system.  In addition to presenting the main steps of the assessment, a real case study will be shown done for a big pharma company.

Rapid Drug Substance Facility End 2 End Modular Delivery

Jan 29, 2024 4:00pm ‐ Jan 29, 2024 4:30pm

Identification: SES104

Covid-19 pandemic has shown the need for immediate reaction of CDMOs and big pharma to rapidly expand production capacities of still unknown products, which can only be narrowed down to platform processes. This presentation is answering demand for pandemic preparedness of single countries and Europe & CDMOs possible reaction for rapid supply of mRNA. Flexibility in terms of product type, change over and process transfer as well as eye-on-eye level partnerships in supply chain, contract forms and project execution. Design & Build industry´s tweaks to react to rapid timelines using achievements from the last decade such as modular design, plug & play equipment, module type package automation and emerging technologies such as digital twins, AI based construction surveillance and VR training. Also, operational challenges, such as seamless compliance for EHS and GMP while hiring and training highly qualified staff in a time of war for talent.

Gilead’s La Verne’s Energy Reduction Experience

Jan 29, 2024 4:00pm ‐ Jan 29, 2024 4:30pm

Identification: SES204

Gilead’s La Verne’s Energy Reduction Experience, realized by specifying AHU Filters with Higher Energy Ratings, and what it means for Other Pharmaceutical Manufacturers

Designing a Gene Therapy Factory That Flexes for the Future

Jan 29, 2024 4:30pm ‐ Jan 29, 2024 5:00pm

Identification: SES105

By definition, Gene therapy technology and manufacturing is constantly evolving, which presents unique challenges in terms of facility design, coupled with ongoing shifts in platform, process and capacity. Spark Therapeutics has designed -- and is already in the process of constructing – one of the world’s largest new gene therapy manufacturing facilities in the heart of University City in Philadelphia. The design of the innovative facility ensures that Spark is able to accommodate ongoing changes in both technology and manufacturing, while at the same time fully engage the local Philadelphia community and ensure a positive local impact. Designed to flex for future needs, Spark’s Gene Therapy Innovation Center will be a state-of-the-art facility with inherent sustainability that will surely serve as a model in the industry for many years to come.

Powering Biotech: Inside an All-Electric Facility

Jan 29, 2024 4:30pm ‐ Jan 29, 2024 5:00pm

Identification: SES205

For many in biopharma, sustainable operations seem like a distant, expensive, or lofty goal without a clear plan or priority. But not for all. A few in the industry are already reaping the benefits from designing with sustainability in mind. Allogene’s fully electric, solar-powered, zero-water central plant, 136,000 sq ft, CAR T manufacturing facility has been operational for over a year. So, is it a win? What is the theoretical vs. actual power generation and utilization, and is going green worth it? Industry experts George Scott, Senior Director of Facilities & Engineering at Allogene and Jeff Wegner, Energy & Sustainability Fellow at CRB, discuss how this state-of-the-art plant was designed for sustainability and why it makes good business and operational sense. The duo will discuss the strategies employed at the site and dig into real-world operations data against design expectations and industry standards to demonstrate the tangible wins of a greener facility. Sustainability goals are within your reach and more budget-friendly than you might think.