Description: Although KM was identified over 10 years ago in Pharmaceutical Industry International Guidance, the ‘what and the how’ of KM is still not well understood and adoption of KM across the industry has been slow.

In 2019, a team of Pharmaceutical Industry Practitioners came together and through ISPE, a Pharmaceutical Industry group proposed, developed, and in 2021 delivered an industry Good Practice Guide for KM. Using an existing Pharmaceutical Industry group was viewed as the vehicle for getting KM in the flow of the work for the pharmaceutical industry. This presentation will share some of deploying KM in the Pharmaceutical Industry and the approach the team took and the outline of the guidance that was developed.

Learning Objectives:

Speakers: Paige Kane, Merck & Co. Inc

Description: Common systems critical to supporting GMP operations are often left to run to fail. Cold storage refrigeration systems are specified based on performance, relying on contractors for detailed design, installation, and maintenance. Redundancy is designed in, with owners resigned to the fact that systems fail unpredictably. A similar approach is taken with compressed air generation, which is often considered a “black box.” As our facilities age, legacy piping systems are relied upon for ongoing service with limited assessment of remaining life. These systems serve critical functions in operating facilities, but are not held to the same standards as utility systems. Predictive monitoring can be put in place to monitor and alarm these systems, often at a cost that pales in comparison to the risks they help mitigate. This presentation outlines basic frameworks to implement monitoring, trending, and alarming that can be used to manage risk and prevent catastrophic failures.

Learning Objectives:

• Refrigerant and compressed air generation systems have temperature and pressure parameters/ranges that can be monitored and alarmed, just like other utility and process systems.
• Aging pressure and hazardous piping systems and vessels often continue in their service lives as the equipment is replaced. Risk-based monitoring of remaining life can be put into place with limited contracted and invasive testing.
• Given the criticality of these systems and the risks that failures present, predictive monitoring can be retrofitted without excessive cost. This can be used to help foresee and avoid catastrophic failures, increase safety, and reduce process downtime.

Speakers: Justin Pagliaro, Hargrove Life Sciences | Joe Mulato, GlaxoSmithKline

Speakers: Audrey Greenberg, Co-Founder, Center for Breakthrough Medicines

Description: Commercializing the World’s first Tumor Infiltrating Lymphocyte (TIL) Cell Therapy

Learning Objectives:

• Overview and Understanding of the TIL Therapy Platform
• A Patient-Centric Approach to Design and Construction for Personalized Medicine
• Cell Therapy Logistics – Obstacles and Solutions for Commercial-Scale TIL Manufacturing

Speakers: Justin Ondrey, Iovance | Brian Kirk, CRB | Niranjan Kulkarni, PhD., CRB | Tim Gwinn, CRB

Description: Our presentation will focus on the robust planning required to bring a high volume, high-quality medical device manufacturing facility from the earliest stages of design through construction, commissioning, qualification, and validation. Our presentation will be a case study on the B|Braun Medical facility expansion project located in Allentown, Pennsylvania. We will review key design considerations such as global network strategies, facility flexibility, unique equipment/facility requirements, and sustainability as a function of design.

Learning Objectives:

• Understand what a high-volume medical device facility does by outlining what products it makes, how they are made, and how they integrate into the overall medicine delivery landscape.
• Outline unique facility and equipment design solutions specific to high-volume medical device facilities.
• Learn how sustainability goals and objectives can be achieved even in facilities with high energy demands.

Speakers: Nate Bonar, B.Braun | Michael Lennon, IPS-Integrated Project Services, LLC

Description: The manufacture of biopharmaceutical products is a challenge because of the complexity involved with optimizing the upstream bioprocess. A historical challenge with upstream bioprocessing was the lack of inline measurements for biochemical parameters. Raman spectroscopy addresses this challenge by providing inline, real-time analysis to simultaneously measure multiple components with a single probe. We discuss hardware, software, and sampling probe advancements that enable consistent bioprocess measurements in different environments. Transferability and analytical model lifecycle are other important considerations which will be discussed. Raman spectroscopy is a technology platform that is equally powerful for upstream and downstream applications. Industrial examples demonstrate successful lab-to-process applications. Frontiers in model transfer, compatibility with miniature bioreactors, and SUBs show that Raman is a consistently powerful tool for bioprocess understanding and control.

Learning Objectives:

• The importance of in situ Raman and advantages over traditional off-line sampling will be discussed. This real-time monitoring allows for a better process understanding, and therefore allows process control to optimize nutrient feeds. This control has been shown to decrease variability, increase quality, and can detect problems in real-time.
• The capability of in situ Raman to improve product quality, increase titer and enhance volumetric productively will be addressed through industrial applications. These applications will include mammalian cell culture, fermentation and downstream bioprocessing.
• The ability and advantages of in situ Raman to scale from R&D and pilot to GMP production will be discussed. The excellent model transferability of Raman is demonstrated in the laboratory to cross-scale studies.

Speakers: John Maticchio, Eastern Controls

Description: Automated data collection is a key to the commercial launch of any ATMP. Data are needed to demonstrate process control for regulatory application filings, to demonstrate compliance with 21CFR Part 11 Electronic Records/ Electronic Signatures requirements, for process understanding and improvements by MSAT, and the integration of production results to MES/EBR systems.

Manufacturing Operations need real-time trend data and alarm monitoring of critical equipment – at a glance, and audit trail data from direct impact systems that generate electronic records or signatures.

MSAT needs process result data for continuous improvement and process understanding. This result data comes from inherently “closed” systems, that were until recently used in laboratories, were not networked, and removable media was used to manually transfer data.

So how to get this data, both real-time and asynchronous, and in various forms to the functional areas that need it, in the right format, place and time?

This presentation will take an in-depth look at how Autolus Therapeutics and their system integrator Barry-Wehmiller Design Group, Inc., are achieving compliance by meeting GMP data collection requirements. This presentation will focus on the networking of equipment from various suppliers, using various communication interfaces, for the purpose of collecting, storing, and making the data available to key end-users, decision makers, and other business systems.

Learning Objectives:

Speakers: Miranda Neville, Autolus Therapeutics | Steve Chapman, Barry-Wehmiller Design Group

Description: With continuous manufacturing, reducing overall risk is critical, and instrument reliability is key to this process. With more reliable equipment, processes that used to run for only a few days are now extending runtime to weeks and even months. Extending process runtime reduces the number of times processes start and stop and the amount of equipment downtime. Longer runtime intervals are possible with predictive and preventative maintenance. With permanent diagnostics, verification, and monitoring, process owners can check an instrument’s health status, perform in-line/in-situ verifications and calibrations that provide traceable documentation at any time without process interruption. The ability to check the health status of an instrument eliminates issues or failures, reduces process downtime, and ensures optimal performance and planning cycles.

Speakers: Bethany Silva, Adam Battinieri, Adam Hughes; Endress+Hauser

Audrey has a strong track record of building life science startup companies through capital attraction, strategic relationships, novel technologies, and by assembling the finest management teams. Before launching CBM, Audrey spent two decades working in private equity and previously worked as an investment banker at Morgan Stanley and a public accountant at Deloitte. Ms. Greenberg is a dynamic speaker, champion of women’s leadership causes, and mentor to aspiring professionals. Audrey was recently selected by Philadelphia Magazine as one of the Top Trailblazers in Biotech and was featured on the cover of Main Line Today’s Power Women edition. Audrey has an MBA from the Wharton School at the University of Pennsylvania and is a registered CPA in Illinois.

Audrey is a member of the Board of Directors for New York Mortgage Trust (NASDAQ: NYMT), the Greater Philadelphia Chamber of Commerce, and the King of Prussia Business District. She is an active participant in the Chamber’s Diverse Procurement Collaborative, Philadelphia Skills Forward Initiative, and the CEO Council for Growth’s Cell and Gene Therapy and Connected Health Initiative.

Audrey is a fierce advocate for the global recognition of Greater Philadelphia as the number one location for Cell and Gene Therapy. She has spoken at over 50 conferences and panels over the last 12 months passionately promoting “Cellicon Valley” and speaking as a subject matter expert in building innovation hubs.

Description: Gap Assessments, Audits, CSV during the COVID-19 Pandemic

Learning Objectives:

• Regulatory Trends and 483/Warning Letter Landscape
• Global Trends in CSV (Computer Systems Validation)
• Present the Evolution of Gap Assessment, Audit, and Remediation during the Covid-19 Pandemic (with Case Study)

Speakers: Gaurav Walia, PQE Group

Description: The central task of the global pharmaceutical and biopharmaceutical industry is to contribute to human and animal health by providing the right medicines in perfect quality. However, the pharmaceutical industry has a responsibility that goes far beyond this – responsibility for the climate and the environment. The issue of climate protection could not be more topical and urgent: climate change is a real risk – for us as a global society, for every state, every business sector, and for every individual company.

A means of climate protection is decarbonization. This refers to the reduction of carbon, meaning the changeover to an economic system that sustainably reduces CO2 emissions. The long-term goal is to create a CO2-free global economy. In this context, the pharmaceutical industry is also able to make a contribution. This presentation will explore the measures that companies in our industry can take to pave the way towards CO2-neutrality.

The issue of climate protection could not be more topical and urgent: climate change is a real risk – for us as a global society, for every state, every business sector, and for every individual company. The Paris Agreement on Climate Change aims to limit global warming to a maximum of 2°C by the end of the century, or 1.5°C in the best case. Whether the current policy frameworks are ambitious enough to meet these targets is widely doubted. Sustained action is needed, and we must act now to counter the trend of high greenhouse gas emissions and increasing climate risks. Companies can play an important role here by investing in the reduction of greenhouse gases.

A suitable decarbonization approach reconciles the “bottom-up” perspective, which is based on technically realistic assessments, and the expectations from outside, i.e. a “top-down” view. All relevant areas and business activities are included in a holistic view. A science-based approach makes the strategy reliable for assessment.

Learning Objectives:

Speakers: Lindsay Smart, ZETA USA

Description: This educational session will discuss the timeline and integration challenges of designing and installing a highly potent compound isolator into an existing facility for Catalent in their Malvern, PA site. This isolator design provides flexibility for batches from 1kg to over 100kg and provides a containment performance target of 50 ng/m3.

• The use of isolators in the micronization of highly potent drug products
• Integration of a large commercial scale isolator into an existing facility
• Design of a multi-chamber isolator for both commercial and small-batch manufacturing

Speakers: Mac Dolton, SNC-Lavalin | Lee Schlossberg, Catalent | Eric Bohn, Jacobs Wyper Architects | Frederic Le Pape, FPS