Continued progress in the development of sensitive and high-resolution analytical technologies have enabled significant progress towards the goal of a Well Characterized Biological Product. These advances allow for detailed characterization of biotherapeutic modalities even as the structural complexity of these modalities increase. Additionally, rapid analytical methods with equivalent or better sensitivity and precision are replacing methodologies requiring longer lead-times, ensuring quicker patient access to lifesaving therapies. 

This session will focus on the current state of the art technologies utilized for product release and characterization, and how these technologies have evolved over time to accommodate product characterization of complex modalities with increased structural resolution.

FDA initiated “Pharmaceutical Quality for the 21st Century” about 20 years ago. Janet Woodcock, then the Center Director for CDER challenged the pharmaceutical industry to develop: “A maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high-quality drug products without extensive regulatory oversight.” In accordance with this “desired State”, ICH revised its quality vision emphasizing an integrated approach to quality risk management and science and embracing QbD to increase product and process understanding (ICH Q8 and Q11), application of risk management (ICH Q9), an effective pharmaceutical quality system (IH Q10), and most recently of pharmaceutical product lifecycle management (ICH Q12). In this QbD session, speakers from both industry and the FDA will provide a holistic overview of QbD and how QbD enhanced process and product understanding that alternately helped patients to access safe and effective, and high-quality biologics. A case study will be also presented followed by a panel discussion.

By attending this session your contact information will be shared with the exhibitor.

By attending this session your contact information will be shared with the exhibitor.

By attending this session your contact information will be shared with the exhibitor.

“Alone we can do so little, together we can do so much” is a Helen Keller quote which captures the spirit of CASSS-organized conferences like WCBP, the regional CMC strategy forums, and technology specific meetings. These venues offer platforms to exchange knowledge and align perspectives on manufacturing and controlling of biopharmaceuticals. Over the past 25 years, a variety of accomplishments have been achieved thanks to an attention to science and risk management. In this session CMC experts from regulatory agencies and industry will reflect in a familiar atmosphere on their personal highlights and learnings, including:

•    WCBP was born out of the separation sciences community. What applications of separation sciences do you judge to be most consequential to the understanding and regulation of biologicals today?

•    Strategies to assess comparability after manufacturing process changes and regulatory expectations were a recurring element at WCBP meetings. What have been the most positive outcomes from discussion in this area? With the benefit of hindsight: What should have been done differently?

•    The heroic efforts by industry and regulators to deliver successful vaccines and therapies for COVID would not have been possible without the groundwork of exchange and mutual understanding. What lessons have been learned from earlier discussions regarding breakthrough therapies? What further improvements might be made in the development and regulation of biologicals to facilitate efficient delivery of medicines and vaccines?

•    It feels like the former assumption ‘The process defines the product’ was reversed over the years with implementation of ‘quality by design’ elements into biologicals development and control. What have been the positive, and negative outcomes from the implementation of this approach? 




Session Facilitator:
IP Wassim Nashabeh, Genentech, a Member of the Roche Group

Session Participants:
IP Andrew Chang, Novo Nordisk Inc.
V Steven Kozlowski, CDER, FDA
IP Philip Krause, Retired; CBER, FDA
V Anthony Ridgway, Retired; Health Canada
V Ilona Reischl, AGES MEA
IP Nadine Ritter, Global Biotech Experts, LLC

V Ken Dychtwald, Age Wave

Ironically, history’s greatest accomplishment – increasing longevity– could become civilization’s biggest challenge. Left “uncorrected,” the ensuing age wave could cause: a misalignment of many aspects of society from pensions to playgrounds; a gerontocracy that could spark political age wars and pandemics of cruel and costly degenerative diseases such as Alzheimer’s. Due to the combination of longer lives, declining fertility, the aging of the massive global baby boom and the impact of COVID-19, every dimension of health and healthcare – as well as aging and longevity - are being both challenged and transformed. 

In this revealing glimpse into the future—Age Wave visionary Ken Dychtwald, PhD will explore: 

•    How long might we live?  

•    With further gero-scientific breakthroughs in longevity, at what age will old age begin?

•    Will our later years be a time of health and vitality or illness and disability? 

•    What advances are needed in diagnostics, medical/nursing skills, biotechnology, biopharmaceuticals, AI, preventative and rehab fitness and functional nutrition to ensure that our health spans match our lifespans? 

•    Will the boomers opt for "pro-aging," "anti-aging" or "ageless aging and how will they deal with "right-to-death" issues?

•    How will boomer women and men approach aging differently?

•    Will super-longevity be purchasable on the open or black market and how do we feel about “longevity inequality?” 

•    What will be the new purpose of elderhood?

Supply of raw materials has been a risk to the biomanufacturing industry for many years, however, the pandemic has worsened and accelerated what is now no longer a risk but a reality.

The session will explore how industry and the regulators are mitigating risks for the current and future state of the raw material supply chain; three perspectives will be shared, that of suppliers, end users and regulators.

Session Speakers:
10:45 - 11:10
Managing Raw Material Supply Chain Challenges during the COVID-19 Pandemic and Resulting Future Opportunities - A Roche Perspective
V Stefan Paschen, Roche Diagnostics GmbH

11:10 - 11:35
Supplying an mRNA COVID 19 Vaccine at Unprecedented Pace and Scale
V David Sullivan, Pfizer, Inc.

11:35 - 12:00
Regulatory Approaches to Manage Supply Chain Challenges
V Patricia Hughes, CDER, FDA

12:00 - 12:15
Discussion - Questions and Answers

In today’s world being able to supply medicines to patients faster is not only a competitive advantage but of critical importance for saving lives. In response to increasing demands for a broad range of modalities, Global Regulatory Agencies are using new and existing programs to reduce development timelines towards faster product licensure or authorization with the goal of patient benefit. Such increasing demands and the requirements of regulatory programs puts manufacturing on the critical path and has disrupted the way that products are developed. No longer do manufacturers have years to perfect the manufacturing process or build new facilities. Manufacturers are creating modular/mobile facilities and applying advanced analytical technologies to meet the demand. In addition, process development can be a key factor in speed to patient. The US FDA has used Emergency Use Authorization to enable faster distribution of drugs. This session will explore how these experiences can be used by the regulators and manufacturers to expedite development without impacting product quality. Talks will focus on available regulatory programs for accelerated product development, lessons from EUA applications that potentially can be applied to standard applications, manufacturing advances and a development perspective on how CMC can help enable speed to patients.