November / December 2021

November / December 2021

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AI’s Promise for ATMPS

Cover: Industry 4.0 applications in biopharma involve the complete spectrum of data science throughout the entire product life cycle of many disparate entity types. Tools such as digitalization, modern data science, and the industrial internet of things are becoming requirements for modern implementations including advanced therapy medicinal products (ATMPs). This article addresses artificial intelligence and how it can help deliver on the promise of Industry 4.0 approaches to the entire product life cycle, from biology and medicine through product research and development, to validation, manufacturing, and post-launch surveillance.

Supporting Scalable Cell Therapy Using Allogeneic Workflows

Feature: Historically, cell therapies are used to treat patients with cancer after relapse from other approved treatment modalities, or if no approved treatment is available. However, the introduction of allogeneic cell therapies has created exciting opportunities to broaden access to cell-based treatments. With advancements in manufacturing, developers are becoming increasingly interested in commercializing allogenic therapies, bringing them one step closer to becoming broadly available to more patients.

Personalized Medicine: The Industry’s Future

Feature: With so many options for personalizing our lives, is the personalization of medicine far behind? With all the data available, how can the industry bring personalized medicine to patients? This article explores what is currently available and where the pharmaceutical industry can move forward to better serve patient needs.

Continuous Process: Implementing Low pH Viral Inactivation in a Continuous Process

TECHNICAL: Viral inactivation (VI) is a critical step in ensuring the safety of monoclonal antibody (mAb), Fc fusion, and recombinant protein therapeutics and it is typically an important component of an overall virus control strategy for downstream biotherapeutic production processes. Considerations for successful implementation of an inline VI process are discussed in this article.

Software as a Service: The Journey to Becoming a Life Sciences SAAS Provider

TECHNICAL: Use of software as a service (SaaS) applications within the life sciences industry is growing. This article reviews the issues and challenges faced by SaaS providers and identifi es the qualities of successful providers for this highly regulated industry.

In This Issue

Features
Industry 4.0 applications in biopharma involve the complete spectrum of data science throughout the entire product life cycle of many disparate entity types. Tools such as digitalization, modern data science, and the industrial internet of things (IIoT) exist now, and examples from other industries...
Insights
The 2021 ISPE Annual Meeting & Expo brings my year as ISPE International Chair of Emerging Leaders (EL) and Emerging Leaders representative on the ISPE International Board of Directors to an end. I would like to say thank you to all the Emerging Leaders members and volunteers for the hard work...
Features
Historically, cell therapies are used to treat patients with cancer after relapse from other approved treatment modalities, or if no approved treatment is available. However, the introduction of allogeneic cell therapies has created exciting opportunities to broaden access to cell-based treatments....
Features
With so many options for personalizing our lives, is the personalization of medicine far behind? With all the data available, how can the industry bring personalized medicine to patients? This article explores what is currently available and where the pharmaceutical industry can move forward to...
Features
The process of bringing new drugs and products to market requires creativity, thinking outside the box, and the courage to fail numerous times before making a single discovery. This rings especially true now, as the industry faces the COVID-19 pandemic and doubts about vaccines and therapies...
Features
This article revisits the concept of phased engineering, procurement, and construction (EPC) and updates it with risk-based considerations specifically regarding the commissioning, qualification, and validation (CQV) of general life-cycle principles for pharma and biotech projects. Enhancing the...
Insights
“The only constant in life is change.” This quote is as true today as it was 2,500 years ago when Heraclitus laid out his philosophy. In the last five years, the word “cure” has been used to describe new therapies targeting many different cancer and hereditary diseases. The potential of these...
Insights
Pharmaceutical Engineering® has announced the finalists and winners of the Roger F. Sherwood Article of the Year for 2019 and 2020. The 2019 award finalists and winner were not announced last year due to the pandemic. Winners of both awards are being recognized at the 2021 ISPE Annual Meeting &...