Viral Vector Platforms: Intersection of Facility and Program
Viral Vector Platforms: Intersection of Facility and Program
Features
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Realizing the promise of any novel viral vector therapeutic depends on the innovator’s ability to constantly meet evolving program requirements set in the product’s preclinical; clinical; chemistry, manufacturing, and controls (CMC); and market strategies. A key enabler to success is establishing a robust yet nimble viral vector manufacturing platform that delivers high-quality product on time and in full while managing costs.

Featured Articles

ATMP Facilities: Adapting to a Multimodal Future
Features
ATMP Facilities: Adapting to a Multimodal Future
In a recent advanced therapy medicinal products (ATMPs) innovator survey, two-thirds of respondents reported that they are developing multiple drug platforms.CRB Group. Cell and Gene Therapy Report. 2020. http://go.crbgroup.com/2020-horizons-atmp Without a guarantee of commercial success for any...
Reimagining CPV for a Pharma 4.0™ World
Features
Reimagining CPV for a Pharma 4.0™ World
The life cycle approach to process validation stresses the need for continued monitoring of process performance to ensure that the manufacturing process remains stable and predictable, i.e., in a state of control. This life cycle stage is known as continued process verification (CPV) or ongoing...
FOYA Winners Share Lessons Learned in Facilities Development
Features
FOYA Winners Share Lessons Learned in Facilities Development
What do recipients of ISPE’s prestigious Facilities of the Year Award (FOYA) know that has helped their projects succeed? What are the lessons learned from achievements in facilities development, including forward-looking projects that encompass and inspire changes in the industry? Pharmaceutical...
Pandemic Progress: Industry’s Journey From 2020 to Today
Special Reports
Special Report: Pandemic Progress: Industry’s Journey From 2020 to Today
In 2020, the world was grappling with how to slow the spread of the SARS-CoV-2 virus and appropriately treat people who had the COVID-19 infection without approved therapies or vaccines. In two years, there are multiple vaccines and treatments along with great knowledge about the virus—and about...
Special Report: Operation Warp Speed: A View From the Inside
Special Reports
Special Report: Operation Warp Speed: A View From the Inside
Operation Warp Speed coordinated US government support of the pharmaceutical industry’s effort to develop and deliver vaccines and therapeutics across the United States to fight the COVID-19 pandemic. This article provides an inside look at the work done by this team to address the threat posed by...
Joydeep Ganguly
InTouch
A Diverse Workforce Enables Businesses to Succeed
The lack of diversity in the pharmaceutical engineering industry is widely recognized. Less well understood is why change is so hard to achieve. From my years of work in this space, and through observation of ongoing efforts to embrace diversity in all forms, I have developed a hypothesis: Progress...
Moving From Cleanroom to Isolation Technology for ATMPs
Technical
Moving From Cleanroom to Isolation Technology for ATMPs
Advanced therapy medicinal products (ATMPs) pose specific manufacturing challenges beyond those typically addressed by pharmaceutical chemistry. Often in current ATMP applications, a change in approach is introduced at some point in the development process out of convenience or necessity, which...
Figure 1: General workfl ow for the application of model-assisted DoE (mDoE).
Technical
Mathematical Models in Experimental Design and Scale-up
The implementation of a mammalian cell-based biopharmaceutical manufacturing process demands robust methods for knowledge handling, from early-stage development and technology transfer to production scale. Mathematical process modeling can summarize this knowledge as the relationships of critical...
Figure 3: Example of spray coverage image and clean in place (CIP) execution image used as supporting evidence.
Technical
Accelerating Biopharmaceutical Virtual FATs in a Pandemic
Heightened awareness, due to the pandemic, of the need for domestic manufacturing capacity has rejuvenated the biopharmaceutical manufacturing industry and resulted in new commissioning projects. However, cross-country/continental travel restrictions and social distancing–based work protocols...
Figure 3: Industry develops a single global control strategy.
Features
Toward a Single Global Control Strategy: Industry Study
During the past decade, industry has experienced a proliferation of regulatory divergence regarding the interpretation and implementation of International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines (and control strategies) across...
Figure 3: Adoption time in years experienced by nonpharmaceutical and pharmaceutical industries since the technologies were invented/discovered.
Features
Measuring Pharma’s Adoption of Industry 4.0
With the rise of new technologies and predictive analytics capable of handling the huge amounts of data within and across existing information systems, Industry 4.0 has been thriving in many sectors, such as industrial automation, financial technology, retail, and semiconductors. But the health...
Figure 1: The 4 Ps of the pharmaceutical value chain are interconnected. Each element finds its virtual representation in a digital twin (figure © Zeta).
Features
Driving Biopharma Solutions with Digital Technologies
Developing comprehensive digital solutions is crucial for the entire value creation process for pharmaceuticals. A holistic view of the interrelations of product, production process, and plant is becoming increasingly significant. In this context, the application of model-based technologies...
Figure 1: Potency assay blind control Xbar-S chart.
Technical
Risk-Based Continued Test-Method Performance Verification System
Good data are a characteristic of good science. Quality data are arguably more important today than ever before and are considered by many to be a corporate asset because they are used to develop products and processes, control our manufacturing processes, and improve products and processes when...
Figure 3: AUC used as the metric evaluator for models 1 to 5 (2020 data) and model 1 (2018 data, bottom right).
Technical
Case Study: Water for Injection Plant AI-based Maintenance
This article presents the results of applying artificial intelligence (AI), such as machine learning algorithms, to identifying and predicting anomalies for corrective maintenance in a water for injection (WFI) processing plant. The aim is to avoid the yearly stoppage of the water for injection...
Carolina-South Atlantic (CaSA) Chapter
InTouch
ISPE CaSA: Attracting New Talent to the Pharmaceutical Industry
ISPE’s Carolina-South Atlantic (CaSA) Chapter serves members from six different states in the US: North and South Carolina, Tennessee, Alabama, Georgia, and Florida, each with their own unique contributions to the pharmaceutical industry.
Comparison between autologous therapies and allogeneic therapies
Features
Supporting Scalable Cell Therapy Using Allogeneic Workflows
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....
Changing Lives with Gene Therapies
Features
Changing Lives with Gene Therapies
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...
Figure 1: The data continuum touches every aspect of the patient experience.
Features
Personalized Medicine: The Industry’s Future
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...
Figure 2: Setting a risk-based CQV plan
Features
Today’s Pharma and Biotech Projects: A Phased Approach
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...
ISPE Global Pharmaceutical Regulatory Summit Speaker Panel
Features
Distant Assessments, Audits, & Regulatory Guidance
The ISPE Global Pharmaceutical Regulatory Summit, held virtually on 28 April 2021, brought together 11 regulators from different parts of the world to discuss how their approaches to GMP inspections have adapted to the COVID-19 pandemic.
Figure 1: PQLI integration over the product life cycle.
Features
PQLI®: Advancing Innovation & Regulation
A unique aspect of the pharmaceutical industry is the pairing of innovation and regulation. For nearly two decades, ISPE’s Product Quality Lifecycle Initiative (PQLI®) has worked at the nexus of pharmaceutical manufacturing technology and regulation to bring forward solutions that help advance new...

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Managing Frozen Transport Logistics in the Biopharmaceutical Cold Chain
White Paper — Sponsored Content
Managing Frozen Transport Logistics in the Biopharmaceutical Cold Chain
The enormous task of establishing a reliable infrastructure to supply COVID-19 vaccines across the globe has thrust cold chain shipping and its associated challenges into the spotlight. Valuable biologics, such as vaccines and recombinant therapeutic proteins, are often kept in a frozen state...

Latest Articles

2022 Volunteer Spotlight: FOYA Friday!
iSpeak Blog
2022 Volunteer Spotlight: FOYA Friday!
We would like to thank the judges of the 2022 Facility of the Year Awards (FOYA) program. The FOYA program has proven to be the premier global awards program focused on recognizing innovation and creativity in the design, construction, and operation of...
Read, Learn, Innovate: Quality Topics in Pharmaceutical Engineering®
iSpeak Blog
Read, Learn, Innovate: Quality Topics in Pharmaceutical Engineering®
Featured in this edition of the Pharmaceutical Engineering® Online Reading Roundup are recent technical articles about quality, including global commissioning, qualification, and validation; data for verification; and addressing N-nitrosodimethylamine (NDMA) impurities.
Enabling Digital Transformation in Biotech
iSpeak Blog
Enabling Digital Transformation in Biotech
Digital transformation has been growing in importance and urgency as the biopharma and biotech industry, manufacturers, and service providers seek to accelerate build-out of facilities and manufacturing processes in support of advanced biotherapeutics.
Article
iSpeak Blog
Synergy between ISMS & GxP Compliance for value add in Pharma IT
The Covid pandemic has pushed all companies to accelerate their digitization plans and ramp up adoption of emerging technologies. For regulated companies like Pharma, which operated in secure offices and fortified offshore development centers, this has also meant new ways of working and additional...
ISPE Guides
InTouch
ISPE Briefs: New ISPE Guides Explore ATMPs and Update Guidance on CTCs
Released in November 2021, the ISPE Guide: Advanced Therapy Medicinal Products (ATMPs)–Autologous Cell Therapy focuses on manufacturing facility development and design for autologous cell therapies for parenteral use. This guide provides an overview of the critical aspects of ATMP facility design...
Women in Pharma® Editorial: Jennifer Lauria Clark, CPIP
Insights
Women in Pharma® Editorial: Risks & Rewards
As a part of taking care of yourself, one must risk something. For me, taking a risk can be scary. I get nervous, anxious, and, at times, begin to doubt myself. Then I remember why I’m taking a risk and what the potential rewards will be, and confidently move forward with my decision.
Message From the Chair: Jörg Zimmermann
Insights
Message From the Chair: The Return to Live Conferences
The unprecedented speed in the development and global rollout of vaccines and treatments for COVID-19 over the last two years has made it possible to get back to a new normal. The 2022 ISPE Facilities of the Future Conference in February brought us together in person again and included a virtual...
Read, Learn, Innovate: Top Blog Posts from March 2022
iSpeak Blog
Read, Learn, Innovate: Top Blog Posts from March 2022
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from March 2022. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.
ATMPs/C&GT: Projects & Commercial Manufacturing
iSpeak Blog
ATMPs/C&GT: Projects & Commercial Manufacturing
The 2022 ISPE Biotechnology Conference on June 28-30 in Boston, MA and virtually will offer attendees several unique perspectives and case studies across several separate content areas.
How does your Company Dispose of Single-Use Plastics?
iSpeak Blog
How does your Company Dispose of Single-Use Plastics?
Single-use plastics are critical for healthcare, life sciences laboratories, and bioprocessing. They have many benefits over other materials and their use is increasing. In particular, single-use technologies for bioprocessing decrease costs, reduce water and energy usage, and increase efficiency...
Brunch with Biotech Connects Students with Industry Professionals
iSpeak Blog
Brunch with Biotech Connects Students with Industry Professionals
As Industry professionals devoted to developing and inspiring the love of STEM, it has always been our goal to share our knowledge and expertise with those who may be curious about the diverse roles available in the growing biotech industry, while also helping them to grow their professional...
Gaylord Palms - 2022 ISPE Annual Meeting & Expo location
iSpeak Blog
ISPE Annual Meeting 2022
As we emerge from a global pandemic that has impacted all aspects of life – both personal and professional, we, in the pharmaceutical industry, should take the opportunity to reflect, learn, and look forward to the exciting changes and innovations within our industry. The past two years have seen...
Read, Learn, Innovate: Pharmaceutical Engineering® on Drug Shortages
iSpeak Blog
Read, Learn, Innovate: Pharmaceutical Engineering® on Drug Shortages
Featured in this edition of the Pharmaceutical Engineering® Online Reading Roundup are articles addressing an issue that became a headline topic during the pandemic—and one that the industry continues to address: drug shortages and the supply chain. There are many questions about these issues:...
APQ Guide: Change Management (CM) System
iSpeak Blog
New ISPE APQ Guide Helps Companies Improve Change Management Systems
What is the current state of your organization’s Change Management (CM) System? The effective management of change throughout the product lifecycle enables quality improvement and is critical to patient safety, supply reliability, as well as operational effectiveness and efficiency.
ATMPs, mRNA, Digital Transformation, & More
iSpeak Blog
ATMPs, mRNA, Digital Transformation, & More
The 2022 Planning Committee is delighted to welcome attendance and registration for the fast-approaching ISPE Biotechnology Conference, taking place 28-30 June in Boston, Massachusetts and virtually.
Joyce M. Hansen
iSpeak Blog
Aseptic Conference Day 2: Keynote on Microbial Quality and Emerging Leaders
Microbial quality encompasses sterility assurance—and more, as discussed by Joyce Hansen, Vice President of J&J Microbiological Quality and Sterility Assurance at Johnson & Johnson in the keynote at the Plenary Session, “Microbiology Quality and Cultivating Emerging Leaders” that kicked off Day 2...
Read, Learn, Innovate: Top Blog Posts from February 2022
iSpeak Blog
Read, Learn, Innovate: Top Blog Posts from February 2022
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from February 2022. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.
Molecular Attributes
Sponsored Content
Molecular Attributes
Resins, Monoliths, or Membranes? Discover How to Make an Educated Choice.
ZETA
Sponsored Content
From Upstream to Downstream: Solutions for the Entire Process
As a pioneer in aseptic processing solutions, ZETA focuses on the design, construction, automation, and qualification of customized biopharmaceutical plants, using fully integrated digital engineering tools - all the way to the digital twin. Many years of experience and an outstanding ability to...

Current Issue

Pharmaceutical Engineering

May / June 2022

Viral Vector Platforms: Intersection of Facility And Program Cover: Realizing the promise of any novel viral vector therapeutic depends on the innovator’s ability to constantly meet evolving program requirements set in the product’s preclinical; clinical; chemistry, manufacturing, and controls; and market strategies. A key enabler to success is establishing a robust yet nimble viral vector...