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Pharmaceutical and biotechnology companies employ platform analytical procedures in the development stages of their synthetic and biological drug products and are beginning to leverage them for commercial products. This shift is supported by the acceptance of platform procedures in the recently adopted ICH Q2(R2) and ICH Q14. Six case studies are shared in this article to highlight how...

Features

The pharmaceutical industry faces considerable challenges throughout the development, manufacturing, and supply of medicines, largely due to the intricate and divergent global regulatory landscape. The adoption of structured data standards and utilization of cloud-based platforms offer immense potential to overcome these challenges by facilitating faster and more efficient global...

Technical

The pharmaceutical landscape is rapidly evolving, and cell and gene therapies (C&GT) are at the forefront of this transformation. These therapies are revolutionizing how we approach patient care, particularly in the realm of personalized medicine. However, this innovation has also introduced challenges, especially when establishing new manufacturing facilities.

Technical

Computer software assurance (CSA) has been discussed widely in industry over the past five years. While the principles are well understood and welcomed, until now some of the practical detail on how exactly to implement CSA into an organization has been missing.

Technical

Drug delivery devices have become an essential component for many modern medical therapies, and it’s vital that they function as intended. However, the reality of marketed products shows that this is not always achieved because drug-device combination products are becoming increasingly complex, with an increasing number of potential failure modes. Significant challenges for engineers include...

Technical

Cell and gene therapy (C&GT) products address various diseases at the cellular or genetic level, offer innovative treatment approaches, and represent a significant advancement in the field of medicine. However, developers of C&GT products face unique challenges due to their complexity, such as establishing assays that show a clear link between potency, mechanism of action (MoA), and...

Technical

In 2011, the US Food and Drug Administration (FDA) introduced the revised “Guidance for Industry: Process Validation: General Principles and Practices.”  The document incorporated principles from...

InTouch

Anil Mathai first heard about ISPE 30 years ago. “I attended Drexel University, where you are required to complete three cooperative education jobs. One of mine was for Rhône-Poulenc Rorer, Inc. in Collegeville, Pennsylvania. While I was there, I learned about validation and decided that I wanted to be in pharmaceuticals as a chemical engineer.”

Online Exclusives

On 13 March 2024, ISPE concluded the 2024 Aseptic Conference with a regulatory panel question and answer session. Attendees were invited to submit questions to representatives from the Austrian Agency for Health and Food Safety (AGES), US Food and Drug Administration (FDA), Regierungspraesidium Tübingen (RP Tübingen), World Health Organization (WHO), Therapeutic Goods Administration (TGA), and...

Features

The pharmaceutical industry stands at the precipice of a revolution as emerging digital technologies provide new opportunities to boost productivity through continuous process improvements. The Pharma 4.0™ framework, an adaptation of the broader Industry 4.0 movement, aims to transform how drugs are produced and delivered.

Features

With the approval of the first gene edited therapeutic in 2023, production of gene edited therapies is accelerating, introducing tough decisions for manufacturing development. Gene editing therapy production is complex, often involving multi-modality manufacturing operations in one facility to produce a single therapeutic. This article considers whether retrofitting an aging monoclonal...

Features

Implementing advanced automation technologies is a strategic move that can amplify the positive outcomes of environmental, social, and governance (ESG) initiatives. By leveraging ESG initiatives, pharmaceutical companies can enhance their competitive edge and contribute positively to global sustainability efforts.

Features

Cell and gene therapy (C&GT) products represent a significant step forward in patient treatment and often offer unique patient benefits. However, product developers face significant hurdles within the regulatory landscape. The tools laid out in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q12 guideline: “Technical and...

Features

The US Food and Drug Administration (FDA) advocates for the integration of quality by design (QbD) principles throughout the pharmaceutical product development landscape, aiming to elevate both process understanding and product quality. Key challenges to the process control strategy include navigating time- and resource-intensive processes. One solution is digital shadow technology which, when...

Features

In the dynamic and highly regulated world of biopharmaceutical manufacturing, maintaining and ensuring quality is a critical success factor. An effective quality risk management (QRM) system is a key component in the overall quality management infrastructure of biopharmaceutical organizations. It offers a structured, scientific, and risk-based approach to decision-making, addressing potential...

Features

Advanced therapy medicinal products (ATMPs) and cell and gene therapies (C&GTs) represent a promising medical product class that employs gene therapy, cell therapy, or tissue engineering to address various diseases and injuries. One critical aspect of ATMP and C&GT manufacturing is using cell culture media. With thousands of ATMPs and C&GTs in clinical trial phases, the role of...

Features

Antibody engineering has transformed the development of therapeutic antibodies, enabling the creation of specific and effective treatments for a range of diseases. These antibody-based therapeutics are advancing in clinical development at a rapid rate and are being approved in record numbers. Currently, more than 100 monoclonal antibodies (mAbs) have been approved for the treatment of various...

Features

With the Chinese government initiating drug regulatory reform in 2015 and China joining the International Council for Harmonisation (ICH) in 2017, a significant number of measures have been implemented by the government. The aim is to make fundamental changes to China’s drug regulatory administration system so it can facilitate pharmaceutical development and better meet patient needs in the...

Features

Digital display labels (DDLs) offer an alternative solution to eliminate manual relabeling in the clinical supply chain, optimizing label content updates through a simple, system-controlled approach while providing new, uncharted opportunities. With increased efficiency in making regulatory-compliant changes and enhanced flexibility in the clinical supply chain, DDL technology has the...

Features

Due to the growing digitalization of the industry, we are highly dependent on information technology (IT) systems and data. The basic ability to execute our pharmaceutical business and decision-making processes relies on the permanent availability of these IT systems and data to ensure compliance and efficiency of our business operations. But numerous factors—including criminal activities,...

Features

IT infrastructure has traditionally been provisioned using a combination of scripts and manual processes. This manual approach was slow and introduced the risk of human error, resulting in inconsistency between environments or even leaving the infrastructure in an unqualified state. In this article, we investigate some fundamental advantages of using Infrastructure as Code (IaC) for...

Features

This article provides a brief introduction into the standards and regulations for medical devices. It compares the ISPE GAMP® 5 Guide: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) and applicable ISPE GAMP Good Practice Guides against the relevant regulations and standards for the development of software for medical devices and demonstrates GAMP® 5 Second...

Features

Advanced therapy medicinal products (ATMPs) are one of the most promising developments in the pharmaceutical and biotech industries in recent decades. Although there is a great promise to treat and even cure many diseases with these products, there are also unique challenges, especially with their supply chains.

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White Paper

Faced with global competition and shrinking margins, (bio)pharmaceutical manufacturers worldwide are urged to increase production efficiency by making better use of time and resources. This is in addition to addressing the unique challenges faced by pharmaceutical manufacturers such as a strictly regulated environment, heterogeneous equipment suppliers, and long adaptation times....

Latest Articles

iSpeak Blog

The 2025 Mentor ISPE program promises to be a transformative year filled with growth, collaboration, and valuable learning opportunities for both mentors and mentees. As ISPE mentors and mentees embark on this journey, they’ll have the chance to build meaningful professional relationships, gain fresh insights, and strengthen skills through guided support and shared experiences. Whether ISPE...

iSpeak Blog

The 2024 ISPE International Honor Awards were presented at the 2024 ISPE Annual Meeting & Expo in Orlando, Florida, in October. These awards provide the opportunity for the ISPE community to recognize and celebrate the dedicated professionals who volunteer countless hours to support ISPE and its mission. This award was presented to the family of Antonio Moreira, PhD, to posthumously...

iSpeak Blog

With over 23 years industrial hands-on experience in establishing and managing quality management systems within the pre-clinical, clinical and pharmaceutical as well as medical device manufacturing industries, Mei Ping Lee, who goes by Mae, is currently the Quality Assurance Manager at Winwa Medical Sendirian Berhad, Malaysia, a pharmaceutical and complementary products manufacturer and...

iSpeak Blog

The pharmaceutical industry is in the middle of a transformative shift, driven by the dual forces of Pharma 4.0™ and the updated Annex 1 guidelines. These changes are introducing innovations that not only enhance the quality and safety of sterile manufacturing but also leverage new technologies to optimize efficiency and compliance. The

iSpeak Blog

The pharmaceutical industry is on the verge of a profound transformation, driven by the digital advancements of Pharma 4.0™. This shift is set to redefine the design and construction of interconnected facilities, streamlining operations and optimizing production like never before. At this year's

iSpeak Blog

This blog post will discuss the relationship between large systems that manage records at the multi-batch, multi-site level of operation and the data integrity of those records. There are several aspects to consider and they are specific to this type of environment. <

Online Exclusives

This article summarizes the key findings from the 7th Pharma 4.0™ Survey, conducted in 2023. It explores the demographics of the survey respondents, maturity levels of Pharma 4.0™ adoption, enabling technologies being leveraged, anticipated benefits, and challenges encountered.

iSpeak Blog

Supply resiliency for pharmaceutical manufacturing has been a topic of increasing interest to global stakeholders (Figure 1), resulting in widespread attention and many perspectives on how to improve drug shortages and associated vulnerabilities in the drug supply chain. At its core, supply resiliency is the ability for a manufacturer to have the agility, capacity, quality maturity, and risk...

iSpeak Blog

In the rapidly evolving pharmaceutical landscape, artificial intelligence (AI) has been hailed as having the potential to revolutionize everything from drug discovery to pharmaceutical manufacturing. As the industry seeks to further explore and invest in potential opportunities for improvement and growth with AI, pursuing a thoughtful and informed approach to AI strategy planning becomes...

Online Exclusives

The regulation of drug shortage prevention has rapidly changed over the past several years due to large-scale, highly visible events, such as the COVID-19 pandemic, hurricanes, and geopolitical issues. Efforts to effectively address the complex and multifaceted issues contributing to drug shortages require close technical collaboration and clear communication between the pharmaceutical...

iSpeak Blog

Any validation or quality professional working in life sciences or other highly regulated industries must possess a thorough understanding of data integrity, its regulatory requirements, and the acronym commonly associated with it: ALCOA. Even those who consider themselves well-versed in the subject may be surprised to encounter an emerging concept: ALCOA++. This expanded framework (denoted by...

iSpeak Blog

ISPE Women in Pharma®’s dedication to diversity, equity, and Inclusion isn't just about aspirations: it’s about action. Mentor ISPE, launched in 2023 by members for members, is a testament to this commitment. Over the past two years, more than 700 professionals from around the world have joined ISPE on this journey, and as Mentor ISPE approaches its third year, the team invites ISPE...

iSpeak Blog

Miriam Kremer-van der Kamp is the Business Developer at VILS Switzerland GmbH and an active ISPE member with the ISPE Germany/Austria/Switzerland (DACH) Affiliate, ISPE Women in Pharma, and ISPE Emerging Leaders. In this interview, conducted by Edyna Miguez, Membership Growth Manager at ISPE, Kremer-van der Kamp weighs in on why she joined ISPE, the benefits she’s experienced thus far, and...

Current Issue

September / October 2024

PIC/S in Latin America: Harmonization of cGMP Procedures Cover: This article offers an overview of the benefits of Pharmaceutical Inspection Co-operation Scheme (PIC/S) membership for regulatory authorities and industry. It also highlights Latin American regulators’ current perspectives on PIC/S membership to increase awareness and encourage open dialogue about harmonization, recognition...