Globally, there is an increase in approved advanced therapy medicinal products (ATMPs), with thousands of therapies currently in various stages of pre-clinical and clinical development.
Globally, there is an increase in approved advanced therapy medicinal products (ATMPs), with thousands of therapies currently in various stages of pre-clinical and clinical development.
The pharmaceutical industry stands at the cusp of a transformative era, where the integration of sustainability within the supply chain is not just a trend, but a necessity. The 2024 ISPE Annual Meeting &...
Although parenteral products make up only 1% of global pharmaceutical prescriptions by volume, at list price they now make up nearly half of global sales value, a percentage that has been increasing. Many of these are complex products produced in smaller batches for immunology or oncology, and a large majority are biologic therapies, which are generally poorly suited to oral formulations.
In 2020, CSL initiated a benchmarking activity with a small group of peer companies identified through ISPE to explore creation and maturation of asset management programs at each company. The initial sessions were a success, covering topics such as asset condition evaluations and asset management governance. CSL was keen to continue the conversations and gather more insights on certain...
Pfizer Asia Pacific Manufacturing Ltd has been honored with the 2024 ISPE Facility of the Year Award (FOYA) Category Award Operations in Project Execution. This prestigious award recognizes the outstanding efforts behind the Pfizer API Facility Extension, commonly referred to as Tuas 2, located in Tuas, Singapore.
As with all aspects of our life sciences industry, understanding how we can best meet the needs of patients with the timely delivery of life saving and sustaining products is of paramount concern. During the years since the global pandemic, the expectations and pressures on the pharmaceutical industry with respect to development, speed to market, quality and sustainability have increased...
At the 2024 ISPE Europe Annual Conference, held in Lisbon, Portugal, 16-18 April, Richard L. Friedman, MS, Deputy Director of the US Food and Drug Administration’s (US FDA) Office of Manufacturing Quality, in...
Insight from Austria’s Regulatory Authority Representative
At the 2024 ISPE Aseptic Conference, held March 12-13 in Vienna, Austria, Christina Meissner, a European Union Good Manufacturing Practice (GMP) inspector at the Austrian Agency for Health and Food Safety since 2013, and Chair of the PIC/S Drafting Group on Annex 2A and 2B, published in May 2021, offered a presentation titled...
The ISPE community is saddened by the passing of James (Jim) O'Brien, a founding member of ISPE and a luminary in the field of pharmaceutical engineering. Jim was a recognized expert in the design and engineering of pharmaceutical facilities, whose profound influence has shaped our industry.
Having a universal and uniform Common Technical Document (CTD) for all markets, major and emerging, is an aspiration of all pharmaceutical companies. As markets become more familiar with the CTD, especially the quality portion, some drug regulatory agencies are requesting more regional/local documents and customization to CTD documents in accordance with their local interpretation and...
During the COVID-19 pandemic, vaccines were one of the drug products recommended by the World Health Organization (WHO) to fight the pandemic. The majority of regulators have flexed their local regulatory requirements to bring vaccines to the market with as much supply flexibility as possible, including emerging markets which typically have challenging local requirements that a marketing...
This blog summarizes a presentation by Rick Friedman, Deputy Director of the US FDA Office of Manufacturing Quality, on 17 April 2024 at the 2024 ISPE Europe Annual Conference in Lisbon, Portugal. The...
One of the keynote sessions of the 2024 ISPE Europe Annual Conference held 16-18 April in Lisbon, Portugal was a presentation on EU initiatives to advance digitalization in manufacturing by Evdokia...
ISPE connected with Sydney Hamilton, Strategic Facility Planner, CRB, and Scott McNallan, Director of Architectural Design, CRB, for a sneak peek look at their planned session, “Blank Slate to Building Excellence,” ahead of the 2024 ISPE Biotechnology Conference. The conference will take place 17-18 June 2024 in Boston, Massachusetts, USA.
It becomes clear that a topic has become mainstream when it crosses multiple Communities of Practice and areas of interest. In preparation for the 2024 ISPE Annual Meeting & Expo, the Digital Transformation track committee worked closely with multiple teams from other tracks on the topic of artificial intelligence/machine learning (AI/ML) to identify the best...
Green chemistry is a field of chemistry that focuses on developing and utilizing more sustainable and environmentally friendly chemical processes and products. Green chemistry is a growing field in pharmaceutical laboratories that aims to reduce the environmental impact of drug discovery, development, and manufacturing processes. It involves the application of sustainable and innovative...
Time has a remarkable ability to slip through our fingers, doesn't it? With June's arrival, we're reminded of how swiftly the year passes. As we transition into the third quarter, it's a pivotal moment for us to reassess our goals and lay the groundwork for the months ahead, even looking ahead to the following year. View the full blog for recent membership announcements, etc.
We've had the opportunity to interview Hilal Yamaner, an active ISPE Emerging Leader and member of ISPE Women in Pharma®. Throughout this member spotlight, she shares her journey with ISPE, her perspective and passion for AI integration, the work she’s put in to planning a related ISPE Women in Pharma panel session at the upcoming
A recently released guidance document, the ISPE Guide: 503A Compounding – Regulatory Basis and Industry Good Practices for Pharmacies, summarizes and contextualizes key information from US governmental bodies relevant to...
On 17 April 2024 at the 2024 ISPE Europe Annual Conference in Lisbon, Portugal, a panel discussion titled “Harmonization to Break Down Barriers to Robust Supply Chains” featured an international panel of experts who discussed drug recalls, drug shortages, risks that can lead to poor drug product quality, quality risk management, Annex 1 implementation and its effect on the supply chain,...
Eli Lilly has recently achieved a remarkable milestone with the completion of its new synthetic peptide manufacturing facility/platform at its facility in Kinsale, Ireland. This cutting-edge project not only enhances production capabilities but also exemplifies a commitment to innovation and safety. Below is an overview which delves into the details of this groundbreaking achievement and...