Josh Ludwig, Global Commercial Director, ScaleReady Over the past decade, the landscape of cell and gene therapy (CGT) has experienced transformative growth. Artificial intelligence (AI) and automation will be necessary next steps for CGT manufacturing to reach its full potential. However, in order for these new technologies to play that role, it’s crucial first to understand them in the context of the particulars of these therapies. At its core, cell therapy involves administering live cells to a patient to treat or prevent a disease. This can be as straightforward as replacing damaged cells with healthy ones. Gene therapy, conversely, involves…

In the dynamic landscape of pharmaceutical manufacturing, striving for sustainable practices has transitioned from a choice to an imperative. The pharma industry significantly contributes to greenhouse gas emissions, primarily due to energy-intensive manufacturing processes and global supply chains. With universal sustainability goals influencing the decision-making of several industries, pharmaceutical companies are navigating complex challenges to align their operations with environmentally responsible practices and regulations. This path towards sustainability, however, is strewn with many obstacles. In this article, Dr Julian Northen, Solid State Manager at Onyx Scientific, explores the challenges associated with achieving sustainability in pharma and the solutions the industry…

Signal detection in post-market drug monitoring has changed little in 70 years, but now that shake-up is coming in the form of advanced AI technology combined with democratised access to standardised real-world data. The result will be a rapid and widespread adoption of proactive signal detection. And not just in adverse event monitoring, but also in identifying previously untapped opportunities for drug repurposing, says ArisGlobal’s Elizabeth Smalley. There has been little advancement in the discipline of safety signal detection and analysis since the early 1960s, when the practice was first introduced in response to the high-profile thalidomide tragedy. Systematic monitoring…

Pfizer have announced the successful completion of its acquisition of Seagen Inc, a global biotechnology company that discovers, develops and commercialises transformative cancer medicines. Pfizer completed its acquisition of all outstanding common stock of Seagen for $229 in cash per share, for a total enterprise value of approximately $43 billion. “Cancer remains a leading cause of death, and one in three people in the U.S. will receive a cancer diagnosis in their lifetime. With one of the largest investments in Pfizer’s history, we are going all in on cancer with the goal of delivering breakthroughs that drastically improve the lives of…

Typically, Q&A’s are focused on a single topic or a single individual. To keep things interesting, here at EPM HQ, we devised a range of questions to put towards a varied group of subject matter experts at Lonza. Here’s what they had to say… Jai: Lonza state that they’re focused on “supporting clinical trials from pre-clinical through to Phase III and launch”. What are the key challenges to overcome when building the pathway from pre-clinical trials to product launch? ​​Jakob Bonde, Head of Regulatory Affairs, Small Molecules: The key challenge is obtaining sufficient manufacturing process knowledge to deliver the phase-appropriate…

SGD Pharma has been a leader in the moulded glass packaging market for a significant number of years. Central to their vision and plan is a persistent striving for excellence that runs through the company from top to bottom. To better understand the company and their plans for the future, we at EPM HQ sat down with Olivier Rousseau, CEO of SGD Pharma, for a quick discussion… Jai: Can you outline the strategy for SGD Pharma? Olivier: Our vision is to become the global market leader in primary pharmaceutical glass packaging, not just for moulded glass which we currently are.…

The annual Pharmapack Drug Delivery Innovation Index is released ahead of Europe’s premier drug delivery and packaging event, Pharmapack Europe 2024. The results showed a slight increase on the record scores seen in the 2023 survey, indicative of a continued resurgence in confidence and innovation across pharma R&D. The Index [scored out of ten] is a collateralised metric of drug delivery and device innovation across the major pharma nations. Significantly for industry prospects in 2024, the index rose very slightly to 7.45 up from a previous record score 7.44 in 2023. With the majority of countries maintaining or seeing slight falls in year-on-year…

Alkermes plc have announced that it has entered into a definitive agreement to sell its development and manufacturing facility in Athlone, Ireland to Novo Nordisk, a leading global healthcare company. Under the terms of the agreement, upon the closing of the transaction, Alkermes will be entitled to a one-time cash payment of $92.5 million for the facility and related assets, subject to customary adjustments in accordance with the agreement. The transaction is expected to close in mid-2024, subject to certain closing conditions. “As we prepare to enter 2024 as a pure-play neuroscience company, we have continued our focus on aligning our infrastructure and cost structure with the…

ACG, the world’s largest integrated supplier and service provider to pharmaceutical industry celebrated the inclusion of its capsule manufacturing facility in Pithampur, India, into the esteemed Global Lighthouse Network (GLN) by the World Economic Forum. WEF’s Global Lighthouse Network is a community of manufacturers which shows leadership in using Fourth Industrial Revolution technologies to transform factories, value chains and business models, for compelling financial and operational returns. Remarkably, the GLN has experienced exponential growth since its inception, expanding from 16 to 153 lighthouses. This initiative is a collaboration between WEF and Mckinsey & Company with independent panel of experts designating…

Owkin, a French-American biotechnology company that applies artificial intelligence (AI) to drug discovery, development, and diagnostics, have announced that it has entered into a collaboration agreement with MSD, the trade name of Merck & Co Inc., Rahway NJ USA to develop and commercialise AI-powered digital pathology diagnostics for the EU market. Clinical trials have shown that the MSI-H tumour phenotype has potential prognostic and therapeutic importance, especially with the increased application of immune checkpoint inhibitor (ICI) therapies. As such, MSI-H has become an important genomic biomarker with applications across several types of cancer. As a result, testing for MSI-H is now…

The Novo Nordisk Foundation is committing up to DKK 1.8 billion (USD 260 million) to establish a research and vaccine development initiative. The aim is to create new or improved vaccines for some of the deadliest respiratory diseases, including tuberculosis (TB) and influenza. Developed in partnership with the University of Copenhagen, it is the first vaccines initiative globally to focus solely on understanding how to generate immunity in the airway itself. This is a potentially revolutionary means to block infection and prevent airborne diseases spreading between humans. A key partner in the initiative will be Denmark’s Statens Serum Institut (SSI). …

James Sheppard, Managing Director (UK&I) at Kadans. Since the pandemic, the life sciences industry has experienced highs and lows. From a boom in demand to waning investment, organisations have had to constantly adapt to macro-pressures. With squeezed budgets thanks to the cost-of-living crisis and the way that we all work changing for good, life sciences companies need to rethink their priorities — or risk the future of their organisation. With the rise in digital health, continuous development of preventative and personalised treatments, and the challenges of ageing populations, the life sciences real estate sector continues to evolve. Demand for specialised…

The R21/Matrix-M malaria vaccine developed by the University of Oxford and the Serum Institute of India, leveraging Novavax’s adjuvant technology, has been awarded prequalification status by the World Health Organization (WHO). This milestone represents a key step in making the vaccine accessible to those who need it the most. It follows the conclusion of a rigorous regulatory process and clinical assessment, supporting the vaccine’s efficacy and safety. The prequalification moment comes shortly after the vaccine has been recommended for use by the WHO’s independent advisory body, the Strategic Advisory Group of Experts (SAGE) and the Malaria Policy Advisory Group (MPAG) in October…