Bioprocessing and biomanufacturing – Page 3
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ArticleHarnessing industry advancements to accelerate upstream process development
Here, Shidong Shi, Head of Upstream Process Development, and Li Yang, Vice President of CMC Development at Altruist Biologics, discuss the key trends in upstream processing and highlight their approach for overcoming challenges in the field.
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ArticleBiosimilar medicines: the intersection of access, affordability, and innovation
In this article, Julie Maréchal-Jamil, Director, Biosimilar Policy & Science, Medicines for Europe, explores the strategies needed at European and national levels to secure the benefits of biosimilar medicines in an evolving landscape to deliver a pipeline for these drugs by 2030.
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ArticleConsiderations for a successful tech transfer of a biologics upstream process
Bioprocess experts from Lonza discuss how molecular format and the product lifecycle phase impact the process, risks and outcomes of upstream technology transfer of biologics.
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ArticleM&A outlook for pharma in 2025
For a strong 2025, dealmaking should be central to the life sciences strategy, says EY’s annual M&A report.
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ArticlePotential blockbuster drugs to watch in 2025
Eleven drugs are poised to make waves in the pharmaceutical industry in 2025, according to the annual report.
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ArticleHydrogel encapsulation: unlocking the potential of cell therapies for targeted treatments
In this article, Dr Stephen Harrington, Director of Cell and Hydrogel Formulation and Francis Karanu, Vice President of Cell Therapy R&D, Likarda, discuss the benefits of hydrogel encapsulation in drug delivery and enhancing the bioavailability and functionality of cell therapies.
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Article
The year ahead for RNA therapeutic development and manufacturing
As the industry prepares for a new year, Dr Kate Broderick, PhD, Chief Innovation Officer of Maravai Life Sciences and TriLink Biotechnologies, shares her thoughts on what the RNA therapeutics landscape of 2024 can tell us about what may be on the horizon in 2025.
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ArticleHow automation and digital technologies will unlock the full potential of advanced therapies
Automation and digital technologies, combined with workforce training and regulatory advancements, hold the key to transforming the production of advanced therapies. Dr Stephen Ward, Executive Director at CGT Catapult, shares how leveraging these innovations can facilitate the delivery of life-changing therapies to patients at scale, opening new possibilities for treating ...
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ArticleICH Q6(R1): test criteria and specifications
Dave Elder shares industry thoughts on an ICH Q6(R1) concept paper that aims to revise general principles for uniformity and consistency across ICH Q6 guidelines for test criteria and specifications.
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ArticleTargeting ovarian cancer with a novel antibody therapeutic
Christina Pelizon, International Medical Affairs Head for Oncology at AbbVie discusses the significance and impact of the European Commission’s approval last month of Elahere® (mirvetuximab soravtansine) to treat ovarian cancer.
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ArticleInvesting in the future of pharmaceutical microbiology QC
Troy Wright, Senior Vice President and Global Head of Quality at Abzena, shares an overview of current major challenges within pharmaceutical microbiology quality control, including the lack of staff knowledge in advanced technologies and how the sector’s importance can be overlooked, despite its key role in bringing safe, quality products ...
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ReportPharma Horizons: Sustainability
European Pharmaceutical Review’s latest Pharma Horizons report provides insight on key sustainability developments in the pharmaceutical industry and covers topics including regulation, manufacturing and clinical development.
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ArticleThe EU AI Act: will regulation drive life science innovation away from Europe?
Mike King, Senior Director, Product & Strategy (Quality, Regulatory, Safety & Detect), Digital Products & Solutions at IQVIA and Alex Denoon, Partner at Bristows Law Firm, explore the challenges of implementing the EU AI Act and the impact of GDPR requirements in life sciences.
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ArticleEnvironmental Monitoring In-Depth Focus 2024
This in-depth focus features articles on environmental monitoring trends such as digitalised management of EM data, as well as endotoxin detection.
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ArticleEuropean Pharmaceutical Review Issue 5 2024
European Pharmaceutical Review Issue 5 includes articles on bioprocessing, biologics, sustainability, and drug formulation.
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ArticleLife sciences response to 2024 Autumn Budget
Research and innovation is highlighted in the UK’s Autumn Budget as a priority ‘crucial national asset’ to aid long-term economic growth.
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ArticleDeveloping donanemab - balancing cost versus benefit
This article summarises recent regulatory developments surrounding the Alzheimer’s treatment donanemab and considers the future therapeutic market for this disease.
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ArticleInnovating allergy drug delivery with a needle-free alternative
Dr Sarina Tanimoto, MBA, Co-Founder and Chief Medical Officer of ARS Pharmaceuticals, discusses the company’s EURneffy adrenaline nasal spray as a novel, needle-free option to older approved injectables such as intramuscular injection, following its authorisation in the EU and US.
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ArticleAdvancing environmental monitoring systems for CGT manufacturing
Gill Lewis, QP and Chief GMP Consultant, eXmoor Pharma. discusses the company's approach to environmental monitoring and the key challenges faced during integration at its Cell and Gene Therapy Centre in Bristol, a facility which received a GMP license from the MHRA in August.
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ArticleCPHI Milan 2024: everything you need to know
CPHI Milan takes place in October, covering a wide range of topics from packaging and drug delivery to integrated pharma.