Nicola Carandente, Sales Group Director, Bormioli Pharma
2 October 2024
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Which environmentally friendly solutions do you offer with EcoPositive and what are the main
Issue: September / October 2024
Saurabh Gurnurkar, Managing Director & CEO, Uquifa Group
2 October 2024
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Q: Can you provide an overview of UQUIFA Group evolution as a leader in
Personalised medicine – utopian future or a new healthcare norm?
1 October 2024
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Universalised healthcare may soon be outdated as advancements in genomics, bioinformatics, and related fields are changing the face of medicine. Moving from a one-size-fits-all approach to personalised care offers major benefits, like better treatment effectiveness and cost savings by tailoring interventions to individual genetic profiles. Although there are challenges, such as needing specialised infrastructure, funding, and navigating regulations, personalised medicine has the potential to improve preventive care, optimise treatments, and create a more efficient healthcare system.
Collaboration key to delivering targeted medicines
1 October 2024
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Targeted medicines continue to make headway in the battle against chronic disease, changing the prognosis for many cancer patients, with the promise of breakthroughs in other fields. But the path to development and regulatory approval for these transformational products is complex, requiring a high degree of collaboration from the outset. This is particularly critical considering the urgent need of patients awaiting innovative treatments.
There are clear benefits in therapeutic and diagnostic teams working closely together during the development of targeted therapies. Similarly, sponsors that make the most of opportunities to engage with regulators as early as possible are better positioned to navigate the path to approval.
Risk Assessment for Different Formulations in a Highly Potent Drug Facility: Oral Solid Dose & Liquid Dosage Formulations
1 October 2024
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Handling of highly potent active pharmaceutical ingredients (HPAPIs) within a shared multi-product GMP facility requires proactive risk assessment for both quality and occupational reasons: preventing cross-contamination means safer medicines for patients, while preventing unacceptable exposure means a safer environment for workers. Thorough risk assessment requires careful consideration of numerous factors including health-based exposure limits, the formulation and associated physical properties, the manufacturing process, batch size, and the available facility and product handling engineering controls. Personal protective equipment must always be a last resort. In this article, some important considerations are presented when assessing risks for different formulations in a highly potent drug facility for oral solid dose and liquid dosage formulations, including contrasting cross-contamination risk assessment vs occupational risk assessment.
Unlocking Trends in Highly Potent APIs: From Toxicology to Eco-Friendly Manufacturing, Development and More
1 October 2024
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In this article, we explore the current trends in high-potency active pharmaceutical ingredients, focusing on the impact of the human factor, outsourcing, and technological advancements. We also address critical issues of manufacturing such as containment and handling, cleaning and cross-contamination, and the ongoing challenges related to occupational health and environmental protection. Our goal is to provide insights that help navigate the complexities of HPAPI production and best practices in the industry.
Angelini – Pharma 4.0: Race to digitalization
1 October 2024
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Digitalization in the pharmaceutical industry refers to the integration and adoption of digital technologies
Bridging AI and GMP Standards in the Future of Pharma
1 October 2024
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This article examines the integration of Artificial Intelligence (AI) in pharmaceutical manufacturing, particularly in regard to Good Manufacturing Practice (GMP) standards. While AI offers significant potential, challenges remain in regulation and validation. Regulatory bodies like the FDA and European authorities are working on incorporating AI into GxP processes, but specific guidelines are still in development. The report highlights recent advancements, including a proposed validation framework and examples of successful AI applications in GxP-compliant production. Overall, AI adoption in pharmaceutical manufacturing is advancing, but it should be approached cautiously to maintain product quality and patient safety.
Farmhispania Group launches flow chemistry platform for research, development and manufacturing of new generation APIs
1 October 2024
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INTRODUCTION Today, flow chemistry is playing an increasingly important role in modern process chemistry.
Towards Individualized Medicine: Embracing Digital Twins and Digital Dependability in Pharma 4.0
1 October 2024
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The pharmaceutical manufacturing industry is undergoing a transformative shift towards decentralization and modularization, significantly enhanced by the implementation of digital twins, automated manufacturing, and digital reliability. These technologies improve flexibility, efficiency, and quality assurance by creating virtual replicas of devices, processes, and patients, enabling personalized medicine and optimized drug formulation. Standardization initiatives like Asset Administration Shell (AAS) and Fast Healthcare Interoperability Resources (FHIR) ensure seamless integration and interoperability across systems. Digital dependability frameworks, such as the Digital Dependability Identity (DDI), enhance safety and risk management through predictive analytics. This integration of advanced digital technologies promises to revolutionize pharmaceutical manufacturing, fostering innovation and improved patient outcomes. The aim of this article is to highlight the current advancements and significant potential of digital twins in personalized medicine, and to encourage exploration of new challenges in this field.