SK pharmateco – Building a Sustainable Global CDMO Business for the next century
23 August 2023
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SK pharmteco was established in January 2020 to bring together SK biotek Korea,
Issue: July / August 2023
Life science leader debate: who will lead the way in data-driven life science innovation?
22 August 2023
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Leaders from BioNTech, Bayer, Iperion – a Deloitte business, and Beczek.COM came together in December 2022 to discuss the critical next steps for the life sciences industry in its transition toward a data-driven future. Max Kelleher, COO of Generis, chaired the proceedings.
EU Chemicals Strategy for Sustainability: implications for the regulation of endocrine disrupting chemicals
22 August 2023
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The 2020 EU Chemicals Strategy for Sustainability (CSS) has a strong focus on endocrine-disrupting (ED) chemicals, due to perceived concerns over their effects on human health and the environment. The CSS envisages strengthening both the CLP and REACH Regulations with respect to ED chemicals; the CLP Regulation has recently been amended to include additional classification categories for ED, and an ongoing review of REACH will introduce new ED-specific information requirements. These changes will be introduced alongside other measures, which together aim to prevent the development of ED chemicals and remove or restrict ED chemicals currently on the market.
Panel Discussion on SUSTAINABILITY
28 July 2023
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AN INTEGRATED APPROACH TO SUSTAINABILITY The panel discussion brings together a diverse and insightful
PFAS: the biggest restriction proposal ever
28 July 2023
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Following the procedure laid down by Annex XV of the REACH Regulation, on January
Building a lab of the future: how to drive business value at the bench
28 July 2023
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Artificial intelligence and machine learning are bringing digital transformation in labs to the next level, helping to fuel the emergence of “the lab of the future.”
Rather than focusing on data collection, the lab of the future enables data analysis, which in turn helps companies identify important lessons, insights, warnings, and opportunities coded inside scientific data. In the lab, this means greater efficiency and speed-to-market; in the boardroom, it means scientific data is available to support critical decision-making; on a global scale, it positions labs to help address humankind’s most complex and dynamic problems.
Process characterization of viral vectors: approach in CDMO context
28 July 2023
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When preparing the clinical supply for product development, viral vectors manufacturers and CDMOs (Contract Development Manufacturing Organisations) have to balance complex requirements. They are expected to move very fast in a highly complex environment, while generating a comprehensive and extensive set of data to submit to Heath Authorities for review. Within the regulations, more and more emphasis is put on Quality by Design (QbD) and process characterization, but the time allocated to these is decreasing. Here, we are discussing two case studies that provide examples on how CDMOs can apply process characterization principles to deliver clinical supply and a robust data set, in due time and of the highest quality.
Addressing barriers in implementing pharmaceutical continuous manufacturing – Key concepts & challenges in pharmaceutical continuous manufacturing
28 July 2023
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Pharmaceutical continuous manufacturing (PCM) can reduce production time, decrease labor costs, and optimize process flow and the supply chain. Although some industry leaders have already invested in PCM, its widespread implementation has yet to be achieved. Major challenges to adoption include knowledge gaps in multiple aspects of quality control, workforce capacity limitations with a lack of PCM expertise, logistics, uncertainty around regulations, start-up costs, industry economic dynamics including significant excess batch manufacturing capacity for generic medicines, and low prices for generics that can impede capital investment in PCM. To address these issues, it is necessary to ramp up education on the broader concepts, equip the workforce with the necessary skills, partner with organizations with adequate resources to ascertain quality control, alleviate uncertainty around regulatory review, and facilitate exploration of where PCM may be most impactful in terms of return on investment.
Elacestrant
28 July 2023
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Elacestrant (RAD1901), sold under the brand name Orserdu, is an anticancer medication which is used in the
A look at PAT technological developments PAT advances lead to greater knowledge for continuous manufacturing
28 July 2023
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As we look back at 2004 when the U.S. Food and Drug Administration (FDA) first released its Guidance for Industry PAT – Framework for Innovative Pharmaceutical Development and Quality Assurance, it is clear to see how much Process Analytical Technology (PAT) and its applications have progressed over the last 19 years.
In particular, there are four elements that this article considers: sampling, chemistry, sensors, and software programs. The latter are an integral part of the other elements and include specialized software platforms that have been developed to optimize PAT applications.
The article explores the development of these core aspects to support Quality by Design (QbD), PAT, and continuous manufacturing as well as their impact on pharmaceutical manufacturing.