Biosimilar Development

How 'Explainable ML' Can Improve Process Performance https://lnkd.in/e986hgjS - By Lukas Gerstweiler and Zhen Zhang, University of Adelaide? The bioprocessing sector has been slower to adopt AI for process development, control, and analysis.?

The Araris team is excited to share that our co-founder and CSO Dr. Philipp Spycher will join the Bioprocess Online Virtual Panel on March 25 to discuss our latest advancements in ADCs. ? This panel will be an excellent opportunity to dive deep into the future of ADC technology and accelerating ADC process development. Register for the event and learn more about our approach to developing multi-payload ADCs: https://lnkd.in/eqY38xzy #Araris #BioProcessOnline #ADCs?

Do Patient Needs Define Biologic Product Specifications?? https://lnkd.in/eXbPw5nD - By Gerald Gellermann, André Mischo, Rainer K?ck, and Stephan Kirsch, Novartis Technical Research and Development Figure 1: Different ways to ensure pharmaceutical quality

A Practical Guide To Defining Priority Data In MES https://lnkd.in/ekG5Pgi3 With the rise of Industry 4.0, manufacturers increasingly rely on data to drive decisions and improve processes. Manufacturing execution systems (MES) play a crucial role in the digitalization of manufacturing operations.

Trends In FDA FY 2024 Inspection-Based Warning Letters https://lnkd.in/e2_x5YET - By Elizabeth Oestreich, Kalah Auchincloss, and Erin Hartmann, ELIQUENT Life Sciences As anticipated, the majority of inspection-based warning letters were issued to domestic firms in FY24. However, we saw a stark contrast in the difference between domestic and international inspections in FY24 and a rise in not only the number but also the diversity in the origin of the letters.

Managing Contamination Risks In The Pharmaceutical And Medical Device Industries Using Relational Risk Analysis https://lnkd.in/eNw8pcpJ - By Mark F. Witcher, Ph.D., biopharma operations subject matter expert A description of how relational risk analysis (ReRA) models can be used to understand and analyze contamination risks for efficiently building risk-based contamination control strategies (CCSs).

Adapting to Evolving Regulations: Validation in a Changing Landscape https://lnkd.in/e-KYzqsC Join Kneat Solutions experts for a roundtable discussion on the changing regulatory landscape in life sciences. We'll dive into key requirements, the move toward risk-based approaches like Computer Software Assurance (CSA), and how digital validation can boost compliance, efficiency, and audit readiness. Walk away with practical insights to help you navigate Pharma 5.0 with confidence!

AI Performance Management In Biologic And Drug Development https://lnkd.in/ed_W7gni - By Fahimeh Mirakhori MSc., Ph.D. Mitigate the AI model performance integrity throughout the product development life cycle.

Addressing Challenges In Automated Visual Inspection Of Lyophilized Vials https://lnkd.in/eTPZc7HA - By sandeep desai, independent subject matter expert Regulatory agencies mandate 100% visual inspection of lyo vials to detect critical defects like cracks, melt-back, and particulate matter.

What FDA Draft Guidance Tells Us About In-Process Control Strategies https://lnkd.in/dzB-C6rM - By Steven Erb, Crown Point Biotech Consulting LLC One of the FDA’s stated missions is supporting and enabling pharmaceutical innovation and modernization, and this guidance appears to reinforce that.