The PharmTech team focused on its coverage of AAPS PharmSci 360 this week, conducting interviews with experts on a range of topics including formulation platforms, AI, amorphous solid dispersions, and animal studies.
Opinion|Videos|April 29, 2024
Rentschler Biopharma: A 50-year Legacy of Exceptional CDMO Expertise
Author(s)Rentschler Biopharma
Explore how Rentschler Biopharma duels biopharmaceutical innovation, spanning from pioneering biological products to cutting-edge cell and gene therapies
Benedikt von Braunmühl (CEO) and Federico Pollano (vice president of business development) at Rentschler Biopharma explain what sets their CDMO apart. Viewers will learn about:
- What exceptional CDMO expertise means: 25% of all FDA approved biopharmaceuticals in 2023 were supported by the company
- Rentschler Biopharma’s US offerings, as well as commercial and development expertise
- How the company is leveraging its expertise in the field of gene therapy
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Manish Baviskar, Hubot CDMO, on ALCOA++ data integrity, model version change control, continuous monitoring, and human sign-off.
The agreement between CDER and OII with allow for coordinated marketing application assessments and inspections.
Manish Baviskar, Hubot CDMO, explains which AI skills validation engineers need first and why AI model updates must go through GMP change control.
Ron Filler, Drug Development Consultants, explains how USP's 1074 revision brings human-relevant safety science to formulators and excipient makers.
Nitin Kumar Swarnakar, PhD, global application lab manager at BASF, talks about spray drying for drying amorphous solid dispersions and Raman spectroscopy’s role as a quantitative analytical tool.
Aleksandra Zuraw, senior veterinary pathologist at Charles River, discusses how chain of custody, good laboratory practice, quality control, and validation are applied to digital pathology data used in drug development.
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