White Papers
-
Combining Digital Platforms And QbD Principles
7/9/2024
How can data and digitalization further improve pharmaceutical development and the continuous, quick, and efficient delivery of products?
-
Revolutionizing Manufacturing For Pharma And Biopharma
7/9/2024
Explore the evolution of Industry 4.0 in pharmaceutical manufacturing, the benefits and implications of Smart Factories, and the challenges along the road toward implementing a Smart Factory.
-
ICH Q12 Implementation: Regulatory Intelligence And PACM Agility
7/9/2024
Here, we outline a practical framework designed to assist companies in implementing ICH Q12 from day one, enabling them to realize its benefits early on and paving the way for continuous improvement.
-
Best Practices In Commissioning And Qualification
7/5/2024
An integrated approach to C&Q ensures coordination and synchronization between commissioning and qualification activities, enhancing both regulatory compliance and product safety.
-
Rapid, Seamless Upstream Process Development And Scale-Up For CHO-K1 Cells
6/28/2024
Accelerate your biotech company's scale-up process while delivering consistent and strong cell growth, productivity, and product quality.
-
Mitigating Nitrosamine Risks In Pharmaceuticals
6/25/2024
Nitrosamines can come from a range of sources, including raw materials, manufacturing processes, and even water sources. Detecting them requires sensitive analytical methods.
-
A New Framework For Identifying Nitrosamine Risks And Efficiently Derisking Products
6/18/2024
Examine a new methodology that holds significant promise for identifying APIs at risk for NDSRI formation, enabling manufacturers to prioritize risk mitigation strategies and ensure compliance.
-
20 Years Of Biosimilars: Are We On The Right Track?
6/17/2024
Explore the transformative journey of biosimilars, 20 years in. Through industry expert insights collected from a recent panel discussion, explore regulatory hurdles, market shifts, and the path ahead.
-
Microbial Challenge In-Use Studies
6/13/2024
Learn more about how a partner with expertise can help you navigate the complex landscape of microbial challenge in-use studies and ensure the highest standards of patient care.
-
Revolutionizing Drug Discovery From "Undruggables" To AI
6/10/2024
Explore four current trends in drug discovery, how each trend addresses some of the most crucial challenges in drug discovery, and the obstacles to their widespread adoption.