Biosimilar Manufacturing solution center
-
Is The BIOSECURE Act The First Real Step Toward Reshoring?
11/22/2024
The U.S. pharma industry has relied heavily on China and India to produce regulatory starting materials and APIs. The BIOSECURE Act has now emerged. Is this the first real step toward reshoring?
-
Aseptic Filling Solution Enhances Sterility Assurance for Pharma Manufacturer
11/21/2024
Emergent BioSolutions upgraded its Winnipeg site with the Cytiva SA25 aseptic filling workcell to improve sterility assurance, product flexibility, and regulatory compliance for CGT manufacturing.
-
Defining When To Implement Technologies To Support Commercial Growth
11/20/2024
Technology decisions must be understood in the context of your business strategy and projected milestones. With a framework in place, you can define what tech solution you need and when you need it.
-
Integrated Approach In Managing CPV And APQR
11/12/2024
Many companies continue to manually collect data. Utilizing digital technologies can greatly improve productivity and efficiency by enabling real-time monitoring and streamlining regulatory reporting.
-
3 Focus Areas To Transition From Clinical To Commercial Readiness
11/12/2024
Transitioning from clinical-stage operations to commercial readiness is a multifaceted process. Establish compliant and robust distribution systems by focusing on these three areas.
-
CDMO Selection: 7 Steps To Find Your Best Fit
11/11/2024
Selecting the right CDMO for your project is essential. Here is a practical 7-step process, along with key considerations and pitfalls to avoid along the way.
-
A Risk-Based Approach To Filter Integrity Testing Annex 1 Requirements For Biologics DS
11/8/2024
How do the principles of filter integrity testing described in EudraLex Annex 1 apply to low bioburden drug substance manufacturing? And how can using a risk-based approach help?
-
Biopharmaceutical Fermentation Systems' Growing Role In Modern Medicine
11/6/2024
Bioreactors, culture media, growth factors, and sensors are essential to foster microbial or cell growth in optimal conditions.
-
Maintaining Harmony With Your CDMO Using 'The Middle Way'
10/31/2024
Sponsor and CDMO relationships are fertile ground for conflict. A measured approach can mitigate disruptions with troublesome contractors and high performers alike.
-
A Comprehensive Guide For Supplier Quality Agreements
10/29/2024
This overview of SQAs includes a handy matrix template, which is useful for determining who is responsible for managing specific responsibilities.