Insights
webinar
Scale-up and Production of Key lipids used in mRNA Delivery Systems
This webinar will explore the specific requirements for industrializing processes in the production of ionizable lipids and PEG lipids, elucidating concepts to address typical challenges.
webinar
From Conception to Manufacturing. Accelerating Therapies with Curia
In this podcast, we will explore the advantages of partnering with a Contract Development and Manufacturing Organization (CDMO) to navigate the journey from molecule conception to clinical trials, including the expertise, experience, and preparedness...
webinar
Customized mRNA Processing for Improved Therapy Development and Manufacturing
In this GEN webinar, Scott Alderucci will discuss ways of leveraging new technologies and experimental design for an optimized, tailored approach to mRNA therapy development.
white paper
Continuous Flow - An Emerging Alternative
With the growing complexity of drug molecules and the need to involve newer and harsher reaction conditions that were once thought of as unfriendly in process chemistry, continuous flow chemistry and processing offer a proven alternative pathway.
webinar
The Shift Toward US Pharmaceutical Manufacturing
The COVID-19 pandemic brought the global interdependency of pharmaceutical supply chains into sharp focus, exposing weak links and re-igniting discussions around the value of reshoring production. In this webinar we will discuss drivers to consider i...
webinar
Fast-Tracking Drug Development and Scale-Up in the Post-Covid World
The webinar focuses on truncating drug development timelines in the aftermath of COVID-19. The featured speaker emphasizes phase-appropriate development, offering creative solutions and round-the-clock development across various continents.
webinar
RNA Vaccines: Quality Concepts in GMP IVT mRNA Development, Manufacturing & Analytics
This webinar will provide a general overview of mRNA therapeutics design and production and discuss the importance of robust quality systems in the context of GMP production of mRNA therapeutics.
webinar
FDA's Quality Management Maturity Program – Why should CDMOs adhere to the new CDER's Rati
The objective of this webinar is to explore the QMM program and its benefits, including the rating system currently being developed by the FDA’s Center for Drug Evaluation and Research (CDER) to incentivize drug manufacturers to achieve QMM. We wi...
white paper
Resource savings through effective:
Global Trade Compliance in Drug Development
The increasing global trade of pharmaceutical products underscores the need for (bio)pharmaceutical companies to be well-versed in international trade requirements. This white paper explores the impact of factors like the COVID-19 pandemic on global...
white paper
FDA's Quality Management Maturity Program:
Why should CDMOs adhere to the new CDER's Rating System?
Ensuring the safety and efficacy of pharmaceutical products is paramount in the healthcare industry, making the FDA's Quality Management Maturity (QMM) program and CDER's proposed rating system crucial for Contract Development and Manufacturing Organ...
white paper
Bispecific antibodies unleashed
Advances in disease biology have led to the burgeoning development of bispecific antibodies (BsAbs), which are synthetic proteins capable of targeting two discrete epitopes from different antigens. Their bispecific functionality offers promising ther...
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CMC Best Practices: Expediting Orphan Drug Development to Combat Rare Disease
February 28 marks the global observance of Rare Disease Day, a day when we participate in raising awareness and generating change for the global population and their families living with rare diseases.