Insights
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...
webinar
Ensuring Patient Safety: Decoding FDA’s Rating System for CDMOs
To optimize manufacturing process performance and product quality, enhance supply chain reliability, and foster proactive continual improvement, the FDA’s Center for Drug Evaluation and Research (CDER) has established a program to promote quality m...
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
Revolutionizing Small Molecule API Production:
Unveiling the Impact of Fermentation as a Sustainable Solution
While large molecules continue to advance in drug development pipelines, small molecule Active Pharmaceutical Ingredients (APIs) still retain their historical dominance among new drug applications (NDAs). However, the last few years have seen the lin...
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...
article
Lyophilization: Protecting and preserving biologics
Lyophilization, also known as freeze-drying, is often a crucial step in the manufacturing process of biologics drug products. Biologics are large, complex molecules used to treat various diseases, including cancer, autoimmune disorders, and rare gene...
white paper
Rapid discovery and characterization of monoclonal antibodies against the SARS-CoV-2 Delta spike protein
In the fall of 2021, the Delta variant of SARS-CoV-2 was the dominant strain in the US, being both more contagious than previous variants and more likely to lead to “long COVID” than subsequent Omicron variants. Here we describe the discovery and...
article
Overcome a “lack of time” challenge
To say that “our lives are busier than ever” would be a redundant statement. The good news is: we still have 24 hours in each day! Curia’s Director, Learning & Development, Terri Souder-Basa put together a practical guide on how to overcome a...
article
How T3P is helping to advance API development
The right choice of organic reagents early in the synthesis can smooth the path and expediate the journey of lead- to- candidate identification. Curia can produce the green and versatile reagent T3P in a superior purity – and give researchers the f...