Insights
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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...
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Outsourcing Your Parenteral Manufacturing – Choosing the Optimal CDMO
When a drug substance requires a parenteral formulation to administer it, there are key factors to consider when choosing the ideal CDMO partner.
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The M.O. Behind Choosing a CDMO: Three Considerations for New Drug Developers
For many who are new to drug development, the greatest challenge is not necessarily discovering a blockbuster molecule—it’s finding a team capable of carrying that molecule through the complexities that lie between the research lab and the patien...
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Casual Nexus – Episode Four: Strategies for HPAPI Containment to Enable Rapid Development and Production
Presented by Brian Haney, Ph.D., Director of Technical Operations, Curia Iain MacGilp, Ph.D., Director, GMP Production, Curia Listen in as our experts discuss: The basics of handling HPAPI's safely in GMP production settings The trad...
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Casual Nexus – Episode Three: Sterile Drug Product Manufacturing During a Global Pandemic
Presenters: Ankit Agrawal, Senior Director, Commercial Strategy, Curia Anish Parikh, Vice President, Drug Product Sales & Marketing, Curia Listen in as our experts discuss: The shortage of sterile manufacturing capacity within CDMOs given...
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Casual Nexus – Episode One: Formulation Development and Clinical Supply of Aseptic Liposomal
Presenters: Iain MacGilp, Ph.D., Director, GMP Production, Curia Amber McFarlane, Head of Formulation Development, Curia Listen in as our experts discuss: The importance of an integrated formulation development and clinical supply function th...
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Curia Signs on to Participate in Diversity Lab’s Mansfield Certification Program
As part of our deep commitment to diversity and inclusion in the workplace, Curia is very proud to be participating in the two-year Mansfield Rule: Legal Department Edition (MRLD) initiative.
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Essentials of an Industry-Leading CDMO Partner for Highly Potent Projects
CDMOs that routinely handle highly potent compounds must raise the bar for containment, safety, and industrial hygiene. Diverse capabilities across chemistries, purification technologies, and analytical techniques — combined with the ability to sup...
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Prefilled Syringes & Biologics: The Perfect Partnership of Medicine & Delivery
It is no coincidence that the booms in prefilled syringes (PFS) and biologic medicines are happening at the same time – the two are intrinsically linked. Innovative biologic medicines demand innovative delivery systems to match, and as the utility...
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Overcome Common Pre-Filled Syringe Challenges through Partnership
The pre-filled syringe (PFS) space is one of the fastest growing pharma sectors, expected to be worth $9.7bn by 2025, or 9% CAGR. Compared with traditional vial delivery systems, PFS offers greater patient safety and lower manufacturing costs – bu...
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Five Ways Pre-filled Syringes Contribute to Better Patient Outcomes
Syringes have been a mainstay of drug delivery for decades – but, as with many other aspects of healthcare, they have recently undergone something of a revolution. The growth of biological medications, the ever-increasing focus on safety, and a...
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Considerations in Developing Complex Parenteral Formulations
Parenteral formulations are broadly characterized as sterile solutions, suspensions, emulsions, and powders for reconstitution for injection or infusion; they are administered directly to subjects, entering the systemic circulation and typically prov...
