Articles, App Notes, Case Studies, & White Papers

31. Reformulation Of A Complex, High-Drug-Load, Modified Release Dosage Form 4/5/2021

    What if you could limit and position a formulation change as only a CMC prior approval supplement under the FDA’s scale-up and post-approval changes guidance?

32. The Importance Of A Human Centered Approach To Product Development

    To meet the needs of patients, life-saving device innovations are needed for the next generation of delivery devices. As drug manufacturers explore the device world, human factors are a key consideration.

33. NovaPure Stoppers - The Right Choice For Oncology Drugs

    Vial containment systems with NovaPure® elastomer stoppers offer substantial performance benefits with their enhanced dimension control, reduced particle levels, inspection of every stopper, and use of FluroTec® film. Explore the performance of the film and why NovaPure stoppers should be the choice for sensitive drug products.

34. Taking A Best Practice Approach To Contamination Control  9/21/2025

    Implementing the EU GMP Annex 1 requires a holistic, evolutionary Contamination Control Strategy built on standardization, data analytics, and continuous improvement for a zero-defect mindset.

35. Best Practices For Ensuring Quality In Biologic Products

    New biologic therapies have new challenges in their packaging and delivery systems because of their complexities, higher stability risks, and larger sizes. 

36. Nanoformed API: A Superior Alternative To Solid Dispersions 7/29/2024

    Cutting-edge nanotechnology is now emerging, able to address bioavailability challenges and deliver higher drug loads in more patient-friendly formats with fewer and smaller pills and easier regimens.

37. Lyophilization Contract Manufacturing Services: What To Know 3/7/2023

    Explore the best ways to optimize your lyophilization cycle and the benefits of partnering with an experienced pharmaceutical contract manufacturing services provider.

38. Pharmaceutical Nanotechnology: What To Know 8/10/2022

    Here is what you need to know about the key advantages that pharmaceutical nanotechnology provides in improving drug efficacy and decreasing adverse reactions.

39. Driving Sustainability In Spray Drying Through Enabling Technologies

    By transitioning to alternative solvents or leveraging process aids, the challenges associated with the use of these chemicals can be addressed, helping create a sustainable, greener footprint.

40. Streamline Early-Stage Development To Reach The Clinic Faster 7/17/2023

    Early-stage development is an iterative process, continuously generating new data and insights to optimize the product based on emerging knowledge.