Resources
Welcome to Simtra BioPharma Solutions’ Educational Resources Center. This library provides educational and informative resources to help you learn more about the latest trends, topics and state-of-the-art solutions for parenterals.
Resources
Leak Rate Testing for Freeze Dryers
A study was performed to use a more scientific approach to establish leak rate acceptance criteria.
View resourceResidual Moisture Determination in Lyophilized Drug Products
An overview of common residual moisture methods for lyophilized drug products and key points to consider during method selection and method development.
View resourceStability Indicating Methods for Aluminum Adsorbed Vaccine Products
The authors provide an introduction to aluminum adsorbed vaccines, review studies of antigen stability, and propose test methods for the analysis of aluminum vaccine release and stability analysis.
View resourceTest Methods and Quality Control for Prefilled Syringes
Both empty and filled syringes must pass a range of tests.
View resourceSeasonal Vaccine Manufacturing
Successful contract manufacturing of seasonal vaccine products requires the right facility, culture, and expectations to help ensure quality and on-time delivery. What should sponsors look for?
View resourcePrefilled Syringes & Parenteral Manufacturing: Flexibility for Faster Development
This annual Drug Development & Delivery special feature highlights contract manufacturers and device developers responsible for creating next-generation parenteral drug delivery.
View resourceUsing a Risk-Based Approach to Manufacturing in a Multi-Product Facility
At its plant in Halle/Westfalen, Germany, Baxter BioPharma Solutions has implemented a risk-based approach to addressing those challenges, providing customers with the benefits of multi-product manufacturing.
View resourceOutsourcing Formulation Development & Manufacturing: CDMOs Are Innovating for 21st-Century Medicine
In this annual report, some of the industry’s leading CDMOs talk about the innovations they are developing for next-generation patient care, and how many are making investments that are enabling them to offer more services under one roof.
View resourcePrefilled Syringe Automated Inspection & End-Product Testing
This article introduces the common equipment available for automated inspection and discusses inspection testing methods for prefilled syringes.
View resourceImpact of PFS and Filling Process Selection on Biologic Product Stability
The author discusses the impact of prefilled syringe product contact materials and the filling and stoppering process on protein aggregates.
View resourcePutting the Pieces Together: Are the Components in Your Prefilled Syringes Compatible?
While a prefilled syringe can offer advantages for biologic products, manufacturers must carefully evaluate compatibility.
View resourceApplication of QbD and QRM to Analytical Method Validation
A case study of a stability-indicating method for Protopam.
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