Resources

Welcome to 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

White Papers

Leak Rate Testing for Freeze Dryers

A study was performed to use a more scientific approach to establish leak rate acceptance criteria.

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Publications

Residual 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.

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Publications

Stability 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.

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Publications

Test Methods and Quality Control for Prefilled Syringes

Both empty and filled syringes must pass a range of tests.

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Publications

Seasonal 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?

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Publications

Prefilled 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.

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Publications

Using 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.

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Publications

Outsourcing 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.

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Publications

Prefilled Syringe Automated Inspection & End-Product Testing

This article introduces the common equipment available for automated inspection and discusses inspection testing methods for prefilled syringes.

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Publications

Impact 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.

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Publications

Putting 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.

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Publications

Application of QbD and QRM to Analytical Method Validation

A case study of a stability-indicating method for Protopam.

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