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BioPharma Solutions BioPharma Solutions
Sterile Contract Manufacturing

Publications

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In this section, you will find articles on sterile manufacturing, parenterals, outsourcing and more. Our library of useful published articles is updated regularly to help you get the latest on Baxter’s contributions and developments.

Description

Manufacturing in multi-product facilities affords numerous advantages, but also presents significant challenges. 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.

Author/Contributor

Peter Boeddeker, Director of Quality Management, Baxter BioPharma Solutions

Publication

Pharma’s Almanac

Description

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.

Author/Contributor

Gregory Sacha, PhD, Senior Research Scientist, Baxter BioPharma Solutions

Publication

Drug Development & Delivery

Description

The numerous requirements for product inspection and evaluation require expertise. This article introduces the common equipment available for automated inspection and discusses inspection testing methods for prefilled syringes.

Author/Contributor

Gregory Sacha, PhD, Senior Research Scientist, Baxter BioPharma Solutions

Publication

Drug Development & Delivery

Description

The author discusses the impact of prefilled syringe product contact materials and the filling and stoppering process on protein aggregates.

Author/Contributor

Wendy Saffell-Clemmer, Director of Research & Development, Baxter BioPharma Solutions

Publication

BioPharm International

Description

While a prefilled syringe can offer advantages for biologic products, manufacturers must carefully evaluate compatibility

Author/Contributor

Wendy Saffell-Clemmer, Director of Research & Development, Baxter BioPharma Solutions

Publication

PDA Letter

Description

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

Author/Contributor

Wendy Saffell-Clemmer, Director of Research & Development and Jacquelyn Karty, Research Scientist, BioPharma solutions

Publication

Pharmaceutical Technology

There is now a wide range of prefilled syringe options to suit different requirements, which can make product selection a challenge. BioPharma Solutions’ Director of R&D looks at what advances are currently being made.

Author/Contributor

Wendy Saffell-Clemmer, Director of Research & Development, BioPharma Solutions

Publication

On Drug Delivery

After operating in the parenteral therapeutics space for years, Baxter BioPharma Solutions' expertise in sterile injectables has only grown—with the potential to expand into biosimilars.

Author/Contributor

Meg LaTorre Snyder, Author, Editor (Marie Keeley, VP, BioPharma Solutions, Contributor)

Publication

Pharmaceutical Processing

The design of Baxter BioPharma Solutions’ aseptic filling lines provides a case study in customizing containment systems for multi-product lines

Author/Contributor

Frank Generotzky, Plant Manager, BioPharma Solutions, Martin Tuckermann, PhD, Project Manager, BioPharma Solutions

Publication

Pharmaceutical Technology

A glimpse of some of the challenges faced during the development of viscous formulations of biopharmaceutical products for injection, from a formulator’s perspective, especially when the finished product is filled in a prefilled syringe

Author/Contributor

Mahesh Chaubal, PhD, Senior Director, Drug Development, R&D Medical Products, Baxter Healthcare Corporation

Publication

ONdrugDelivery

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