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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

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

Trends in biopharmaceutical manufacturing/outsourcing

Author/Contributor

Bradley Newman, Sr. Director of Marketing, Baxter BioPharma Solutions

Publication

Pharmaceutical Outsourcing

Supplying the latest research on the formulation, manufacture, quality control, and regulation of pharmaceuticals, biopharmaceuticals, and related products, this reference contains up-to-the-minute chapters on contamination control, facilities management, inspection, distribution, GMP, sterility and stability testing, and aseptic environments.

Author/Contributor

Michael J. Akers, Ph.D., Senior Director of Pharmaceutical Research and Development at Baxter

Publication

Informa Healthcare, Publisher

QUALITY CONTROL - High-Temperature Stability | Do the Math for Shelf Life

Keys to understanding the temperature relationships and the ability to more accurately predict the expected long-term levels for a specific product.

Author/Contributor

Michelle Duncan, PhD, and Irene Zaretsky, MS

Publication

Pharmaceutical Formulation and Quality

Tech Corner:  Handled with Care

A machinery manufacturer takes the time to understand a cytotoxic drug filling line in order to deliver a solution offering heightened control and safety.

Author/Contributor

Frank Generotzky, Director, Technology & Engineering

Publication

Pharmaceutical & Medical Packaging News

Baxter – Medical Device Company of the Year

PM360 chooses Baxter as Medical Device Company of the year (Trailblazer Award) and cites Baxter’s commitment to medical innovation, sustainability, and high ethical standards

Author/Contributor

Bruce Lacey

Publication

PM360 Trailblazer Awards issue

Strategies for Becoming a Preferred Provider

A roundtable discussion of the growing emphasis throughout the pharmaceutical outsourcing arena on being a strategic, or preferred, provider.

Author/Contributor

Brik Eyre

Publication

Pharmaceutical Technology special issue

Safety Considerations for High Potency Manufacturing

What to keep in mind with HPAI outsourcing

Author/Contributor

Frank Generotzky, Director, Technology & Engineering

Publication

Contract Pharma

Lifecycle Management for Injectable Brands - Timing is Everything

Effective positioning of a molecule through Lifecycle Management (LCM) strategies can maximize a company’s investment and optimize positioning relative to the competition, the primary strategic imperative for brand managers.

Author/Contributor

Kristie Zinselmeier, Director, Marketing

Publication

PM 360

Ensure Safety, Efficacy of Ready-to-Use IV Products

Insight on key stability considerations in the development of ready-to-use products.

Author/Contributor

Paula Youngberg Webb, MS;
Rao Chilamkurti, PhD

Publication

Pharmaceutical Formulation and Quality

Moving from Vials to  Prefilled Syringes:  A Project Manager’s  Perspective

An in-depth look at the complex issues involved in switching an injectable presentation from a liquid or lyophilized vial to a prefilled syringe, as well as a potential regulatory strategy.

Author/Contributor

Raul Soikes, Sr. Director, Project Management

Publication

Pharmaceutical Technology, Supplement on API Synthesis and Formulation 2009

The Keys to RTU  Parenterals

An examination of the challenges related to formulation development of ready-to-use products.

Author/Contributor

Paula Youngberg Webb, MS;
Rao Chilamkurti, PhD

Publication

Pharmaceutical Formulation & Quality

Elements of Quality by  Design in Development and Scale-Up of Freeze-Dried Parenterals

A key concept in the quality by design paradigm is design space.

Author/Contributor

Dr. Steven Nail;
Jim A. Seares

Publication

BioExecutive International

Practical Technologies  for Lyophilization

Understanding and Controlling Process Parameters Is Essential to Success

Author/Contributor

Lakshmi Kamath, PhD

Publication

Genetic Engineering & Biotechnology

ISPE Facility of the  Year

An in-depth look at Baxter’s Bloomington, Indiana, USA, facility vial and syringe filling expansion.

Author/Contributor

n/a

Publication

Pharmaceutical Engineering

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