Pharmaceutical Technology Featured Whitepapers
December 2009

Featured Whitepaper
Avoiding Project Delays Caused by Formulation Changes
Author: John G. Augustine, Ph.D.

Sponsored By: SP Formulations

A white paper from SP Formulations, titled “Freeze! Avoid Catastrophic Project Delays Caused by Formulation Changes”, presents some of the problems associated with ‘simple’ formulation changes. Additionally, the paper presents a case study detailing alternative approaches available for formulating a lyophilized product.

 
Manufacturing
   
  Information Technology
   
 
ERP Strategies and Best Practices for Emerging Life Science Companies
Sponsored by: CDC Ross Enterprise
Savvy business and financial managers in today’s emerging Life Science companies increasingly recognize the need to establish an effective business infrastructure early in the lifecycle of the company. These managers recognize the inherent advantages to establishing scalable business processes and information systems early in the companies’ growth. In support of its present and future customers, CDC Software sponsored this white paper to help emerging Life Science companies understand the ERP strategies and best practices being pursued by leading companies in the industry. Through the experiences of two of the customers highlighted in this paper, emerging Life Science companies can learn from and apply some of the best practices and lessons learned from peer companies.
 
Protect Your Scientific Intellectual Property: Proof of Lab Informatics Data Authenticity is Your Best Legal Defense
Sponsored By: Surety, LLC
As a pharmaceutical or biotechnology organization, your formulas, treatments and clinical findings are the "lifeblood" of your business. But if you aren't protecting the integrity of your scientific data in your lab informatics systems, you risk losing ownership, revenue and consequently your business if you can't prove time-of-creation and authenticity. Learn how you can implement simple, cost-effective, and automated controls to protect your scientific intellectual property.
 
Manufacturing
   
  Outsourcing
   
 
Topical Dermatological Formulation Development – “Things You Should Know”
Author: Vanlee Waters M.B.A., Marketing Manager, Dow Pharmaceutical Sciences, Inc.
Sponsored By: Dow Pharmaceutical Sciences, Inc.
“Things You Should Know” will answer many of your questions and will provide insight into issues you may not have considered -- but should be aware of when developing a topical formulation. The target product profile, dosage form selection, reasons for multiple excipients, the formulation development process, prototype screening, and lead formulation selection are discussed.
 
Outsourcing
   
  Packaging
   
 
TECHNICAL TRANSFER DOCUMENTATION IS KEY FOR SUCCESS
Author: Tom Hughes
Sponsored By: Carton Service-Packaging Insights

Clearly defined objectives and project requirements between the pharmaceutical company and their contract packager need to be spelled out – in writing – in a Technical Transfer Document prior to any pharma packaging project. A published report documenting details for the customer and the packager is a critical component for success.
 
Achieve OEE with a Perfect Induction Seal
Author: Ryan Schuelke
Sponsored By: Enercon Industries

Achieve a perfect induction seal every time and improve OEE (Overall Equipment Efficiency) by understanding how to address and control induction sealing variables. Learn the process of developing a perfect sealing solution by matching the cap, liner and sealer; setting up an operating window and establishing testing methods for identifying a good seal.
 
 

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