Pharmaceutical Packaging White Papers & Articles
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Integrating Clinical Supply Systems & Outsourced Service Providers Whitepaper
4/28/2011
Pharmaceutical and biotech companies of all sizes are increasingly turning to third parties to execute some or all of their clinical supply activities.
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Mastering The Extended Clinical Supply Chain Whitepaper: Strategic Advantages For Clinical Trials
4/28/2011
The core of any good clinical supply chain system is a supply management system that addresses all of the nuances of clinical supplies.
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Improving Pharmaceutical Manufacturing Regulatory Risk
3/15/2011
Pharmaceutical manufacturers must manage regulatory risk to ensure products are developed and produced in manner consistent with organizational goals and strategic objectives. Ongoing operations and marketplace supply can be hindered if a producer is not keenly aware of the regulatory environment and potential risks of underperforming processes. Operational requirements for development of clinical supply may also be adversely affected when regulatory issues exist. Similarly, drug development may be hindered by poorly performing production processes for managing laboratory testing, facilities and systems, quality and packaging/labeling. By ACSYS, Inc.
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Article: The 'Rogue' Biologist Speaks His Mind
3/6/2011
Synthetic biology is one of the hottest and most rapidly growing new fields in life sciences. By Cliff Mintz Ph.D., Life Science Leader magazine
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Article: Improving Pharmaceutical Manufacturing Regulatory Risk
3/15/2010
Pharmaceutical manufacturers must manage regulatory risk to ensure products are developed and produced in manner consistent with organizational goals and strategic objectives. Ongoing operations and marketplace supply can be hindered if a producer is not keenly aware of the regulatory environment and potential risks of underperforming processes. Operational requirements for development of clinical supply may also be adversely affected when regulatory issues exist. Similarly, drug development may be hindered by poorly performing production processes for managing laboratory testing, facilities and systems, quality and packaging/labeling. By ACSYS, Inc.
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Article: The 505(b)(2) Alternative - An NDA that Saves Time and Money
6/27/2006
Time is money – a fact well understood by those in the pharmaceutical industry, where developing a new product can take almost a decade and cost hundreds of millions of dollars...
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Gaps In Reconstitution Process Filled By Water-For-Injection Syringe
The recent rise in biopharmaceutical drugs has sparked renewed interest in lyophilization as a way to bring injectable biologics and other drugs to market more quickly.
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5 Must-Haves In A Contract Packaging Partner
A contract packaging partner should function as an extension of the pharma’s organization, so careful consideration should be devoted to initiating this relationship.
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FDA Requirements For Packaging Cryogenically Frozen Advanced Therapies
FDA requires packaging and distribution systems to protect the agent from contamination and damage. In distributing cryogenically frozen advanced therapies, this includes protection from temperature shock.
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Four Reasons For The Rise In Blister Packaging
Here are the factors that are driving blister to the forefront of pharmaceutical packaging, and at an even faster rate than its current growth.