Lifecycle Planning

It can take more than 12 years and a major financial investment to bring a drug product to market.1 A drug product’s success relies on its efficacy, safety and manufacturing efficiencies along with the use of innovative strategies to meet evolving market needs and reinforcement of  patient adherence. The importance of container closure and delivery [...]

Introducing Tech Talk

Welcome to Tech Talk, our latest feature from blogger Beverly Prohaska, Vice President, Global Information Systems.  These features will discuss how West uses information technology internally and externally to help ensure customer satisfaction.  Look for Tech Talk to appear regularly on the West blog. At West, we believe that having transparency to what’s most important to [...]

Partnerships Help Build Integrated Delivery Systems

The number of biologic drug products marketed with an injection device has approximately quadrupled over the last decade. The growth in these drug therapies has been driven by several factors including new, self-administered therapies for chronic conditions such as rheumatoid arthritis and autoimmune diseases. In addition, injectable therapy is now being considered as a treatment [...]

Managing Total Cost of Ownership in a Changing Market

In 2012, the pharmaceutical industry will face many challenges, not the least of which will be the need to adjust research and development and business models to respond to the growing importance of specialty pharmaceuticals. Such products include sensitive biopharmaceuticals and the growth of biosimilars. Efficiency in manufacturing and the ability to meet critical compliance [...]

Screening Analysis Can Assure Proper Packaging Selection

According to the Code of Federal Regulations Title 21 Food and Drugs Part 211.94(a) Subpart E Control of Components and Drug Product Containers and Closures, drug containers must not react or add to a drug product in a way that alters the drug’s safety or quality. Concerns related to the packaging system can include: – [...]

Selecting the Proper Elastomeric Formula

Because your drug product has direct contact with the container closure system (vial and stopper), it is critical to consider compatibility factors of the rubber formula when selecting a stopper for your drug package. It is possible for a drug product to become contaminated if the drug and components react chemically. The substances that may [...]

Visual Inspection Can Help Spot Counterfeit Drug Products

Counterfeit drug products represent a growing issue for the health care industry and pose and increasing threat to patients.  The problem is so prevalent that the World Health Organization has established the International Medical Products Anti Counterfeiting Task Force (IMPACT) to combat counterfeit drugs on a global level. In its BEWARE Toolkit for health care [...]

Scaleable Pharmaceutical Packaging Systems for Cell Therapy

Daikyo Crystal Zenith Vials: A Sterile System for Cryogenic Applications The development of cell-based therapies for many debilitating diseases including Parkinson’s and Alzheimer’s can make an undeniable impact on a patient’s quality of life. Many current cell-based products are produced, frozen, stored and delivered to the clinical site in intravenous (IV) bags or polypropylene screw-cap [...]

Creating a Verification Process, not an Inspection Process

West’s Peg Frandolig, Technical Customer Support Manager, recently presented “Creating a Verification Process, not an Inspection Process” at the PDA 2011 Visual Inspection Forum, Oct 3-6, 2011. Good pharmaceutical practice requires the individual physical inspection of drug product container closure systems in order to reject those showing evidence of contamination with visible foreign material. Drug products in [...]

Rx-360 Launches Audit Sharing Program

West’s Andy Polywacz, Vice President of Quality, Americas, was recently quoted regarding the new Rx-360 Audit Sharing Program. According to a recent Rx-360 press release, the Audit Sharing Program collects and shares audits conducted by member companies on suppliers. Benefits of the program may include a broader “picture” of Quality Culture and performance and the [...]