Introducing NovaPure® Components

Component manufacturing process designed with Quality by Design principles meets the high-quality needs of pharmaceutical manufacturers and patients

West has introduced a new line of high-quality components under its NovaPure brand at the PDA Annual Meeting. Through a product development process that incorporates Quality by Design principles, NovaPure components, including serum and lyophilization stoppers and syringe plungers, will help to ensure the safety, efficacy and purity of injectable drug products.

“Quality by design is an essential element in helping pharmaceutical manufacturers meet regulatory guidelines for safety and efficacy,” said Donald E. Morel, Jr., Ph.D., West’s Chairman and CEO. “West is embedding QbD in manufacturing from raw materials through delivery. NovaPure components incorporate a variety of high-quality processes and features designed to ensure component reliability and provide an unrivaled level of quality for our customers, which ultimately can aid in the safety and efficacy of their drug product for the patient.”

 

 

 

 

 

 

 

 

 

NovaPure components:

• Help pharmaceutical companies lower total cost of ownership
• Will improve transparency between component and pharmaceutical manufacturers
• Ensure quality driven by patients’ needs
• Are manufactured with the deepest product and process understanding

For NovaPure components, West developed a comprehensive quality target product profile (QTPP) based on the needs of its customers and their end users. Critical quality attributes (CQAs), determined with the patient in mind, have been built into the development process to help ensure quality, safety and efficacy throughout a drug product’s lifecycle. Features and processes that help to ensure reliability include:

• FluroTec® barrier film – a proven, effective barrier against extractables that provides lubricity without the need for silicone oil
• Validated wash and sterilization processes that help ensure consistency of stopper preparation
• 100 percent vision verification to assure low particles
• Lot-to-lot extractable profile to assure material consistency

NovaPure components are available globally with reduced lead time and are provided in optimized packaging that helps ease transition through manufacturing environments. The components are supported by a series of unique service features that help assure the latest compliance and customer satisfaction requirements are met. 

NovaPure and FluroTec are trademarks or registered trademarks of West Pharmaceutical Services, Inc. in the United States and other jurisdictions. FluroTec technology is licensed from Daikyo Seiko, Ltd.

 

The Next Generation Approach to Elastomeric Closures for Sterile Products

The current pharmaceutical market has faced a variety of challenges, including increasing expectations for quality from end-users and regulatory agencies driven by concern for patient safety. While pharmaceutical companies are working to assure that new quality and compliance paradigms are met, a balance must be achieved between the reality of managing costs to provide a product that meets payer’s requirements and facilitating profitability in order to continue adequate business reinvestment.

To balance these priorities effectively, the adoption of Quality by Design (QbD) concepts is gathering momentum within the industry. A process designed with QbD principles requires a significant up-front investment. However, it delivers an improved, data-driven output providing manufacturers with superior product and process understanding that minimizes process risk, emphasizes patient-critical quality requirements and enhances drug product effectiveness. A more efficient and controlled process, results in a final deliverable that is a much higher-quality product with well understood and controlled sources of variation.

The Quality Target Product Profile (QTPP) forms the basis for drug product formulation and process development in a QbD concept. A series of considerations should be made for the QTPP of a sterile product. Some of these considerations include the desired product performance based on the intended clinical setting, dosage strength and delivery mode, pharmacokinetic characteristics, drug product quality criteria, sterility and the container closure system itself, just to mention a few.

Quite often, the container closure system is a final consideration in the drug development process. However, the primary package is critical to the success of drug stability and the effectiveness and compliance of a commercial manufacturing process. Realistically, the QbD framework can be adopted by pharmaceutical industry suppliers in order to provide benefits to the pharmaceutical drug manufacturer.

High-quality components and sterile packaging must be well-understood to provide significant benefit to the overall container closure or delivery system.

Watch for a new product from West based on the QbD concept – coming next week!

 

Fran DeGrazio
Vice President
Marketing & Strategic Business Development
(610) 594-3190
Fran.DeGrazio@westpharma.com

 

Evaluation of residual moisture in lyocakes and corresponding lyophilization stoppers of different rubber formulations

Dr. Heike Kofler, Amy Miller, Jennifer Riter
West Pharmaceutical Services, Inc.

One of the critical success factors for packaging lyophilized drugs is protection against product degradation caused by moisture. Moisture can be introduced into a lyophilized drug product cake from the elastomeric stopper and from the atmospheric headspace; it can also permeate through the stopper, a process known as moisture transmission.

To better understand moisture transmission and retention, West performed a three-year study to determine the effects of autoclave and drying times on residual moisture in lyophilization stoppers. Lyophilized lactose was also evaluated to determine the ability of lyophilization stoppers to protect drug product from moisture absorption.

Lyophilization stoppers have been designed to permit proper lyophilization of drug product in a lyophilization chamber. Prior to packaging the drug product, many of these stoppers are washed and steam sterilized, which may increase moisture content within the stopper, and then dried to drive out the moisture in the stopper. If the drying conditions for the stopper are not optimized, residual moisture can transfer into the lyophilized drug product over time. Lyophilized drug product is often unstable in its aqueous form. Therefore, moisture from the lyophilization stopper may have a detrimental effect on the drug product. This study, conducted by West Analytical Services, was performed to determine the moisture content of lyophilization stoppers exposed to a typical autoclave sterilization cycle and dried for 1, 4, and 8 hours. The lyophilization stoppers were exposed to typical lyophilization parameters to determine if the stopper transfers moisture. The stoppers evaluated were made from two types of chlorobutyl, bromobutyl and butyl base polymers. They were either fluoropolymer laminated (chlorobutyl 1, chlorobutyl 2, bromobutyl, butyl) or non-laminated (chlorobutyl 1). The study should help manufacturers choose a suitable stopper for moisture-sensitive lyophilized drug products.

The data revealed that a 1-hour drying cycle was not enough to remove the moisture driven into the stopper during the autoclave cycle. It was necessary to dry each stopper for at least 4 hours to return the moisture content in the stopper to the amount of moisture prior to steam sterilization. The residual moisture within the stoppers increased over time and leveled off around 18 or 24 months. The moisture content of the lactose increased over time as well and there was a slight increase in the moisture percentage of the lactose from 24 to 36 months. Best results were gained with an 8-hour drying time.

Read the full scientific poster here.

 

West’s Diane Paskiet to Present at PDA Annual Meeting in April

Diane Paskiet, Director, Scientific Affairs, will present at two sessions during the  2012 PDA Annual Meeting.  The meeting will be held from April 16-18, 2012 at the JW Marriott Desert Ridge Resort in Phoenix, Arizona.

On Tuesday, Diane will present “PQRI Activities: Influence on Best Practices in NA and Europe” on Tuesday, April 17 from 4:00-5:30.”  Diane will also present “Drug Product Contact Materials: Stage Appropriate Assessments for Quality Performance,” on Wednesday from 9:00-9:30 a.m.

The Wednesday session will discuss how modern GMP expectations are transforming the way drug products are being developed, manufactured, evaluated and controlled.  The movement from ascertaining product quality predominantly by end product testing to achieving quality by design of effective and efficient manufacturing processes is reinventing the GMP landscape. Drug product formulation development summaries should highlight the evolution from initial concept up to the final design and take into consideration the choice of drug product container closure systems (ICHQ8). While the design features are dependent on the user needs, the selection of contact materials including the fabrication, assembly and filling is contingent on the characteristics of the drug product formulation.

During drug product development multiple changes in manufacturing will likely take place and the contact materials used in development, scale up and commercialization should be qualified for use. The level of evaluation should be appropriate and proportionate to the drug product stage goals. Principles of quality risk management can be applied to assess the materials in contact with drug products through-out the lifecycle. Identification and justification of these key materials and parameters will support drug product safety and efficacy. This presentation will examine critical parameters to be evaluated with regard to primary container/delivery systems recognizing the needs for different stages of the drug product lifecycle.

The 2012 PDA Annual Meeting focuses on science and technology innovation as well as optimized performance, offering extensive formal and informal networking opportunities and providing a forum to contribute to and influence the advancement of science and regulation in the pharmaceutical and biopharmaceutical industry.  This year’s theme centers on Manufacturing Innovation: Achieving Excellence in Sterile and Emerging Biopharmaceutical Technology.

For more information or to register to attend, visit http://pdaannualmeeting.org.

Diane Paskiet
Director, Scientific Affairs
610-594-3401
Diane.Paskiet@westpharma.com

 

Join us in Raleigh, North Carolina for a FREE Educational Seminar!

Want to learn more about quality planning for injectable delivery systems?  Join West’s technical experts on April 24, 2012 at the Renaissance Raleigh North Hills Hotel for a free educational seminar.

The seminar will cover topics such as:

• Understanding Components and the Manufacturing Process
• Efficient Preparation and Sterilization Processes
• Assurance of Quality and Lifecycle Strategies
• Injectable Delivery Systems
• Patient and Caregiver Needs
• Rational Approaches to Sound Science
• Integration of Quality to Mitigate Risk

Where: Renaissance Raleigh North Hills Hotel
                4100 Main at North Hills Street
                Raleigh, NC 27609
                919.278.1474 

When: April 24, 2012
              8:30-4:00

Continental breakfast and lunch will be provided. 

Register now!

We’ll see you there.

 

Quality Solutions Mitigate Total Cost of Ownership

In an earlier post, I discussed how the changing market, regulatory expectations and quality issues have an impact on a pharmaceutical manufacturer’s total cost of ownership.

There are a variety of solutions that are currently available to aid with these issues, and thus lower the total cost of ownership. For example, modern polymeric materials can be considered for primary packaging. In addition, the manufacture and processing of such polymers allows for flexibility in molding and forming throughout a drug product’s lifecycle. This means the drug can be contained in the same material from development through commercialization, which may lower evaluation costs.

High-quality components can also make a difference. Primary container closure systems typically consist of a vial, stopper and seal. Selecting a vial made from a cyclic olefin polymer, such as the Daikyo Crystal Zenith® polymer, and a high-quality, ready-to-use component that has been through optimized washing, sterilization and automated vision verification processes can combat issues from particulate and extractables. Administration systems can be developed using the same combination of materials. The key is to develop a delivery system based on the needs of the patient.

West is always working to find new and innovative solutions to our customers’ needs, and in April, we will introduce a new, high-quality line of elastomeric components that have been developed using Quality by Design principles. Check back with us often for more information.

 

 

 

 

 

 

 

 

 

Fran DeGrazio
Vice President
Marketing & Strategic Business Development
(610) 594-3190
Fran.DeGrazio@westpharma.com

Dookie Days – Part Two: Dookie Makes Herself At Home in the CEO’s Office

There aren’t many employees who would dare to take a nap in the presence of the CEO and other executives. But on Dookie’s first day of work she met West CEO Don Morel and executives Steve Ellers, Jeff Hunt, Rick Luzzi and Bill Federici. After spending a few minutes in Steve’s office, Dookie curled up on the office floor and proceeded to snore.

 

 

 

 

 

 

 

 

Rather than face the stress of CEO life, Dookie stayed with handler Carol Cully. Dookie’s daily activities included attending meetings, going to lunch with co-workers and even appearing on Live Meeting video conferences several times.

 

 

 

 

 

 

 

 

 

 

Learning to go out at specific times became the biggest challenge for Dookie at work. Such training is one of the elements of becoming a service dog. When Dookie needed to go out she would signal Carol by simply resting her head on Carol’s leg.

On most drives home, Dookie would sit in the back seat with her head on Carol’s shoulder so she could wag goodbye to West each night.

To learn how you can volunteer or assist CPL, visit www.k94life.org

Subscribe to our news feed to get more updates about Dookie at West!

Quality Performance of Advanced Cyclic Olefin Plastic Prefillable Syringes

Tibor Hlobik, Director, Prefillable Solutions and Technologies
Mike Gills, Customer Technical Support Process Engineer

Growth in biopharmaceutical therapeutics is leading innovation with prefillable syringe systems. These complex sensitive drug products require highly inert primary packaging materials for improved stability and delivery in perfect quality for reduced safety risk. This poster will provide a quality comparison of primary prefillable syringe options including glass, coatings/laminates and cyclic olefin polymers, and highlight the findings of a case study comparing 1mL long syringe attributes.

In the case study, syringes were 100% inspected and classified for visual defects.  Filled syringes were measured for quantitative particulate levels (including visible and sub-visible), and subjected to simulated transportation conditions.

Syringes made of glass or plastic contain visual defects that are associated with forming and handling. However, Daikyo Crystal Zenith® syringes showed significantly fewer defects than glass, and there was no incidence of broken flanges, a major defect, as compared to glass. It can be expected that when used for pharmaceutical drug product packaging, Daikyo Crystal Zenith syringe technology can offer a reduced level of incoming rejects and end-of-line rejects associated with 100% inspection, and minimizes the risk associated with the cost of poor quality.

Particulate matter in injectable drug solutions consists of extraneous mobile undissolved particles, other than gas bubbles, unintentionally present in solutions. Both glass and plastic syringes can contribute particulate to filled solutions in subvisible and visible size ranges. On average, filled syringes increase in particle loads after transportation simulation. However, Daikyo Crystal Zenith syringe technology contributes significantly less particulate to filled solutions as compared to glass in both pre- and post-transportation conditions, and is expected to reduce particulate contribution to drug products.

For more information on this study, read the scientific poster.

Daikyo Crystal Zenith® is a registered trademars of Daikyo Seiko, Ltd.
Daikyo Crystal Zenith technology is licensed from Daikyo Seiko, Ltd.

 

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 standards are a must to compete and meet today’s challenges. 

Effective packaging selection early in the development process can be key for sterile pharmaceutical manufacturers. Early partnerships help pharmaceutical manufacturers select consistent components that can be used throughout the drug product’s lifecycle and potentially mitigate risk associated with issues such as particles, which can be impacted by an elastomeric component or by the container holding the drug. An example of the latter is glass delamination of vials, which has driven many market recalls in the recent past. Additionally, as delivery systems are utilized to a greater extent with many specialty pharmaceuticals, the ability to assure the packaging and delivery system work together effectively minimizes risk and total cost.

Overall, early partnerships, consistent components and unique delivery systems can help to lower a drug manufacturer’s total costs and mitigate risk when moving a drug to market.

West offers a variety of solutions for its customers. To learn more, visit www.westpharma.com.

 

 

 

 

 

 

 

 

 
Fran DeGrazio
Vice President
Marketing & Strategic Business Development
(610) 594-3190
Fran.DeGrazio@westpharma.com

 

Supply Chain Integrity Reduces Threats of Counterfeit Drug Products

In a recent Flash Report, Rx-360.org offered a summary of the proposed USP Chapter 1083 – Good Distribution Practices – Supply Chain Integrity.  In its report, Rx-360 noted that “globalization of all aspects of the pharmaceutical business has driven the need to address the threats of counterfeit or adulterated medication, devices and components, for which there have been several high-profile examples over the last few years.”

In February, counterfeit doses of Avastin, a cancer drug, were distributed in the United States.¹  Medical practices were informed that the counterfeit versions had several obvious differences in the packaging and labeling, including missing information and altered lot numbers.

Counterfeit drug products represent a growing issue for the health care industry and pose an increasing threat to patient safety.  Securing supply chain integrity can help to ensure that medicines can be traced back to their original manufacturer, are not adulterated or counterfeited and are transported to their intended destination with quality intact.

To avoid use of a counterfeit drug product, the World Health Organization recommends a visual inspection before a drug product is used.²  Signs of a counterfeit problem may include:

·          False or incorrect labeling

·          Improper packaging

·          Evidence of tampering, including unseated stoppers or seals

·          Missing information

West offers several solutions to aid in anti-counterfeiting.  Our tamper-evident Flip-Off^® seals and use of a specific color scheme for a container closure system may help caregivers and end users recognize a product at point of use.

West Spectraproprietary printing and embossing technologies give drug manufacturers multiple layers of  anti-counterfeiting protection and can also provide point-of-use instructions such as cautionary statements at the item level. West also partners with customers to develop custom covert and sophisticated authentication solutions to support anti-counterfeiting programs.

To read the full Rx-360 Flash Report summary, visit http://www.rx-360.org/LinkClick.aspx?fileticket=dDgrRtcJWtw%3d&tabid=165

To download / view the proposed USP Chapter, visit http://www.rx-360.org/LinkClick.aspx?fileticket=-6vLFYkQ7Yo%3d&tabid=165 

Fran DeGrazio
Vice President, Marketing & Strategic Business Development
(610) 594-3190
Fran.DeGrazio@westpharma.com

References:

1 “Counterfeit Doses of Avastin Distributed in the U.S.,” New York Times, Feb. 14, 2012, accessed on March 6, 2012. http://www.nytimes.com/2012/02/15/business/counterfeit-doses-of-avastin-distributed-in-the-us.html

2 World Health Organization’s International Medical Products Anti-Counterfeiting Taskforce (IMPACT), “Be Aware Toolkit for healthcare professionals,” http://www.who.int/impact/news/beaware/en/index.html, accessed on March 6, 2012.