Reducing Leachables by Selecting the Most Effective Container Closure

Beginning in 1998, when an increase in the incidence of pure red cell aplasia (PRCA) was observed in patients with chronic renal failure and associated with the subcutaneous use of Eprex® (epoetin alpha), the U.S Food and Drug Administration (FDA) and European regulatory agencies have paid special attention to leachables in drug products especially resulting from uncoated primary elastomer components.

Current thinking is that biologics may deserve special consideration when selecting a container closure system, because of drug complexity and protein stability challenges, the fact that routine testing may not detect finite changes in the protein and the efficiency of proteins to solubilize leachables.

Pharmaceutical and biopharmaceutical companies can avoid risk and improve drug safety by evaluating several factors critical to primary containment:

  • How does the selected container closure system impact drug stability over time?
  • Can product quality be associated with a leachables profile?
  • Have acceptable levels of leachables over the shelf life of the product been clearly defined?

With increasing concerns on leachable-related drug product safety, it is especially relevant that West has applied FluroTec® fluoropolymer film barrier to many of its plunger and stopper offerings to deliver a premium solution to customers.

The Eprex issue has been a major milesone for many companies to realize the benefit of FluroTec stoppers and plungers for biologics. On an annual basis, more than 260 million FluroTec plungers are used on marketed drugs delivered in glass syringes or Daikyo Crystal Zenith® syringe systems.

West is proud of its proven regulatory and market track record evidenced through components with FluroTec barrier film. All of the top 35 biologics in a vial or syringe rely on West and Daikyo components with FluroTec Film for barrier properties against potential extractables and formation of leachables. To learn more, visit the West Pharma website.

Author:

PEOP WEMP Hlobik Tibor 255 LREZ

Tibor Hlobik
Global Marketing Director
PFS Platform

EPREX is a registered trademark of CENTOCOR ORTHO BIOTECH INC for epoetin alfa injections.

FluroTec® is a registered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.

FluroTec® technology is licensed from Daikyo Seiko, Ltd.

 

 

Visit West at Upcoming Events

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West is excited to announce where you can find our thought leaders in the coming months. Stop by at one of these events to learn what West products are all about and how we’re striving to be by your side for a healthier world.

World Vaccine Congress
April 7-9
Washington, D.C.
For more information or to register: http://bit.ly/1ydq8X9
Visit West at Booth #41
Speaker: Zach Marks

Interphex
April 21-23
New York, NY
For more information or to register: http://www.interphex.com/
Visit West at Booth #1106
Speakers: Jen Riter and Andy Polywacz

SMI Prefilled Syringes
April 27-28
Iselin, NJ
For more information or to register: http://bit.ly/1HO07mq
Speaker: Royce Brockett

West Educational Series
May 6
Grounds for Sculpture
Hamilton, NJ 08619
Registration coming soon

PDA Packaging Conference
May 18-19
Baltimore, MD
For more information or to register: http://bit.ly/1BOpcZm
Co-Chair: Diane Paskiet
Speaker: Andrea Straka

ISCT Annual Meeting
May 27-30
Las Vegas, NV
For more information or to register: http://www.isct2015.com/
Visit West at Booth #516

AAPS National Biotechnology Conference
June 8-10
San Francisco, CA
For more information or to register: http://aaps.org/nationalbiotech/
Visit West at Booth #200 

MD&M East
June 9-11
New York, NY
For more information or to register: http://www.mdmeast.com
Visit The Tech Group at Booth #1839

Pharmapack North America

June 9 -10
New York, NY
For more information or to register: http://www.pharmapackna.com/
Speakers: Chris Evans and Diane Paskiet

West Wins in Four Categories at the 2015 CMO Leadership Awards

On March 18 in NYC, West Pharmaceutical Services, Inc. was recognized as a leading Contract Manufacturing Organization (CMO) among emerging biotech companies (EBT) at the 2015 CMO Leadership Awards.

Based on industry research conducted by Nice Insights, West ranked in the top 10% by EBT companies in the following perception categories:

  • Innovation—delivering on agreed objectives
  • Quality—indicating that the company is reputable and compliant
  • Productivity—treating a project as if it was the company’s own
  • Regulatory—meeting all project milestones and timelines

“West is honored to receive this recognition from our customers,” said Graham Reynolds, Vice President, Marketing and Communications, Pharmaceutical Delivery Systems. “West partners with drug manufacturers to improve the lives of patients by designing and manufacturing innovative, high-quality drug packaging and delivery systems, that bring drugs from concept to the patient more efficiently, reliably and safely. The emerging biotech customers are among our customers who are seeking the highest quality of product to ensure the packaging, delivery and manufacture of their product is done in a way to maintain the highest levels of drug purity possible, given the sensitive nature of biologic drugs, so we are particularly gratified to receive this recognition.”

The CMO Leadership Award was developed by Life Science Leaders Magazine after hearing from readership about their struggles in vetting CMO partners. Winning a 2015 CMO Leadership Award reflects the fact that executives responsible for making or influencing outsourcing decisions at pharmaceutical and biopharmaceutical companies identified West as a leading CMO.

In addition to West’s overall focus on providing a comprehensive range of packaging and delivery solutions to our customers, West also provides contract development and manufacture through its company The Tech Group—a process driven, global contract manufacturer of pharmaceutical and medical devices. With eight locations in North America and Europe, The Tech Group is focused on serving the needs of healthcare companies by providing a single-sourced solution from product conceptualization and rapid prototyping through high-volume manufacturing and final packaging.

The CMO Leadership Award ceremony occurs annually in New York City. This year’s event took place during Drug, Chemical & Associated Technologies (DCAT) Week, of which West was a key sponsor.

 

 

 

 

Plunger Selection Critical for Dose Accuracy and Efficacy

​With more injectable biologics coming onto the market, and an increase in combination products, regulatory scrutiny is being given to the interaction between a drug product and its container closure system. If the right container closure and device are not selected for a biologic that is marketed in a prefilled syringe or auto-injector, there could be a significant impact on quality.

Incompatibility between a drug and its container closure system could present risk of:

  • Drug instability
  • Extractables and leachables
  • Incomplete injections during administration

Any of these issues could potentially compromise patient safety. They could also lead to a delay in regulatory filing, increased program costs and loss of market share. As more attention is paid to the integration of primary drug containers and drugs with devices to form combination products, finding solutions to these problems has taken on an increased urgency in order to protect patients by assuring the integrity and proper delivery of drug products especially complex higher viscosity biologics.

Choosing the right components for a prefilled syringe fit for an auto-injector is a key part of ensuring drug quality and safety. Plunger design, dimensions, sterilization technique and the type of lubrication coatings all impact the performance of a drug delivery device.

At West, patient needs drive quality in all of our components. High-quality NovaPure® components are designed for biologics and sensitive drug products and provide optimized performance for use in prefilled syringes and auto-injection systems. We develop our NovaPure® plungers and stoppers with holistic Quality by Design principles around patient needs to help ensure the efficacy and purity of a drug product and with the patient.

Author:

PEOP WEMP Hlobik Tibor 255 LREZ

Tibor Hlobik
Director, Marketing, PPS PFS, Marketing Administration

West to Present Drug Delivery and Packaging Innovations at the Parenteral Drug Association Annual Meeting

West Pharmaceuticals will participate in two poster presentation sessions at the Parenteral Drug Association (PDA) Annual Meeting, taking place March 16-18, 2015 in Las Vegas. During the meeting, West will also showcase innovations in integrated drug packaging and delivery systems that help ensure the quality, safety and efficacy of injectable drug products for pharmaceutical and biotechnology manufacturers worldwide at booth #405.

West Presentations:

  • “Selecting and Verifying Integral Packaging Systems for Injectable Drug ProductsMarch 16, 10:00 – 10:45 a.m., 3:15 – 4:00 p.m. Kristine Davidson, Technical Account Specialist at West, will present a process for evaluating the compatibility of vials and elastomeric closures in order to maintain drug product sterility and help ensure container closure integrity.

 

  • Filtration as a Means to Remove Glass Particles From Liquid Medications”March 17, 10:00 – 10:45 a.m., 3:15 – 4:00 p.m. Elinor Zarour-Shalev, Mechanical Engineer at West, will present a filtration technique to remove glass particulates caused by delamination using West’s Vial Adapter, a needle-free solution for the safe and rapid transfer and reconstitution of drugs between vials and syringes.

“High-quality packaging systems are essential for any drug product. If the drug product reacts chemically with the containment materials or cannot be effectively stored, it may not be safe or effective for the patient,” said Fran L. DeGrazio, Vice President, Global R&D, TCS and SPM, Pharmaceutical Packaging Systems. “With more complex drugs coming onto the market, quality in drug packaging is more essential than ever. It’s important for pharmaceutical and biotechnology manufacturers to seek a trusted partner to help design and manufacture sophisticated drug packaging and delivery systems that meet the needs of both the drug and the patient. We look forward to meeting with PDA attendees to discuss solutions for these current and future challenges for parenteral drug administration.”

Visitors to booth #405 can learn more about West’s industry-leading drug packaging and delivery system technologies at, including:

  • SmartDose® Electronic Wearable Injector
  • NovaPure® Plungers
  • Flip-Off® PlusRU Seals
  • FluroTec® Stoppers and Plungers. FluroTec® barrier film technologies is licensed to West from Daikyo Seiko, Ltd.

For more information on West products and services, please visit www.westpharma.com.

 

Exton Headquarters Achieves LEED Gold Certification

LEED logo

It’s official – the West Exton Headquarters building has been awarded Leadership in Energy and Environmental Design (LEED) Gold Certification from the US Green Building Council. LEED is an internationally recognized accreditation program that rewards best-in-class strategies and practices for the design, construction, operations and maintenance of environmentally friendly buildings. The Gold certification demonstrates to customers and the community that West is committed to its goals of sustainability.

“Constructing and operating the building and managing the project in accordance with LEED requirements ensures that we minimized the impact to the environment, incorporated design attributes to promote employee health  and maximized the energy efficiency of the building,” said Greg Warner, Director Operations Facilities. “Incorporating these LEED attributes results in a healthier environment, employee well-being and lower operating costs.”

The Exton headquarters was designed to maximize energy efficiency and minimize water use, and building materials were selected to minimize environmental impact through the use of recycled, natural and low-emitting products.

A smoke-free environment, the site design promotes the health and wellness of employees with natural lighting, bicycle storage and a fitness center. To help promote sustainability inside and out, materials such as the cork walls, rubber flooring and ceramic tiles were chosen, and native plants were used to eliminate the use of an irrigation system. Recycling in the cafeteria and throughout the building also helps West achieve and maintain this important accreditation.

West is committed to environmental sustainability and recognizes the importance of sustainability as part of our Company’s continued success. Congratulations to all those who helped to make this happen.

For more information about LEED Certification, visit http://www.usgbc.org/certification.

The Tech Group, a West Company, Receives Frost & Sullivan 2015 Manufacturing Leadership Award

West Pharmaceutical Services, Inc. (NYSE: WST) is pleased to announce that The Tech Group, West’s global contract manufacturing solutions provider, has received a 2015 Manufacturing Leadership Award in the Engineering and Production Technology Leadership category from Frost & Sullivan’s Manufacturing Leadership Council.

The award recognizes The Tech Group’s innovative process monitoring strategy, an initiative known as E2: Every Machine, Every Part. This enterprise-wide initiative reviews and improves control processes by integrating a state-of-the-art process monitoring system across 300 molding machines at all seven of The Tech Group manufacturing facilities throughout North America.

“We’re extremely honored to receive Frost & Sullivan’s award recognizing our significant investment and commitment to quality and process manufacturing excellence,” said Mike Treadaway, Tech Group President, PDS Contract Manufacturing, West Pharmaceutical Services. “As a key supplier of life-saving medical devices and critical components, we are constantly looking for ways to improve product quality. The Manufacturing Leadership Award is validation of the hard work and effort by the entire organization. The E2 initiative ensures our customers and their end users benefit from unmatched technical expertise and quality-driven manufacturing processes.”

The E2 initiative was launched as a pilot program in 2011 at The Tech Group’s Michigan plant. Its Process Excellence department tested manufacturing process discrepancies, including identifying sources of product variation and detecting product defects in real time. The Tech Group, heavily engaged in Six Sigma training since 2001, was able to leverage its experience in statistics and data collection, which was a critical step in the process. These findings led to new training programs, quality-focused infrastructure improvements and project management initiatives across West’s contract manufacturing facilities. Under the standardized process monitoring approach, it enhanced business processes by reducing manufacturing scrap, correcting up-time for post-injection molding assembly activities, and improving outgoing quality and on-time delivery to satisfy customers’ needs.

The Manufacturing Leadership Awards, now in their 11th year, honor manufacturing companies and individual leaders that are shaping the future of global manufacturing. Winning individuals and projects have demonstrated achievement in one of a wide range of categories. They are chosen by a panel of expert judges for results that enabled the manufacturers to set themselves apart from their competitors and that have delivered clear and compelling value, return on investment, and other tangible outcomes.

Frost & Sullivan will present the Manufacturing Leadership Award to The Tech Group at the 11th Annual Manufacturing Leadership Awards Gala on June 4, 2015, at the Omni La Costa Resort & Spa in Carlsbad, California.

 

 

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