Mike Treadaway Completes London Marathon–Raising Funds and Awareness at the Same Time

Mike_marathon

A huge congratulations to our own Mike Treadaway, Vice President & General Manager, Contract Manufacturing, who finished the 35th annual London Marathon on April 18, 2016! Mike joined over 39,000 athletes who participated in this prestigious event—completing the race in 4 hours, 31 minutes. Mike combined his passion for running and goodwill by raising more than $3,000 for JDRF. JDRF (formerly known as the Juvenile Diabetes Research Foundation) is a major non-profit organization dedicated to funding type 1 diabetes research (T1D), with the vision of “a world without type 1 diabetes.”

With the completion of the London Marathon, Mike has now completed 5 of the 6 Abbott World Marathon Majors and is well on his way to achieving his goal of completing all 6 by running in the Tokyo Marathon in 2017. The Abbott World Marathon Majors consists of six of the largest and most renowned marathons in the world: Boston Marathon, Virgin Money London Marathon, BMW Berlin-Marathon, Bank of America Chicago Marathon, Tokyo Marathon, and TCS New York City Marathon. The organizers of these events are united in their effort to advance the sport, raise awareness of its elite athletes, and increase of the level of interest in elite racing among running enthusiasts.

The Tech Group, West’s Contract Manufacturing group, is a preferred supplier to several market leaders for continuous glucose monitoring systems and insulin pens that improve quality of life for patients living with diabetes. Mike’s commitment to giving back is a great example of West’s philanthropic culture.

 

Where Did that Particle Come from?

Print

Particles in drug products can come from many sources—extrinsic (from outside the process), intrinsic (from within the process) and even inherent (as part of the drug formulation)1. Therefore, performing a root cause analysis for particles is definitely neither an easy nor simple task. However, an analysis is necessary to prevent further occurrences of similar particle issues.

For injectable products, particle issues become even more crucial. This is because there is the risk that small particles in the drug product could be drawn into a syringe and subsequently injected into the patient. Depending on a number of factors2—including the nature of the particle, particle size and shape, and patient population—a contaminated injectable product has the potential to result in inflammation, allergic reactions, or blocked vessels, which can cause damage to tissues and organs and may even be life threatening  if vital organs are affected. When particles are found in a vial of injectable drug, it will be a race against time to determine the source of the particles, the extent of the issue, and the impact of the defect. The defective product will also need to be removed from the market.

Based upon our experience, West has developed the following questions to help a drug manufacturer deduce the source of the particle, better understand the extent of situation, and ultimately resolve the issue regarding the closure as a potential source of particulates.

  • What is the nature/identity of the particle?
  • Is it embedded or loose particle?
  • Where is the particle found?
  • What is the size and quantity of particle found?
  • What drug product is being contained?
  • What are the processing and parameters carried out on the components/product?
  • How are the incoming checks performed on the various components/raw materials?
  • How are the release testing/inspections performed on the finished product?
  • What is the acceptance/specification?
  • What are the test methods used?

West has developed a range of NovaPure® components, following Quality by Design (QbD) principles that help mitigate risk related to particulate. With our pharmaceutical customer’s goal in mind, Quality Target Product Profiles (QTPPs) have been defined for NovaPure® that include “Drug Product Compatibility – Fit for Use” with a Critical Quality Attribute (CQA) “Particle Characterization” and very low particle count limits are established for visible and sub-visible size ranges.

With quality built in from the start, NovaPure® components can help to reduce risk of defective drug products with its high quality standards and better consistency.

 

Author:

Boo Jia Min
Technical Support
JiaMin.Boo@westpharma.com

 

References:

  1. John G. Shabushnig, Ph.D. “Visible Particles: Regulatory and Compendial Requirements.” June 2014Presented at PDA Ireland Chapter Visual Inspection Seminar.
  2. Stephen E. Langille. “Particulate Matter in Injectable Drug Products” PDA J Pharm Sci and Tech 2013, 67. 186-200. Web. 21 July 2015.

 

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

Recent Changes to West’s Elastomer Formulation DMF

West has recently converted its Elastomer Formulation Drug Master Files (DMFs) to an electronic (eCTD) format. This change is the result of West’s direct collaboration with the U.S. Food and Drug Administration (FDA) and Health Canada to improve the agency review process of our customers’ pharmaceutical applications. Moving forward, West customers will notice a few changes in their Letters of Authorization/Access (LOAs). Since this is a conversion from paper to CTD format, the critical content of our regulatory files has not changed.

LOAs for FDA DMFs will reference new DMF numbers

West submitted new eCTD Elastomer Formulation DMFs to the Center for Drug Evaluation and Review (CDER) and the Center for Biologics Evaluation and Review (CBER), and a new, non-electronic CTD document to the Center for Devices and Radiologic  Health (CDRH).

All LOA requests for the FDA will now reference these new DMF numbers.

FDA Review Center Paper DMF No. New DMF No.
CBER DMF# 1998 STN 016769
CDER DMF# 1546 DMF 030048
CDRH MAF# 323 MAF 2694

Validity of historical FDA DMF LOAs

West customers currently using LOAs to reference our existing US DMFs (#1546, #1998, and #323) can continue to do so. These DMFs are still active files, they will be maintained for the foreseeable future, and the FDA still considers LOAs for these files to be valid. Customers can continue to reference historical LOAs to West’s DMFs and the FDA is authorized to review the information in support of their drug applications.

New LOA requests will only be issued to the new DMFs in eCTD format per West’s agreement with the FDA.

The Health Canada DMF number has not changed

The Formulation DMF (1976-001) held with Health Canada has also been converted to eCTD format; however Health Canada has opted to maintain the same file number. All LOAs for historical paper and electronic DMF are valid per West’s agreement with Health Canada.

For more information about West Regulatory Affairs and Support, please visit our website.

LoCastro Steve

Steve LoCastro
Director, Regulatory Affairs
Stephen.LoCastro@westpharma.com

ICH Q3D Elemental Impurities – What are the Requirements?

The International Conference on Harmonisation (ICH) has issued Guidelines for Elemental Impurities to limit patient exposure to potentially toxic elements above a specified limit during their course of treatment. Elemental impurities can be introduced, either intentionally or unintentionally, by excipients, manufacturing equipment, packaging (primary and secondary) and, of course, the drug substance itself. The ICH Q3D guideline identifies three key components to risk assess elemental impurities:

  1. Evaluation of toxicity data for potential elemental impurities.
  2. Establishment of Permitted Daily Exposure (PDE) values for each element.
  3. Development of controls for limiting inclusion of elemental impurities.

ICH Guidelines graphic

What are the elements included in the Guideline?

The elements evaluated are organized into several classes (listed below):

Class Elements Should Elements be included in Risk Assessments?
Class 1 As, Cd, Hg, and Pb Yes
Class 2A V, Mo, Se, and Co Yes
Class 2B Au, Tl, Pd, Pt, Ir, Os, Rh, Ag and Ru Yes, only if intentionally added
Class 3 Sb, Ba, Li, Cr, Cu, Sn, and Ni Depends on route of administration
Other Al, B, Fe, Zn, K, Ca, Na, Mn, Mg, and W No
  • Class 1 elemental impurities are significantly toxic across all routes of administration and require consideration during risk assessment across all potential elemental impurity sources.
  • Class 2A elemental impurities possess enough toxicity to require assessment across all potential sources and routes of administration due to their higher relative natural abundance (US Geological Survey, 2005).
  • Class 2B elemental impurities have more variable toxicities and require assessment across potential elemental impurity sources only if they are intentionally added to the processes used to generate the material under evaluation.
  • Class 3 elemental impurities have relatively low toxicity via the oral administration route but require consideration in the risk assessment for other routes of administration (e.g., inhalation and parenteral routes).
  • Other Elements: This category includes elemental impurities that have been evaluated, but for which a PDE has not been established due to their low inherent toxicity and are addressed by other guidelines and regional regulations.

How can I understand what impurities my container closure components are contributing to my Drug Product?

First, let’s understand a key difference between extractables, potential elemental leachables and elemental impurities.

Extractables, in this case, are elements which can leach from a component. These are determined based on components being extracted under exaggerated conditions (i.e. acid solutions) at high temperatures. Components are screened for elemental extractables using generally well characterized methods.  Result for extractable screening studies are reported as semi-quantitative until a method would be optimized and validated for specific elements. The purpose of extractable studies is to understand semi-quantitatively which elements can be extracted from the container closure system and use that knowledge to make decisions regarding relative risk. If there are elements of known concern at a given level and/or oxidation state, a method may need to be optimized because the screening method may or may not be suitable.

Potential Elemental Leachables are elements found in a solvent similar to the drug product and therefore can indicate the likelihood of occurrence in the final drug product.

Elemental Impurities are extractable elements that have been found in the final drug product under normal conditions of use. Elemental impurities are determined based on methods that are optimized for specific elements in drug product and validated.

To best evaluate your container closure system, West recommends the following approach:

  • Acquire an initial understanding of semi-quantitative extractable elements from primary container closure system components.
  • Consider the contribution of extractable element(s) to the final drug product elemental impurity profile. (Potential Elemental Leachables).
  • Conduct a drug product elemental impurity risk assessment to identify elements that may pose safety or quality concerns.
  • Link target elements back to the source(s) and origins to determine which components may need to be controlled.
  • Develop and validate methods for elemental targets in final drug product over the shelf life and individual components as necessary.
  • Ensure appropriate supplier agreements are in place that will notify you if there are any changes that could affect the elemental profile.

How can West help?

West can provide a variety of services to help aide in your overall risk assessments:

  • Extractable analysis – West Analytical Services has developed specific methodology to evaluate all elements included in the ICH Guideline.
  • Elemental leachable analysis – Once extractable elements have been assessed and targets confirmed, West Analytical Services has the capabilities to develop and validate specific methods to detect and quantitate elemental impurities in the drug product.
  • Overall Support – West can collaborate with you to support these assessments through setting up supplier/quality agreements, regulatory and technical support and availability of on-site auditing of our manufacturing sites.

What are the known implementation dates for ICH Q3D?

  • In Europe, the EMA has announced that new drug product applications will be required to comply with ICH Q3D beginning in June, 2016. Transition for marketed products is December 2017.
  • In the US, FDA has not yet set implementation dates for drug applications. However the USP has announced an implementation date of January 1, 2018 for General Chapters <232>, Elemental Impurities—Limits and <2232>, Elemental Contaminants in Dietary Supplements, in order to align with ICH Q3D.

 For more information, contact West Technical Customer Support.

Authors:

Lauren Orme, PMP
Senior Technical Account Specialist
Lauren.Orme@westpharma.com

Steve LoCastro
Director, Regulatory Affairs
Stephen.LoCastro@westpharma.com

 

Source: ICH Harmonized Guideline Guideline for Elemental Impurities Q3D, Dated 16 December 2014

West on the Road: Scottsdale, AZ – Part 3

WOTR1_screengrab1

Ever wondered what West’s cutting-edge product development facilities look like on the inside? Jeff Kyle, Sr. Director New Product Introduction, and Tom McLean, VP Delivery Systems R&D, take you behind the scenes of the Scottsdale, AZ plant.

In addition to exploring new products and custom packaging design, the Scottsdale plant manufactures the Crystal Zenith® Ready-to-Use Insert Needle Syringe System, and the SmartDose® electronic wearable injector. West recently expanded the Scottsdale facility to accommodate customer demand for the SmartDose electronic wearable injector, Kyle explains in this clip, including bringing it up to ISO 7 cleanroom standards. That certification – and the tight layout of the assembly floor – helps employees create the systems more efficiently.

Moving to the lab, Jessica Wentzel, Microbiology Lab Manager, demonstrates the rigorous testing that incoming raw materials and Daikyo Crystal Zenith® cyclic olefin polymer components undergo, from a microorganism and endotoxin standpoint.

As McLean points out, West’s state-of-the-art technology and complex production protocols are put in place for one thing: Enriching patient safety. It’s this element of creating pharmaceutical integrated containment and delivery systems for injectable medicines that inspires pride among West employees.

 

 

 

 

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

SmartDose® is a registered trademark of Medimop Medical Projects Ltd., a subsidiary of West Pharmaceutical Services, Inc. West seeks partners for its SmartDose® injector technology platform. This platform is intended to be used as an integrated system with drug filling and final assembly completed by the pharmaceutical/biotechnology company.

West Attends Girls Exploring Tomorrow’s Technology Event

GETT Expo

On March 12, 2016, West sponsored the Girls Exploring Tomorrow’s Technology (GETT) Event at West Chester East High School in Pennsylvania. More than 700 elementary, middle and high school girls in grades 5 through 10 attended the event, which features successful women in science, technology, engineering and math (STEM). Attendees learn the facts about how STEM careers can be fulfilling, fun and rewarding personally, professionally and financially.

West was a gateway sponsor of the event and thanks to the joint cooperation of the H.O. West Foundation, West without Borders® committee and the WIN (Women Investing and Networking) Group, several West women were able to attend the event, including Sr. Vice President and Chief Commercial Officer, Karen Flynn, who assisted presenters from Philadelphia-based start-up company Integral Molecular as they taught students about the importance of iron in the body and sources of iron in food.

“The girls did a hands-on exercise in which they crushed up cereal fortified with iron and then used magnets to actually ‘pull’ the iron from the cereal so that you could visually see it,” said Karen.

At the booth, West’s Monica Habash, Packaging Engineer; Than Quynh Le, Project Specialist, Technical Customer Support; and Jessica Bohn and Jenna Lockyer of the West Sales team taught the students Poiseuille’s Law, which focuses on how a liquid’s viscosity and the diameter of a syringe can affect the pressure needed to push a plunger rod down on a syringe. The experiment, which was designed in collaboration with West Analytical Labs, used corn syrup and water to highlight the different pressure needed to administer the liquid.

“The girls were very engaged in the experiment. It gave them a chance to feel the difference in viscosity and how it applied to Poiseuille’s Law in real life. They could easily see how much thought, science and engineering went into the design of West’s delivery systems,” said Jenna.

A second experiment demonstrated the difficulty some people may have – including those with dexterity issues such as Rheumatoid Arthritis – in completing a self-injection. The students were asked to put on a thick leather glove and then pick up a syringe. The West WIN volunteers then demonstrated products including the SmartDose® and SelfDose® injectors that are designed to fit the needs of customers and patients.

“The event is a great place for students to get a better understanding of the different types of STEM careers available to them, including designing syringes and delivery systems for patients,” said Jessica. “We use STEM every day, even in sales roles. Just because you enjoy science doesn’t mean your career will take place in a lab.”

In addition, Laura Pitt, Manager, Community Affairs, and Janet Cooper, Executive Assistant, helped the girls learn about West’s philanthropic efforts through West without Borders and continuing support for Canine Partners for Life.

“Even though we are busy to manufacturing high quality products for our customers, West always makes time to give back to the community,” said Laura. “For example, we support Canine Partners for Life, which raises and trains service dogs to assist individuals who have a wide range of physical and cognitive disabilities.”

The WIN volunteers are already excited to attend the event next year.

“We’ll definitely be back,” said Jenna. “We’re already starting to talk about how to engage the girls and show them how to get the most out of a career in STEM.”

 

 

SmartDose®, SelfDose® and West Without Borders® are registered trademarks of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.

 

 

Carnival Festivities Help Raise Funds for Animals in Aachen, Germany

Carnival

The carnival season, also referred to as the “Fifth Season,” is one the most celebrated traditions in the Rhineland of Germany where West’s German plant and office sites are located. Carnival festivities took place 40 days before Easter, starting on November 11 at 11 a.m. and ending on Ash Wednesday, the beginning of Lent. A group of female employees at the European Headquarters in Eschweiler turned women’s carnival on “Fat Thursday” (February 4), into a fundraising campaign and raised 211,11€ in the process. The money has been donated to a local animal shelter in Aachen.

Disguised with masks or costumes and equipped with scissors, the women sold doughnuts and cut off the ties of their fellow male colleagues for a monetary donation. Most of the gentlemen came prepared to sacrifice their ties for a good cause. At the end of the day the “trophies” were exhibited and employees were able to vote the most unique tie in terms of design.

Thanks to the West team in Germany who helped make this campaign a fun and successful way to give back to the community.

 

Nadine Gerstler
Communications Specialist
Nadine.Gerstler@westpharma.com

 

 

 

 

 

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