Charity Under the Big Top – West’s Kinston Team Delivers With Circus Theme

Come one, come all to the 2014 West without Borders campaign! From preliminary planning to the final one-ring circus, the 2014 West without Borders campaign in Kinston, N.C., was a whole lot of clowning around in the name of a good cause. This year, Kinston team members supported three charities: Relay for Life Kids’ Walk, Kid’s Cafe and Shriners’ Hospital for Children’s Transportation Fund.

The fun began with a raffle for a massive Valentine’s Day basket of goodies, and rolled on when the charities were selected.

Kinston 1

As a sponsor of Relay for Life’s Lenoir County Kid’s Walk, West team members helped to place a strong focus on the many children diagnosed with cancer each year. The Kid’s Cafe Afterschool Program provides nutritional meals as well as mentoring, tutoring, arts and crafts, and physical activities to needy children ages 5-14 in Lenoir County. Team members continue to collect books to help enrich the program’s sparse library.

In supporting the Transportation Fund for Shriners’ Children’s Hospital, the group helped provide transportation through the “Roadrunner” program, which zips patients from eastern North Carolina to the hospital in Greenville, S.C. More than 35 drivers donate their free time to transport patients and their parents safely.

With a goal to raise $14,000 this year, the games began with meetings, celebrations, clowning around and a circus-themed picnic with prizes, food and fun for adults and children alike. Thanks to the generosity of the team members, more than $20,000 was raised!

Kinston 2

To all those who offered time, donations and fun to this wonderful campaign, thank you!

West without Borders is not affiliated with Doctors Without Borders®, which is a registered service mark of Bureau International de Médecins Sans Frontières.

West Receives Johnson & Johnson Supplier Award

West Pharmaceutical Services team members performed especially well this year for the Janssen Supply Chain Global Procurement Organization (a part of the Johnson & Johnson group of companies), which recently presented the team with the bronze Supplier Award. The award was presented during a ceremony at the J&J facility in Turnhout, Belgium, on May 7.

“West is proud and happy to have earned the award,” said Patrick Radermacher, Area Sales Manager. “A big ‘thank you’ goes out to all of our colleagues who have been part of this process directly and indirectly.”

The award is presented to suppliers who have performed particularly well during the previous year. The ceremony also allows J&J to connect with its suppliers and discover achievements and expectations in a relaxed atmosphere.

Congratulations to all those whose diligent work helped West achieve this award!

Janssen

From left to right: West’s Heino Lennartz and Patrick Radermacher, Joe Agresta (VP Global Procurement, J&J), West’s Marc Klinkenberg, and Vincent Godin (Sr. Manager Global Procurement, J&J)

Have You Seen West’s Redesigned Website?

Westpharma.com has been upgraded!  The new, mobile-friendly site offers easier navigation, intuitive design and  enhanced searchability. The new site is mobile-friendly, and can be easily viewed and navigated from phones and tablets.

  • View the new design here.
  • To see our By Your Side video, click here.
  • To select a color combination for your Flip-Off® seals, click here.
  • For information on our quality-by-design NovaPure® components, click here.
  • Find out how the SmartDose® electronic wearable injector solves drug delivery challenges, click here.
  • Are you interested in a career at West? Click here.

The redesign incorporates West’s vision – By your side for a healthier world. These simple words carry a powerful message. By working side-by-side with our customers, West can help deliver life-saving therapies safely and effectively to patients.

The website redesign is just the first step in bolstering our online presence. Watch for further updates in the coming months and check back often for blog, newsletter and article updates!

 

Influence of Primary Components on Parenteral Delivery Systems, Biologic Therapies and Patient Outcome

The following is an excerpt of an article that appears in the Summer 2014 edition (Vol. 6, Issue 2) of International Pharmaceutical Industry magazine.  To read the complete article, which begins on page 92 of the issue, visit: http://issuu.com/mark123/docs/ipi_-_volume_6_issue_2_june_2014

Development of therapeutic proteins has been on the rise for a variety of disease conditions. The administration of parenteral biologics relies on interconnected attributes associated with compatibility of delivery components to the safety and efficacy of the final product. It is essential to characterise individual components in contact with a biologic to understand the risks to the delivery system as a whole and the effect on patient outcome. Selecting an appropriate delivery system for these therapies is critically important. The quality of the components within a delivery system also has a significant impact on the development efficiency and the time to market. There are unique regulatory expectations as well as physical and chemical aspects that need to be considered when choosing components for a delivery system. Adequate information on user needs is necessary to design a delivery device suitable for intended use. Quality considerations are important throughout each phase of the pharmaceutical lifecycle to assure fitness for intended use relevant to patients. Alignment of the delivery device with the biologic manufacture, storage and distribution processes is a key element for bringing a product to market.

By Diane Paskiet
Director, Scientific Affairs

 

Evaluation and Comparison of Protein Adsorption and Cellular Activities in Cyclic Olefin Polymer Container Systems for Drug Delivery and Cell-Based Applications

Manfai Lee, PhD1, George M Rodgers, MD, PhD1, Randy Y Adachi, PhD2

1Division of Hematology and Hematologic Malignancies, University of Utah Health Sciences Center, Salt Lake City, UT   2West Pharmaceutical Services, Inc., Scottsdale, AZ

Purpose

The purpose of this study was to evaluate protein adsorption to Daikyo Crystal Zenith® (CZ; cyclic olefin polymer) plastic vials and to compare the results with commercially available glass and polypropylene vials; to measure protein activity recovered after storage in vials; and to evaluate cell viability cultured in CZ container systems. This information will be useful to assess the suitability of CZ containers in protein-based and cell-based applications.

Methods

ADAMTS13 (20μg/mL), as a labile model protein, was stored in 1) 0.5mL CZ vials, 2) 0.3mL borosilicate glass vials, 3) 0.5mL polypropylene (PP) cryogenic vials, 4) 0.5 mL PP low-retention microcentrifuge tubes, and 5) 0.5 mL PP traditional microcentrifuge tubes at -70°C. After one and four months of storage, protein recovery was quantified using an ELISA assay. To measure ADAMTS13 enzymatic activity, 25μL of vWF (200μg/mL) (a specific substrate for ADAMTS13) was mixed with 25μL of ADAMTS13 (20μg/mL) and incubated at 37°C for two hours. The cleavage of vWF by ADAMTS13 was analyzed by SDS-PAGE. The adsorption of ADAMTS13 to the storage vials was measured by staining with either Coomassie Brilliant Blue G-250 or colloidal gold. Human umbilical vein endothelial cells (HUVECs) and LN229 glioblastoma cells were cultured in CZ containers. Cell proliferation, viability, and migration were studied and compared with commonly used polystyrene (PS) containers using MTT, ELISA, and scratch wound assays.

Results

The amount of ADAMTS13 recovered from CZ vials was comparable to that from PP vials, and was significantly higher (~10%) than the recovery from glass vials. These results were in good agreement with protein staining, which indicated more ADAMTS13 adhered to the surface of glass vials than to plastic vials. Enzymatic studies indicated that ADAMTS13 stored in CZ containers remained active after four months of storage. Cells cultured in CZ containers exhibited 36% greater rate of proliferation and an increase in cell-migration as compared to the PS container. Conclusion: CZ plastic container systems made of cyclic olefin polymer are suitable for storing protein-based drugs and can be used for culturing and growing live cells.

See the full scientific poster here: AAPS NBC Poster Final 050514.pdfAAPS NBC Poster Final 050514.pdf

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

Causes of Coring and Fragmentation in the Field

One of the challenges a drug manufacturer faces is controlling the drug product at the point-of-use in a hospital or clinical environment.  Often the method of vial access is variable, leading to an increased risk of harmful patient outcomes such as stopper cores or fragments entering into the drug product, which can contribute to cardiovascular events.  There are a number of causes that contribute to stopper coring and fragmentation in the field that depend primarily on the technique of the practitioner and the properties of the elastomeric closure.

Causes of Coring or Fragmentation (Technique):

  • Needle type – it has been observed that blunt needle tips have a much greater tendency to produce fragmentation than sharp beveled needles.
  • Needle gauge – needles larger than a 21-gauge tend to promote fragmentation.
  • Needle siliconization – needles with low or inconsistent siliconization cause increased coring and fragmentation.
  • Needle reuse – reuse will dull a needle, remove silicone and increase the chance of coring and fragmentation.
  • Force of puncture – lower needle insertion forces reduce the tendency for coring.
  • Angle of puncture – needle insertion at a 45° angle to the plane of the stopper reduces the likelihood of coring.
  • Number of punctures – multiple stopper punctures greatly increase the chance of coring.
  • Incorrect use – using a spike on a stopper design that was not intended to receive a spike will produce fragments.

Causes of Coring or Fragmentation (Closure Properties):

  • Elastomer formulation – natural rubber and synthetic isoprene formulations typically have more robust functional properties than butyl formulations and show reduced coring because of their increased tensile strength.
  • Configuration – the stopper diaphragm thickness typically plays a role in coring.  Generally, thinner stopper diaphragms reduce the likelihood of coring.
  • Siliconization of the closure – unsiliconized closures may see increased coring results.
  • Closure processing – excessive processing of closures, particularly high gamma irradiation, may degrade the elastomer and result in increased coring.

To reduce the possibility of coring, West recommends increased field education on proper needle/spike usage and selection.  Additionally, the drug manufacturer can help prevent coring through the proper selection of elastomer formulation and design for end use.  For known multidose applications, synthetic isoprenes and specific low-coring stopper designs are available.  Vial adapters are another way for the drug manufacture to ensure normalized vial access in the field and multiple dose withdrawal with a single stopper puncture.  Finally, understanding the impact of processing on the physical properties of the elastomeric formulation is an essential aspect for reduced coring. Please contact your West Technical Account Specialist to discuss some low-coring stopper options.

Author:

Patrick Gallagher
Technical Account Specialist
Patrick.Gallagher@westpharma.com

Comparison of the Stability of Four Biologics Stored in Prefillable Syringes Made of Glass or Plastic

By Lloyd Waxman and Vinod Vilivalam

The use of proteins as therapeutics has focused attention on the need to maintain the stability of these labile molecules during both storage and shipment. The trend in the pharmaceutical industry has been to package therapeutic proteins in prefillable syringes made of glass. However, some biologics are not stable in glass syringes due to sensitivity to silicone oil and adhesives used in their manufacture and to tungsten oxides generated during needle placement. Syringes made from the plastic Daikyo Crystal Zenith® (CZ) cyclic olefin polymer, in addition to being break resistant, have none of these issues. However, heretofore there have been no published studies that have compared the stability of biologics in syringes made from glass with ready to fill E-beam processed CZ syringes.

To investigate the stability of biologics maintained in 1mL long syringes made of CZ, four biotherapeutic proteins were stored at 5 and 25°C up to one year; two of these were also maintained at 40°C. The same proteins were also stored in syringes made of glass. Several methods were used to monitor aggregation and degradation of the test molecules including turbidity, size exclusion chromatography (SE-HPLC), reverse-phase chromatography (RP-HPLC), ion-exchange chromatography (IEX), and gel electrophoresis. This study focused on the data from the one year time point.

Conclusions

This study compared the stability of four structurally diverse biomolecules stored in 1mL long syringes made of glass or CZ for 1 year. All four proteins were stable at 5°C in syringes made of glass or E-beam processed CZ. Proteins A and B were also stable in both glass and CZ at 25°C. At 40°C, there was more aggregation in syringes made of glass than plastic. Proteins C and D aggregated at 25°C in both glass and CZ syringes. Turbidity was higher in CZ syringes, but recovery of soluble protein from syringes made of glass or CZ was the same. Using additional analytical techniques including IEX and electrophoresis, no significant differences were found whether the proteins were stored in CZ or glass syringes.

In a parallel study, autoclaved CZ syringes were compared with E-beam sterilized CZ syringes. There was no impact on protein stability at either 5°C or 25°C (data not shown). As a plastic, CZ has several advantages over glass including the ability to be molded into other syringe formats or cartridges for on-body injectors. A head-to-head comparison between glass and CZ can best determine the most suitable container closure system for a biotherapeutic protein.

To read the full scientific poster, click here: West_Handout8408_print.pdfWest_Handout8408_print.pdf

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

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