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March 2010

MARCH 2010 ISSUE

Welcome to the CoolPack BioPharma Cold Chain Packaging & Distribution Newsletter.

The Newsletter aims to bring you updates in the industry on a monthly basis.

NEWS

NEWS:
- "Entropy Solutions announces the official launch of GREENBOX in Europe": Entropy Solutions has announced the official launch of GREENBOX in Europe: "As acceptance and adoption of GREENBOX has grown with the world's leading life science companies, access to a consistent global supply has become mandatory. With the launch of our European distribution, you are now guaranteed access to the same award-winning products and services that have been readily available in North America. As our business continues to expand globally, so too will our distribution."
- "Call for Papers 2010 PDA Europe Conference on Pharmaceutical Cold Chain Management": The 2010 PDA Europe Conference on Pharmaceutical Cold Chain Management, taking place on October 7-8th in Berlin, Germany, is calling for paper or poster abstract submissions. The deadline for presentations is May 1, 2010, and for poster abstracts is September 1, 2010. The application information can be found here.
- "Envirotainer Ownership Changes Hands": Pharmaceutical Commerce reports that "ACC Capital Partners, a leading Northern European buy-out firm, has executed a management buyout with Envirotainer". Read the full news article here.
- Cryopak Introduces New Products: Cryopak, part of the TCP Family of companies has introduced two new products: the TimeSaver Dry Ice shipping systems (pre-qualified polyurethane cooler with replaceable corrugated box, and foam plug), and the flexible ice pouch (pre-formed pouch with inner paper film to absorb condensation, and optional self adhesive strip).
- "Abbott Receives U.S. FDA Approval for Heat-Stable Tablets": PMPNews reports on the approval of a new formulation of the HIV drug Norvir which can be stored at room temperature, and does not require refrigeration. The new tablets were developed using Abbott's Meltrex technology, a proprietary melt-extrusion process which makes the drug more stable. Read the news here.
PRESS RELEASES:
- "Almac Launches New System for Monitoring Temperature-Controlled Clinical Trial Shipments": "Almac Clinical Services has launched stems, a new web-based shipping temperature electronic monitoring system for the pharmaceutical and biotech industries. Upon download, Almac's Shipping Temperature Electronic Monitoring System (stems) equips clinical supply professionals with immediate visibility over all crucial shipment temperature reports. This enables users to make instant decisions any time of day on their clinical supplies without the need for monitoring returns or faxing results. Stems reduces any quarantine time for clinical supplies at study sites, saving both time and money for a global clinical study." Read the full press release here.
- "Minnesota Thermal Science announces global partnership with SCA Cool Logistics": "Minnesota Thermal Science (MTS), an international provider of solutions for the safe transportation of temperature sensitive pharmaceutical, blood and biologic products, today announced its strategic partnership with European market-leader of temperature-controlled packaging, SCA Cool Logistics (Cool Logistics). The partnership will allow MTS and Cool Logistics to expand their operations globally, as well as to offer a complete range of products to all clients." Read the full press release here.

For more News, click here.

EVENTS

2010 PDA Pharmaceutical Cold Chain Management Conference & Training, (04-12-2010,Bethesda,United States)
- The conference, hosted by the PDA, will take place from 4/12/2010 through 4/15/2010. More information available here.
Global Regulations and Standards: Influences on Cold Chain Distribution, Packaging Testing and Transport Systems, (04-14-2010,Bethesda,United States )
- This event is a course from the PDA, which "will provide you with an introduction to Good Distribution Practices (GDPs) and includes the review of USP Chapter 1079 as well as cold chain regulations and documents from Europe, including the UK and Ireland." This course takes place from April 14-15 in Bethesda, Maryland. Click here for more information.
2010 PDA/FDA Pharmaceutical Supply Chain Workshop, (04-26-2010,Bethesda,United States)
- The conference, hosted by the PDA, will take place from 4/26/2010 through 4/28/2010, in Bethesda, Maryland. Click here for more information.
2010 IARW-WFLO Annual Convention & Expo, (04-29-2010,Scottsdale,United States)
- This convention, hosted by IARW & WFLO targets refrigerated warehousing and logistics professionals, and takes place in Scottsdale, Arizona from April 24 to 29, 2010. Click here for more information, and here to see relevant focus sessions.

Fore more Events, click here.

ARTICLES

"Can Your Cold Chain Hurt Your Company's Brand?": This article from Life Science Leader, discusses challenges in the distribution of temperature sensitive drugs. Among these, is the increase in scrutiny by regulatory bodies with regards to storage and transport of BioPharma products; it is mentioned that "in 2008, the FDA conducted inspections of drug warehouses" and that "forty-two inspections were conducted, and 16 inspections resulted in the issuance of FDA 483" for observations relating to temperature storage and transport. An increase in inquiries by regulators relating to ambient products is also noted. Key areas of the distribution stages are reviewed in detail, and best practices discussed. Temperature monitoring, including a survey conducted by Temptime to understand physician's concerns regarding breaks in the cold chain, and a desire for unit level tracking capabilities, are also mentioned. Click here for full article.
"Recognizing Pharma Cold Chain Excellence": This article by Kevin O'Donnell, from the Advanced Degrees column of contractpharma.com, summarizes the IQPC 2009 Cool Chain Excellence Awards winners and runners-up. Click here for full article.
"Abbott & Lilly Weigh-in on Use of Mean Kinetic Temperature (MKT) in Distribution": This posting from Kevin O'Donnell's Cooler Head Blog discusses an article from a May/June issue of Pharmaceutical Outsourcing Magazine which provides the most well defined, science based, guidance on the use of Mean Kinetic Temperature (MKT) to date. Read the full blog posting here, download the article here, and read the article at Pharmaceutical Outsourcing Magazine here.
"Looking at Air Cargo's Future Ability to Handle Biopharma Freight": This article from Pharmaceutical Commerce, discusses air shipment of biopharma products, and how they may be affected in the future by potential rising demand and shrinking capacity. Several action items and alternate options for industry to minimize the impact of such a scenario are provided. Read the full article here.
"DOT Proposes New Rules on Lithium Batteries": This article, from Pharma-Bio Transport, discusses proposed new regulations (Notice of Proposed Rule Making 75 FR 1302-NPRM: Transportation of Lithium Batteries) from the Department of Transportation (DOT) addressing the shipment of lithium batteries. Exceptions are still available in the proposed ruling which allow shipment of "extremely small lithium cells and batteries", which would not require shipment as Class 9 hazardous materials (i.e. lithium content at or less than 0.3 grams, or rating of 3.7 watt-hour or less). The final rule is targeted for publication December 2010. Read the full article here.
"Seeing More Green with a Greener Solution": This article from Pharma-Bio Transport discusses the total cost of ownership of cold chain shipping systems, and how reusable high performance solutions may have lower the total costs when compared to traditional single use systems, while providing environmental benefits. Read the full article here.
"Stowing Large Loads": This article from PMP-Digital discusses shipping systems, utilizing different technologies available for larger amounts of product, such as pallet quantities. Systems from Cold Chain Technologies, CSafe, Envirocooler, Entropy Solutions, Envirotainer, and Farrar Scientific are mentioned. Click here for full article.
"Schering-Plough Upgrades Clinical Trial Distribution": This article from PMP-Digital discusses a case study from Schering-Plough and their adoption of the Minnesota Thermal Sciences Credo system. Performance improvements, shipper selection, cost implications, and a return program with 84% return rate are discussed. Additionally, the use of Elpro Libero PDF temperature monitors programmed using product stability data, is also mentioned. Click here for full article.
"Sugar-coated vaccines can take the heat": This article from the Emerging Health Threats Forum discusses a recent "proof of concept study published this week in Science Translational Medicine opens the door for distribution of vaccines that can be stored and transported without a fridge. Experts say the work holds promise, but further testing is needed before the technology can be used to make vaccination cheaper and easier in the remotest parts of the developing world." Read the full article here.
Entropy Solutions partners with Cardinal Health with Pure Temp PCM Pouches - Video!: Entropy Solutions has partnered with Cardinal Health to use their Pure Temp PCM (Phase Change Material) for refrigerated applications, using Cardinal Health's standard insulated reusable totes. The video discusses this partnership, and provides a good explanation of how custom PCM's work in these applications. For video, see below, or click here.

For more Articles, click here.

WHITE PAPERS:

"The Critical Mission: Monitoring Critical Environments": This white paper from ShockWatch discusses the supply chain of temperature sensitive products, including pharmaceutical drugs, provides a summary of Regulatory Industry Citations by area (cold chain listed in top two), and solutions for monitoring critical environments. This document was originally printed in 2008. Click here for white paper.
"Industry Calls for Qualified Transport to Secure Supply Chain": This white paper from World Courier, briefly discusses the relationship between the pharmaceutical manufacturer and transportation providers, and the importance of understanding applicable regional Good Distribution Practices. Click here for white paper.

For more White Papers, click here.

JOBS

JOB POSTINGS:

NEW - Sensitech - Life Sciences Sales Rep. - MA, USA. View posting here.

For more job postings, click here.

LOOKING FOR EMPLOYMENT:

Cecilia Amador:
- Career Objective: Cold chain management specialist with experience in radio frequency identification (RFID) applications in search of a full time position within the perishables' industry. High interest in pursuing projects involving RFID deployments, temperature management, process traceability, or sensing technologies, where my strong leadership skills, analytical thinking, and research background can be applied.
- Download Resume

For more job seekers, click here.

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