FROM THE EDITOR
FDA Outlines Upcoming Regulatory Changes And Urges Industry To Be Proactive And Transparent
While reviewing upcoming changes heading industry’s way through regulatory legislations, such as the Food and Drug Administration Safety and Innovation Act (FDASIA) and the Drug Supply Chain Security Act (DSCSA), during her keynote session at Pack Expo 2014, Ricki Chase, director of investigations for the FDA’s Chicago office, urged the audience to not just focus on product integrity, but also personal and corporate integrity.
PHARMA MANUFACTURING INSIGHTS
Enhancing Isolator H2O2 Decontamination Processes
Hydrogen Peroxide (H2O2) decontamination is the most widely used and accepted form of decontamination in isolators.
Overcoming Challenges In Virus Removal
Biotechnological and biological therapeutic products are often manufactured using materials of animal or human origin, which carry a risk of being contaminated with either known or unknown viruses.
The Renaissance Of Sprinkle Formulations
By Sven Stegemann, PhD, Capsugel
About 25 years ago, multi-particulates were applied in pharmaceutical product development as so-called sprinkle formulations to overcome swallowing issues with larger oral dosage forms. After a growth in popularity in the 1990s, use of sprinkle formulations declined because of concerns about delivery and efficacy. These issues, which can easily be overcome, are addressed in this article.
Private Branding: How On-Demand Color Labeling Can Add Value To The Growing Generics Market
The generics market has taken off in recent years due to numerous patent expirations for brand-name companies. In light of this, pharmaceutical manufacturers, insurance companies and consumers, in search of significant cost savings, have turned towards the generics industry.
Single-Use Technology: The Trust Factor
What is missing today is trust. The axiom “trust but verify” is truer with single-use systems than in the past. The customer/supplier relationship required with single-use systems cannot be transactional, but must be a long term partnership for mutual success. This has to be built on a foundation of trust, and that is lacking today. For the end users, the implementation of single-use systems represents an outsourcing of critical operations, previously performed and controlled by their own people and quality management system.
PHARMA CONTRIBUTING EDITORS
The Challenge Of Managing Regulatory Submissions & Correspondence
Life science organizations produce large volumes of documents necessary for submitting applications to regulatory agencies. They need to have records of those documents as well as all related communications from sites around the world. This creates a situation that can be rather daunting.
Sponsors must first make sure all documents are going through the proper review and approval cycle and that controls are in place to meet regulatory requirements such as 21 CFR part 11. Once the documents are published and ready for submission to the regulatory agency, they are typically stored on a file share. Although that file share has access controls in place, it will not have granular-level access controls.
ISPE Releases Drug Shortages Prevention Plan At Annual Meeting
ISPE has released its Drug Shortages Prevention Plan at a media conference held during its annual meeting at Caesars Palace in Las Vegas. Present at the conference were new president and CEO John Bournas, strategic advisor John Berridge, and Drug Shortage Prevention Plan leaders Joe Famulare, Paul D'Eramo, Donna Gulbinski, and Sam Venugopal.
ISPE Set To Address Drug Shortages At Annual Meeting
Drug shortages continue to plague the pharmaceutical industry. According to a GAO report on shortages, dated February 2014, the number of shortages continues to increase in the U.S., as well as around the world. In 2007 there were 154 shortages, 114 new shortages and 40 ongoing from a prior year. In 2012, there were 456 shortages, 195 news ones and 261 ongoing. As of June 30, 2013, there were already 73 new shortages and 288 ongoing.
The public health importance of these shortages cannot be overemphasized. Shortage situations have included zinc for parenteral nutrition in neonates and premature infants, doxorubicin for ovarian and other cancers, and Propofol for anesthesia.
Clearly something needs to be done. “ISPE believes efforts to address this complex and multi-faceted problem of drug shortages requires close collaboration and clear communication between the pharma industry and global health authorities,” says Francois Sallans, VP and chief quality officer for Johnson & Johnson, and presenter at the 2014 ISPE-FDA CGMP Conference. “We believe The Drug Shortages Prevention Plan being assembled by ISPE will provide guidance to pharma and global health authorities to manage drug shortages more effectively. But more importantly we are looking into ways for the two groups to manage these shortages more proactively as well. That is an important component that we need to have in place in order to make these shortages rare, but short-lived.”
What Can You Learn From The Educational Planning Process Of BIO?
In my role as the 2015 co-chair of the BIO International’s educational planning committee, I am privy to what goes into creating one of our industry’s largest annual events. As many of you are involved in organizing your own customer educational programs (e.g., The Emerson Exchange) or have been asked to serve on an event planning committee, I thought a behind the scenes look into how BIO goes about the process would be helpful to your efforts. Here are some of the best business practices I have witnessed thus far.
Innovation In Clinical Trials: Is It Time To Change The Paradigm?
“People hate change. This is true in the life sciences industry and everywhere in the world. I think it’s a major, major problem.”
That statement, by Glen de Vries, president of Medidata, seems to sum up the challenge many have with trying to bring down the cost of clinical trials. To bring down costs we need to implement new, efficient, and available technologies. Unfortunately implementing new technologies involves change, which many people in this industry do not seem to want to embrace.
Hopefully, that attitude may soon be changing. One of the trends de Vries has seen in the past year is a focus on innovation originating at the executive level. More managers, especially those in the C-suite, are saying we need to figure out how to do things differently.
PHARMACEUTICAL ONLINE VIDEOS
It Might Look Like Just A Box - But It's A Lot More Than That
Envirotainer R&D continuously strives to improve reliability – it is core of all our operations. As a market leader, Envirotainer also takes on the role of driving innovation of existing products and solutions for the future.
Cold Chain Open House 2014 Webinar
Camille Madelon, Strategy and Business Development Director, states, “The industry needs innovation to stay competitive and relevant in the future – to meet new demands, for example due to changing regulations, emerging markets and new drug segments such as personalized medicine.”
Global Study Reveals The future Of Temperature Control Packaging
Sonoco ThermoSafe, a leading global provider of temperature assurance packaging, has revealed the results of its survey entitled “Assessing the Future of the Cold Chain Industry.” The survey highlights forward-looking trends in areas that significantly impact the cold chain industry – including environmental, trends, logistics and products and services. The survey’s 165 respondents spanned more than 20 countries and five continents.
Introduction to Multivariate Data Analysis
Brad Swarbrick, Vice President of Business Development at CAMO Software, gives a short introduction to multivariate data analysis, discusses some of its applications and how these powerful analytical tools are being used to improve products and manufacturing processes in a wide range of industries.
Introduction to Pharmaceutical Bag Filling and Sealing Equipment
Umbra bag filling and sealing machinery for all sorts of dry products in the food, pharmaceutical, chemical, and agricultural industries. A single Umbra packaging machine can fill bags of any material with varying fill weights and with different closure techniques, providing an extremely versatile solution to customers looking for high flexibility.
RoosterBio Selects BioLife Solutions CryoStor® To Commercialize Human Bone Marrow-Derived Stem Cells
BioLife Solutions, Inc. (NASDAQ: BLFS), a leading developer, manufacturer and marketer of proprietary clinical grade hypothermic storage and cryopreservation freeze media and precision thermal shipping products for cells and tissues ("BioLife" or the "Company"), announced today that Frederick, MD based RoosterBio, Inc., has adopted the Company's CryoStor clinical grade cryopreservation freeze media to commercialize RoosterBio's human bone marrow-derived, adult mesenchymal stem cell (hMSC) products.
Brookfield Engineering Laboratories, Inc. Brookfield is the world's leading manufacturer of viscometers and rheometers for the pharmaceutical industry. The rotational method of viscosity measurement enables complete flow curve characterization for pharmaceutical materials.
3M Purification (formerly CUNO) core filtration technologies address the most demanding applications in pharmaceutical processing for small molecule and active pharmaceutical ingredient (API) applications.
AT&T Inc. (NYSE:T) is a premier communications holding company and one of the most honored companies in the world. Its subsidiaries and affiliates – AT&T operating companies – are the providers of AT&T services in the United States and internationally. With a powerful array of network resources that includes the nation’s fastest and most reliable 4G LTE network, AT&T is a leading provider of wireless, Wi-Fi, high speed Internet, voice and cloud-based services.
Weiler Engineering, Inc.
Weiler Engineering is America's leading provider of aseptic Blow/Fill/Seal liquid packaging machines for pharmaceutical and healthcare applications
PHARMACEUTICAL ONLINE SUPPLEMENTS
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PHARMA EXPO 2014
As the highly anticipated November debut of Pharma EXPO approaches, we’ve developed this resource center for our readers to access the most relevant information about the event.
UPCOMING TRAINING COURSES
1pm-2:30pm EST, Online Training
1pm-2:30pm EST, Online Training
1pm-2:30pm EST, Online Training
1pm-2:30pm EST, Online Training
1pm-2:30pm EST, Online Training
LIFE SCIENCE WEBINARS
Aseptic Management of the Sterility Testing Process
Get the latest information on the aseptic management of the sterility testing process and find out some key insights into best practices.
Common Misconceptions in Freeze-Drying: Part Two
This is the second of two presentations addressing some of the most common misconceptions in freeze-drying (lyophilization) relating to formulations, process cycles, equipment and scale-up.
Overcoming Analytical Method Development Challenges: Analysis Of Nonclinical Dose Formulations From hERG Studies
This webinar is about overcoming analytical method development challenges with analysis of nonclinical dose formulations from hERG studies.
PHARMA INDUSTRY INTERVIEWS
A Game Changer In Disposable Fluid Connectors
At Pharma EXPO/Pack EXPO 2014 Ben Hund, U.S. Hygenic Segment Manager of Burkert Fluid Control Systems reveals the how Burkert's new disposable connector in 2015 will be a game changer in the industry.
Why Packaging Machine Flexibility Is So Important
Alexander Schmitz, GM U.S. Operations Confectionery and Food for Bosch Packaging Technology, took some time at PACK EXPO 2014 to discuss the biggest challenges food-packaging manufacturers are facing today.
The Impact Of X-Ray Inspection On Pharmaceutical Brands
At Pharma EXPO/Pack EXPO, Kevin Zarnick, sales manager, with Thermo Fisher Scientific, talks about the benefits of metal detectors, x-ray inspection systems, and checkweigher technologies for pharmaceutical brands.
Benefits, Risks Of Purchasing Used Process & Packaging Equipment
In an interview at Pack EXPO, Matt Hicks, COO with Federal Equipment, discusses the benefits and risks of choosing used process and packaging equipment rather than buying new.
11.25.14 -- The Potential For Implementing Quality By Design In Biomanufacturing
11/25/14 Pharmaceutical Online Newsletter
11.20.14 -- Standardized Extractables Testing Protocol For Single-Use Systems In Biomanufacturing
11/20/14 Pharmaceutical Online Newsletter
11.18.14 -- Product Safety In The Pharmaceutical Supply Chain; Dealing With Packaging Complexity
11/18/14 Pharmaceutical Online Newsletter
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