Using Spray Drying For Flu Vaccines: What Challenges Do We Need To Overcome?
When discussing the challenges of manufacturing flu vaccines, the conversation often shifts toward how manufacturers can meet the global demand each year. Currently there are some very innovative technologies aimed at addressing the challenge of manufacturing a larger supply of flu vaccines in a shorter amount of time, such as Novartis’ use of cell culture and Medicago and Fraunhofer’s use of tobacco plants. However, being able to deliver enough of a vaccine is only half the battle. It also needs to be delivered to its final destination within the appropriate temperature range. “It’s a huge misnomer for people who believe these technologies will unconstraint flu,” says Jim Robinson, VP of global technical operations, biological, and sterile products at Merck, who was involved in the manufacturing of billions of doses of flu vaccine prior to joining Merck. “The product still needs to get into a usable form and be delivered safely to the patient.”
Approaches To Best Practice MES Implementation
By Paul Murray, senior consultant, Enterprise System Partners
Traditionally, Manufacturing Execution Systems (MES) implementations, including Master Batch Records (MBR) modelling, have been executed by project teams located on site owing to the complex nature of the projects. However, as MES becomes better understood by project stakeholders, there are opportunities to consider other options. In this article, we examine the approaches available to pharmaceutical organizations to deliver a successful project.
Lo Jack SCI Partnership Integrates Cold Chain Solutions
Maintaining a product’s quality throughout shipment is a challenge in any industry, but delivering pharmaceuticals in the cold chain can be especially challenging because of the consequences related to temperature excursion. For this reason, Ted Wlazlowski, CEO and president of LoJack SCI, a company specializing in cargo and freight security, believes it’s necessary to offer clients both strategic planning and security for their cold chain shipments. And through their recent partnership with Modality, a supply chain environmental assessment and engineering solutions company, this is now possible.
Questions All Auditors Should Ask: The Use And Misuse Of Audit Checklists
By Laurie Meehan, Polaris Compliance Consultants, Inc.
There’s nothing wrong with using a good checklist, as long as you remember that there will always be something wrong with your checklist. It is simply not possible to develop a checklist that will get to the core of every problem, that will cover every scenario, or that will ever be any reasonable substitute for that all important question: "Why?" How can you develop the best checklists possible and avoid relying on them too heavily?
BDP Week Highlights The Importance Of Communication In BioPharma
At this year’s Biopharmaceutical Development and Production (BDP) Week, March 24-27 at the Hilton Bayfront Hotel, I attended several sessions that focused on how to strengthen the relationship between partners in the pharmaceutical industry. One overwhelming theme in each presentation was the importance of communicating effectively and clearly with everyone involved in a project.
PHARMA MANUFACTURING INSIGHTS
Hygienic Processing: Elimination Of Dead Space Volume
Hygienic processing places high demands on the reliability and cleanability of production facilities. These requirements are especially high in separation processes like filtration and chromatography and are significant in ensuring purity of media by maintaining sterile process conditions.
Benefits Of Using ELSD for the Analysis Of Traditional Chinese Medicines
Traditional Chinese medicines have played an important role in clinical therapy and have been attracting more and more attention for their complementary therapeutic effects to western medicines with low toxicity and few to no complications. With the use of traditional herbal medicines gaining popularity worldwide, the questions of purity and safety of these supplements or natural products have become a concern for public health authorities. The FDA, WHO, and the Chinese Pharmacopoeia have begun generating reliable and accurate analytical techniques to standardize quality control in manufacturing of these supplements to insure the correct identity, authenticity, and lot to lot consistency.
Adding Up The True Costs Of A False Positive Sterility Test
Use the following points to create your own list to examine just what aspects of ‘cost’ a false positive could be having on your business. They provide a base from which you can accurately determine the impact of false positives on your own production system. From this, you can begin to build a robust business case should you feel you need to mitigate risks for your own production process.
How Multi-Layer Tablets And Combination Products Are Reshaping Drug Development And Patient Care
The tablet technology that brought Aspirin, Lipitor and innumerable other drugs to billions of patients is evolving into multi-layer and combination products.
The Future Of The Pharmaceutical Supply Chain: 2014 Research Report
Implement tools, structures & strategies to create end-to-end visibility, manage global risk & complexity and create a more demand-driven supply chain.
Benefits Of Blister Packaging For Emerging Markets
Global research on the pharmaceutical packaging market indicates that blister packaging will continue its robust growth, projected through the remaining decade to trail bottling only slightly in market share. While mature markets, such as Europe and Asia, already accept blister packs as a preferred method – and with North America stepping up its blister usage – these markets, surprisingly, are not the driving force in blister’s growth. Instead, the increase is expected, in large part, to be spurred by the benefits blister packaging brings to emerging markets where product protection, patient compliance and the need for daily or weekly prescription dosage are often primary considerations. By Paul Dupont
The Role Of Quality Packaging To Our Industry
Packaging is an emerging science that has become a great contributor to the success of the pharmaceutical industry. It has become the core sector for marketing and the means by which manufacturers can differentiate their products from those of their competitors. By Chris Freeman and Dr. Claire Freeman, Brookfield
PHARMACEUTICAL ONLINE VIDEOS
Manufacturing And Packaging Of Custom Die Cut Disposable Medical Components
With 60 years of label printing and contract manufacturing experience, ATL specializes in the manufacturing and packaging of custom die cut disposable components for the medical industry including wound care, tight tolerance applications, island placement, and placebo and transdermal patches. An experienced engineering staff provides confidential product design assistance with written control plans, FMEA, and Systems/Production Validations.
Connected Sensors Unlock New Value In Transportation And Logistics
New applications for tracking of cargo and assets that our time and temperature sensitive of significant value.
Reusable Insulated Shippers With Single-Use Flexibility
Ideal for clinical trial shipments or other high value payloads.
AcuTemp Passive Shippers Video
When you need Peace of Mind™ that your temperature sensitive products will reach their destination at The Right Temperature®, rely on AcuTemp standard Passive Shippers.
AcuTemp Company Overview Video
The mission of AcuTemp Thermal Systems began taking shape over 25 years ago when Keith and Chris Meyer were working in a third-world country.
GP-CC Urges Pharma Companies To Form Coalition Against Chinese Counterfeit Drugs
The Global Piracy and Counterfeiting Consultants (GP-CC) offered its assistance to the U.S. Postal Service to stop delivery of Chinese counterfeit pharmaceutical products through U.S. mail. The group also urged U.S. consumers to be wary of purchasing pharmaceutical items online.
Terra Universal Terra Universal is the leading manufacturing expert in critical environment applications, with over 30 years of design and fabrication experience in clean room-related industries.
Parker domnick hunter Process Filtration
As the life science market continues to face challenges with the processing of high value and often fragile products, Parker domnick hunter brings fresh choice and new solutions to meet the filtration and processing needs of the industry.
Charles Ross and Son Company
Ross serves the requirements of the Pharmaceutical industry, in virtually every industrialized country around the world. We have the experience and production capacity that no other manufacturer of specialty mixing and blending equipment can match.
Fedegari Autoclavi SpA is the holding company of an Italian industrial group manufacturing customized machines, plants and the relevant components for the bio-/pharmaceutical and food industry worldwide. The know-how of the group lies in the field of sterile and clean processes and encompasses different technologies and products.
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BIOPHARMA EQUIPMENT AUCTION
Almost 700 lots from a Leading Global Research-Driven Company in Kenilworth, NJ, Bristol-Myers Squibb and Procter & Gamble.
Bidding opens April 14th Bidding closes April 16th
UPCOMING TRAINING COURSES
1pm-2:30pm EDT, Online Training
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LIFE SCIENCE WEBINARS
H.R. 3204 Drug Quality And Security Act
After so many years of struggling with how to comply with the California ePedigree requirement, we now need to know how to comply with the new federal requirement, H.R. 3204. This webinar will review DQSA requirements and timelines.
Adoption of Membrane Chromatography in the Vaccine Industry
This educational webinar will discuss a high throughput process development (HTPD) approach using Mustang® membrane to define the optimal operating conditions resulting in the best quality of the virus product and demonstrate the predictive power of this methodology as applied to the purification of influenza virus.
Guidelines For Good Density Measurement
The Good Density Measurement webinar provides you with a series of essential guidelines and helpful tips to help you achieve the most accurate results from your DMA.
04.15.14 -- Takeda And Lilly Hit With $9 Billion Penalty
04/15/14 Pharmaceutical Online Newsletter
04.10.14 -- FDA Awards Fast Track Status For Tetraphase Antibiotic, How Patent Translation Affects Your Bottom Line, And More
04/10/14 Pharmaceutical Online Newsletter
04.08.14 -- FDA Rebukes Efforts To Limit Access to Zohydro; GSK Halts Trial for Cancer Treatment
04/08/14 Pharmaceutical Online Newsletter
Big In Japan Series: Dr. Naveed Shams, President and CEO of Santen Inc.: “Globalization at a Japanese Pharmaceutical Leader”April 16, 2014
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