FEATURE ARTICLES

  • Yield, Creep And Recovery - Why Are They Important?
    Yield, Creep And Recovery - Why Are They Important?

    Material flow behavior may include the phenomenon called “creep” which applies to various liquids and semi-solids, like gels and lotions that continue to move slightly even after placement on the skin. R&D’s intent when formulating the substance is to minimize movement because the medicinal effect is best accomplished by keeping the material in the original position where it is applied. By Robert G. McGregor, General Manager – Global Marketing, Brookfield Engineering Laboratories, Inc.

  • Influence Of Silanol Content, Humidity And Temperature On Efficacy Of A Silica Based Carrier
    Influence Of Silanol Content, Humidity And Temperature On Efficacy Of A Silica Based Carrier

    Recently, silica based carriers have been widely used for the adsorption of oily and lipid based formulations. Using silica as adsorbent, liquid self emulsifying drug delivery systems could be formulated in tablet or capsule oral dosage form. For this application, an ideal carrier is one which possesses high adsorption capacity and immediate desorption or release at desired site. Three different types of carriers like Granulated fumed silica (GFS) Syloid® XDP-Mesoporous silica gel (MSG) and Magnesium aluminum silicate (MAS) were selected for this study. By Yogesh Choudhari, Upendra Reddy, and Fred Monsuur, Grace

  • Using Spray Drying For Flu Vaccines: What Challenges Do We Need To Overcome?
    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
    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
    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.

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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.

  • 2014 1st Quarter Supply Chain ISAC Report Of Cargo Theft Activity

    In tracking Cargo Theft activity by state as reported to the SC-ISAC in the first quarter of 2014, we see Texas continuing it strong showing by having more incidents than California for the second quarter in a row. The four other states with significant incidents are Georgia, Illinois, Florida and New Jersey.

  • 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

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  • Parker domnick hunter Process Filtration
    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.

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    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.

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    Fedegari Group

    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

Building Accountability on Your Clinical Teams

April 29, 2014
1pm-2:30pm EDT, Online Training

Root Cause Analysis for Clinical Research Professionals

May 5, 2014
1pm-3pm EDT, Online Training
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LIFE SCIENCE WEBINARS

  • H.R. 3204 Drug Quality And Security Act
    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.

     

  • PAT-Enabled Process Optimization & Control

    PAT is a risk-based strategy for designing, analyzing and controlling manufacturing processes. The Critical Process Parameters (CPPs) are identified in line with the definition of the Critical Quality Attributes (CQAs) of intermediates or final products. PAT offers a number of tools for measuring and controlling these CPPs.
    Sartorius has the right choice of solutions you need: discover our world of Synchronized PAT Solutions.

  • Adoption of Membrane Chromatography in the Vaccine Industry
    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.

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 PHARMACEUTICAL EVENTS

Biologics World Korea 2014

April 22 - 24, 2014
Seoul

Drug Discovery Chemistry 2014

April 23 - 25, 2014
San Diego, CA

15th Annual Computer and Software Validation

April 23 - 25, 2014
San Diego, CA

China: Regulatory Affairs for Pharmaceuticals

April 24 - 25, 2014
Radisson Blu Edwardian Grafton, London
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