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BIOANALYSIS FEATURED ARTICLES

Applying QRM To The Change Control Process
Applying QRM To The Change Control Process

Since the publication of ICH Q9: Quality Risk Management in 2005 (1), there has been much written about the application of risk management to the production process, product development and validation (2–5). Relatively little has been published about its application to some of production’s supporting processes that comprise an important part of the pharmaceutical quality system (PQS).

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BIOANALYSIS FEATURED WHITE PAPERS AND CASE STUDIES

  • Managing Risk In Biomanufacturing
    Managing Risk In Biomanufacturing

    Commercial, manufacturing, and supply aspects in the biopharmaceutical industry can all be managed in order to mitigate risk. This white paper focuses on how a structured and transparent risk management process can be an ideal way to align the needs of patients with drug manufacturers and their suppliers, regulators, investors, and employees. Read on to learn more about guarding commercial interests, building and managing manufacturing capacity, and preventing supply disruption, and how these things can impact managing risk in biomanufacturing.

  • Closed System Filling Technology: A New Paradigm
    Closed System Filling Technology: A New Paradigm

    “Closed system filling” is a new set of processing controls for a sterile filling process that eliminates potential microbiological contamination from environmental and operator sources through the use of closed systems. 

  • 6 Guidelines To Follow When Developing Combination Products
    6 Guidelines To Follow When Developing Combination Products

    While the development of a combination product comes with significant patient benefits through technology and molecule innovation, that reward can be offset by the range of regulatory complexity and uncertainty encountered with bringing a product to market, in addition to any post-marketing activities.

  • Wireless Dose-Compliance Monitoring In Drug-Delivery Devices
    Wireless Dose-Compliance Monitoring In Drug-Delivery Devices

    Incorporating wireless technology into medical devices is about more than just keeping up with the hottest technology trends; the benefits are real and significant, especially with regard to monitoring and encouraging dose compliance in the pharmaceutical and medical realm. Prior to embarking on the development of a wireless-enabled drug-delivery device, however, it is crucial to know what, specifically, the benefits are, and exactly what kinds of challenges and design considerations must be taken into account.

  • A Case for Co-Sourcing Laboratory Services
    A Case for Co-Sourcing Laboratory Services

    Many industry observers believe the need for responsive, collaborative, and tech-savvy partnerships is paramount in the new emerging business environment. Success or failure in this environment will be defined by operational agility to research, adapt, produce, and deliver products rapidly under fluctuating market conditions. 

  • Managing Laboratory Consumables
    Managing Laboratory Consumables

    Since All I Really Need to Know I Learned in Kindergarten first appeared in 1988, its simple, profound wisdom has inspired the world. Among its easily digested messages are a few gems that research scientists would do well to employ in their labs every day: Share everything, Play fair, Put things back where you found them, CLEAN UP YOUR OWN MESS, Don't take things that aren't yours.

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BIOANALYSIS PRODUCTS

NDA Approval And Post Approval Services NDA Approval And Post Approval Services

From 2006 through 2015, Patheon helped clients earn 92 NDA approvals. That’s  twice as many as any other CMO. Success brings more success at this stage. That’s because depth of experience, reliability of quality and refinement of processes are all important in the final push for regulatory approval and making the transition to commercial manufacturing.

Automated Incubator for Assays: BioSpa 8 Automated Incubator for Assays: BioSpa 8

BioSpa 8 Automated Incubator links BioTek readers or imagers together with washers and dispensers for full workflow automation of up to 8 microplates. Real time control and continuous temperature, CO2/O2 and humidity level monitoring, along with lid handling ensure an ideal environment for cell cultures during all experiment stages, with minimal manual intervention. BioSpa’s software, which features customizable text or email notifications and alerts, also relieves the need for onsite monitoring. The software’s session timelines and environmental reports allow quick scrutiny of the process and system status. BioSpa 8 automates assay workflows by repeated manipulation and storage of microplates containing live cells or temperature sensitive reagents. Link one washer or dispenser, one plate reader or imager, or one of each for start-to-finish workflow automation. BioSpa 8 is ideal for efficient automation of short or long-term cell based and other temperature, gas and humidity sensitive processes.

Logistics Audit/Assessment & Engineering Solution Services

Modality Solutions provides services such as: cGMP readiness assessments, product characterization and stability studies for distribution, controlled-environment logistics process validation, quality management systems and change control, and thermal packaging design and qualification.

PerFix-nc Assay Kit: Flow Cytometric Analysis

An innovative tool for flow cytometric analysis of multiple intracellular epitopes, or both multiple intracellular and cell surface markers, by fixation, permeabilization and staining of human leucocytes from peripheral whole blood, together with erythrocyte lysis, all without centrifugation!

PerFix EXPOSE Cell Signaling Kit

The PerFix EXPOSE Kit (Phospho-Epitopes Exposure kit) is a Fast & Easy Procedure for Cell Signaling. It consists of three ready-touse reagents, and one solution requiring a 20-fold dilution before use.

Water-For-Injection Quality Water (WFI) Water-For-Injection Quality Water (WFI)

Water for Injection (WFI) Quality Water is the most suitable water available for producing cell culture media, reconstitution of biochemical reagents, and as a final rinse water for critical applications. WFI Quality Water meets both EP and USP grade specifications and is 0.1µm sterile filtered at time of fill.

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BIOANALYSIS MEDIA

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.

 

Easily Switch Between Washing And Filtration With An Interchangeable Microplate Washer

The Hydroflex microplate washer is a modular and upgradeable platform is ideal for a wide range of cell-, enzyme- and DNA-based applications in academia, biotech, pharma and clinical diagnostics, reflecting over 30 years of Tecan expertise in advanced liquid handling.

How The Infinite M100® PRO Uses Monochromator Innovations For Microplate Reading

Tecan's Inifinte M1000 PRO microplate reader has Quad4 Monochromators technology that uses excitation monochromators to enable good performance over the whole wavelength spectrum.

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BIOANALYSIS INDUSTRY NEWS

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