Business Process Management
PRODUCTS
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We support you in the process of optimally implementing complex Manufacturing Execution Systems. In addition to the creation of Master Batch Records (MBRs) and Electronic Batch Recording (EBR), including classic data acquisition and preparation, as well as all other processes that have immediate effects on the manufacturing process.
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Standalone, turnkey, process ready cGMP modular cleanrooms
Germfree cGMP modular cleanrooms are a platform solution that unlock standalone manufacturing capacity for a variety of applications. Serving processes from cell therapy to sterile fill-finish manufacturing cGMP modular facilities offer unmatched finishes, layout flexibility, controls, timeline assurance, and cost benefits for the biopharmaceutical industry. This is why Germfree has been chosen by 12 of the top 20 biopharmaceutical companies as their modular cleanroom providers.
Modular cleanrooms highlights: Biopharma, International building codes, IBC, NFPA, ISO. BSL-2 BMBL, FDA, EMA, cGMP compliant
Applications: Aseptic Filling, Cell Therapy, Gene Therapy, Viral Vector, Plasmids
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In cell and gene therapies, the process is the product. We have deep expertise developing and scaling processes for cell therapies and viral vectors, including lentiviral vectors and AAV.
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Guide operators through dynamic workflows from equipment startup to maintenance.
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The most widely trusted solution for clinical trial disclosure management
Managing clinical trial disclosures can be tedious and error-prone, opening the door to noncompliance. TrialScope Disclose provides a better way.
Our centralized platform automates data entry and reporting for Clinicaltrials.gov, CTIS, and more. This reduces manual effort so you can focus on bringing new treatments to patients, not paperwork.
WHITE PAPERS AND CASE STUDIES
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Case Study: Connexin Is Taking The UK's 'Smart Cities' To The Next Level
With Skedulo, Connexin is streamlining processes via automation, increasing connectedness between their office & field teams, and elevating their customer experience.
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Leading European CDMO For Drug Product Manufacturing
As timelines tighten and regulatory demands grow, discover how a European CDMO delivers integrated solutions from aseptic fill and finish to packaging and release.
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Material Selection For Medical Device Manufacturability
Choosing the right material in the earliest stages of research & development can make all the difference in beating your competitors to market and avoid increased project costs, development delays and manufacturing setbacks.
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Developing And Validating Clinical Receptor Occupancy Pharmacodynamic Biomarker Assays
Receptor occupancy (RO) assays assess drug-target engagement and support PK/PD modeling. Accurate RO requires customized assays using stabilized blood to monitor CD6 modulation in autoimmune therapy.
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From Regulators To PUPSIT: Notes On Annex 1 Revision Implementation
Kevin Smyth, a biochemical engineer with 30 years of experience in the pharmaceutical industry, offers insights and expertise in working with firms to understand what regulators seek to meet new standards.
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A Unified Approach to Clinical Trials
Learn how developing a unified solution can improve quality and create efficiency and cost savings for organizations of all sizes conducting clinical trials of all types.
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How A Strategic Partnership Drove Micro Molding Success
In micro-manufacturing, supplier choice significantly determines success. Explore how one company transformed a struggling production program into a 150-million-part success through trust, scalability, and true strategic partnership.
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The Promise Of PCM: Getting To Maturity
PCM offers a number of advantages, including streamlined development and increased flexibility. Review the key drivers for PCM as well as the hurdles that stand in the way of industry-wide adoption.
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Enhancing Viral Clearance Prediction And Process Optimization
MockV technology enables early, in-house viral clearance assessment, helping biopharma developers improve process robustness, reduce costs, and enhance safety before GMP manufacturing begins.
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Optimizing DSP Development: Faster Timelines, Lower Costs, And High-Quality Processes
The biopharmaceutical industry faces growing downstream processing challenges in purifying complex biologics efficiently and at scale.
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Reframing Clinical Vendor Selection
Explore a platform that enables seamless vendor selection as well as cross-functional collaboration with built-in templates and tailored question libraries that simplify proposal creation and review.
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Increase Production Capacity With Virtualized Process Automation
Learn how Sleeman Breweries grew their production, improved process control, and avoided the high expense of building a new greenfield facility.
NEWS
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Qualcomm And Honeywell Work To Revolutionize The Energy Sector With 5G, Low Power Wireless And Artificial Intelligence-Enabled Solutions11/26/2024
Qualcomm Technologies, Inc. and Honeywell announced an expanded collaboration to develop artificial intelligence (AI)-powered intelligent solutions for the energy sector.
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Zuper Announces Integration With Freshworks For Businesses With Field Operations To Deliver Exceptional Customer Experiences On The Go1/4/2024
Zuper today announced an integration with Freshworks Inc. in the Freshworks Marketplace to enhance customer relationships and experiences for businesses field service teams.
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Tekumo Announces The Launch Of TekumoPRO Version 2.03/11/2025
Tekumo Inc. (TKMO or the "Company"), a leading provider of innovative solutions for On-Demand field service delivery, is excited to announce the release of TekumoPRO Version 2.0.
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Crest Infosolutions Expands Operations In Indonesia, Offering Alfresco ECM And BPM Solutions For Diverse Sectors7/30/2024
Crest Infosolutions, a premier Hyland Alfresco Partner, is excited to announce the expansion of its operations in Indonesia.
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From Demand To Delivery: ToolsGroup Transforms SLF Greece's Supply Chain7/31/2024
ToolsGroup and its Greek partner, THellas, announced that SLF Greece - a distributor of KIKO MILANO products in Greece, Cyprus, Bulgaria, and Romania - has implemented ToolsGroup SO99+ software.