Regulatory Compliance Solutions
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Cleanrooms And Equipment For 503B Outsourcing Facilities
6/9/2023
Germfree understands the unique challenges associated with 503B sterile drug compounding
Sterile drug compounding involves preparing customized medical formulations to address individual patient needs. Key challenges include guaranteeing medication safety and efficacy, adhering to FDA regulations, and managing suitable environmental conditions during the process. Improper compounding can be hazardous, making compliance with standards like USP <797> and <800> vital. 503B providers must also follow FDA regulations, including cGMPs, for outsourcing facilities.
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Transformative Cell Line Development Workflow ClonePix 2 Mammalian Colony Picker
6/21/2023
A transformative cell line development workflow with automated clone screening and optional monoclonality assurance on day 0*
The ClonePix® 2 Mammalian Colony Picker​ is a complete solution for the automated screening and objective selection of high-value clones across diverse cell types.
The ClonePix® 2 Mammalian Colony Picker is a fully automated system for selecting high-value clones used in antibody discovery and cell line development. Screen more clones in less time with monoclonal verification on day zero, then screen and identify for highest producers in weeks, not months.
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Cleanrooms And Equipment For Cell Therapy Drug Manufacturing
6/9/2023
Delivering on the promise of cell and gene therapy through Germfree products and services.
Germfree Laboratories offer advanced modular and mobile facilities, equipment, and comprehensive services for cell therapy manufacturing. Acknowledging the complexity of personalized treatments, Germfree’s adaptable solutions optimize production processes, ensuring aseptic conditions, scalability, and compliance with regulatory standards. This enables efficient, high-quality cell therapy delivery to patients in need, supporting manufacturers in overcoming industry challenges.
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Pick Up To 3000 Colonies Per Hour Using The QPix Microbial Colony Pickers
6/21/2023
Automated microbial screening system capable of picking up to 3,000 colonies per hour
The QPix® Microbial Colony Picker leverages best-in-class colony picking technology to alleviate bottlenecks and quickly, accurately, and efficiently screen through massive genetic libraries. The easy-to-use, intuitive software guides users through setting up colony picking runs where precision robotics pick the right colonies every time.. In addition to microbial screening, the system automates several sample preparation and plate handling processes such as transfer of bacterial liquid culture and plating on agar.
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Manufacturing Science & Technology (MS&T) And Supply Chain
4/27/2022
At Kymanox, the Manufacturing Science & Technology (MS&T) and Supply Chain team, with its global experience in the biopharmaceutical and medical device industries, provides support for all product development phases from early clinical to post-commercial life cycle management.
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Strategic Regulatory Documentation Practice
5/31/2023
Learn how this highly experienced and fully dedicated team is improving timeline creation complexities and management, resourcing, document interdependencies, and transmission to health authorities.
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Bioproduction Regulatory Consulting Capabilities
12/20/2022
Learn more about a service that provides regulatory support, validation guidance, internal consultations, and industry organization guidance while your company implements bioproduction solutions.
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FDA-Registered Detergents
10/7/2020
All Alconox Inc. detergents are Class I Medical Devices and listed as FDA-registered detergents. The list of the detergents is found on the FDA website with FDA Registration number 2410887. Alconox Inc. is also proud to be ISO9001:2015 and ISO13485:2016 Certified.
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Process Development
4/27/2022
At Kymanox, our biopharmaceutical, medical device, and packaging experts establish and improve manufacturing processes guided by Quality by Design (QbD) principles. Our risk-based approach ensures your processes are efficient, consistent, cost-effective, and meet regulatory requirements for safety and quality.
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Regulatory Information Management System (RIMS) Software
8/23/2021
A clear path to global regulatory submissions.