Transform Your Biotech Projects with Our Expert Collaboration !
"We enhance the growth and productivity of your cell cultures, design efficient downstream processes, and ensure the stability and effectiveness of your products."
Close collaboration is our priority to drive your projects to success.
A range of specialized services is provided by our team to ensure the success of your biotechnology projects.
Creating stable, high-performance cell lines and optimizing methods to ensure product quality and reproducibility are areas where our experts excel.
CMC Process Development
The answer is right here!
Our partnership offers a comprehensive suite of specialized services designed to propel your biotechnology projects toward success. We delve deep into process analyses and craft customized designs that elevate both efficiency and quality. Our experienced team works diligently to establish stable, high-performing cell lines while fine-tuning methods to guarantee product quality and reproducibility.
We’re committed to boosting the growth and productivity of your cell cultures, optimizing downstream processes, and ensuring the stability and efficacy of your products. Our strategic control measures are designed to facilitate smooth transitions from the lab to production, and we conduct thorough validation and stability studies to back this up.
Comprehensive Project Management & Holistic Project Control
We take responsibility for all aspects of your project, from the initial concept development to successful commercial production.
This includes detailed planning, precise control, and thorough monitoring of all project phases. With this holistic approach, we ensure that your project is completed on time, within budget, and to the highest quality standards.
We act as your central point of contact, facilitating a smooth process so that you can focus on your core competencies.
Interdisciplinary Team Leadership & Optimized Production Processes
Our strength lies in leading experienced, interdisciplinary teams.
We bring together experts from various fields to ensure optimal collaboration and seamless information exchange.
This enables us to establish efficient and cost-effective production processes. Through our experienced CMO management, we optimize the production of your biologics and ensure that all processes operate seamlessly together.
Regulatory Compliance & Regulatory Expertise
Adhering to current regulatory requirements is our top priority.
We ensure that all processes, from development to production, comply with applicable regulations and guidelines.
Our regulatory expertise minimizes potential risks during approval processes and ensures that your products meet the highest safety and quality standards.
We assist you in creating the necessary documentation and
guide you through the entire approval process
Customer Value
Our comprehensive services are designed to meet your specific needs and ensure efficiency and effectiveness at every stage.
Your biotech projects are driven to success through meticulous attention to detail and a collaborative approach. We offer tailored cell line development, innovative method development, and optimization of media and feeding strategies to maximize productivity.
Our robust downstream process development and expert formulation services guarantee high-quality product yield and stability.
We implement clear control strategies to maintain consistency and quality, and develop scale-up strategies to ensure seamless production expansion.
Our thorough validation and stability studies ensure product reliability, while our support in production transfer and management of Contract Manufacturing Organizations (CMOs) ensures a smooth transition to production.
By prioritizing close and collaborative partnerships, we aim to achieve outstanding results and drive innovation in the biotech industry.
References
Type: pharmaceutical company
Topic: vaccine development
Goal: upstream process development
As a member of the MSAT Team, we were entrusted with the upstream process performance qualification. Our technical and validation expertise in upstream process development and GMP manufacturing was pivotal in the successful BLA application. This collaboration directly contributed to the project's successful market approval, underscoring our commitment to delivering exceptional results in the advanced therapy space.
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Type: pharmaceutical company
Topic: media development
Goal: optimization of CHO cell growth
We executed a comprehensive media development project for a pharmaceutical client, focused on enhancing CHO cell platform performance. Our services included: development of optimized cell growth and feed media, implementation of Design of Experiments (DOE) for process optimization, and in-depth spent media analysis to inform media composition adjustments
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Project
Management
We take full responsibility for your project from initial concept to successful commercial production. This includes detailed planning, precise management, and complete monitoring of all phases. Our holistic approach ensures timely, budget-friendly completion to the highest quality standards.
Qualification & Validation
Our service focus includes document creation for compliance, risk-based project management to enhance quality and safety, and GMP-upgrades to ensure facilities meet evolving regulations and adapt to product changes. We ensure accuracy, efficiency, and regulatory compliance.
Process
Characterization
Our process characterization services ensure your product quality. Our focus is on analyzing critical process parameters and developing TPPs and CQAs for a clear understanding of the product. We define Critical Control Parameters (CPPs) and integrate them into a robust control strategy.
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