Biopharmaceuticals

Bioprocess Services From Process Development to Commercial Manufacturing

Accelerate your time to market with a partner who understands your processes inside out. Our Process Consulting team consists of skilled engineers and scientists who specialize in designing and optimizing biopharmaceutical processes. We integrate our expertise in industry-leading equipment, consumables, process software, and automation to create a comprehensive offering that delivers an efficient manufacturing workflow. 

Our dedicated scientists and engineers have gained valuable insights in various modalities from projects involving monoclonal antibodies, bispecifics, ADCs, recombinant proteins, viral vectors, vaccines, plasmid DNA, and mRNA. Because we develop solutions for all these modalities, we know exactly how to make every component work together. Our process-first approach aims to provide solutions that are tailored to your specific needs, ensuring operational excellence in biopharmaceutical production.

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 Scale-Up, Technology Transfer, Process Characterization

We can support you in identifying, classifying, and ranking of the most important features of your process with the goal of defining a control strategy that ensures consistency and quality of the drug product. Our scalable solutions and digital tools streamline transitions from development to clinical and commercial production.

• Establish the target product profile | quality target product profile
• Perform risk assessments
• Characterize processes and scale-up potential using tools such as design of experiments (DoE) and multivariate data analysis (MVDA)
• Assist with tech transfer activities
• Define proven acceptable ranges (PAR) and the design space
• Develop a control strategy to accelerate GMP readiness

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 Tailored Designs for New and Retrofit Facilities

We offer a broad portfolio of conceptual designs to our clients worldwide tailored for flexibility, scalability, and regulatory alignment.
We have executed >70 conceptual designs for protein-based therapies, and >55 conceptual designs for advanced therapy products.
Our scientists can help you define manufacturing processes, including determining scale and designing individual unit operations, to maximize efficiency and accelerate the time-to-market.

• Calculate mass balance across the entire process 
• Generate process flow diagrams and process equipment layout
• Design media and buffer preparation concepts using single-use systems 
• Develop automation architecture and data collection approaches 
• Optimize space utilization to reduce overall footprint and costs 

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Driving Process Excellence and Advanced Manufacturing Strategies

Our team can support process optimization activities and enhance control strategies to improve yields, increase robustness, and maximize facility throughput while reducing costs. We apply optimization approaches across upstream and downstream processes in both clinical and commercial manufacturing environments.

• Perform a Discover^® Survey (equivalent to a GEMBA walk) for non-binding recommendations post-commercialization
• Provide regulatory support, including reviewing documents and interacting with authorities, if required
• Recommend Regulatory change control filing requirements for second sourcing of critical raw materials 

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ptimal Facility Output and Strategic Insights

Our cost modeling tools are built for transparency, flexibility, and long-term planning to save time, effort, and money. We can apply cost modeling across diverse modalities, scales, and applications to support investment decisions, pricing strategies, and risk analysis.

• Calculate the cost of goods sold (CoGS) for multiple unit operations or end-to-end manufacturing process
• Determine the total cost of ownership (TCO) for single-unit operations for effective product lifecycle management 
• Establish a portfolio approach to cost data to develop harmonized models that support strategic decision making 

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Ensure Compliance with Industry Standards

We can help you accelerate approvals and reduce regulatory risk through our experience in global regulatory submissions and expertise in CMC documentation and product lifecycle management.

• Help navigate complex regulatory landscapes across major markets, including the US FDA, EMA, and Health Canada
• Ensure compliance with industry standards, leveraging expertise in voluntary frameworks such as ICH, ISPE, ISO, PDA and ASTM to streamline approvals

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Webinar

Sartorius End-to-End Single-Use Downstream Solutions

Discover how our latest single-use technologies address the evolving demands of clinical and commercial biopharmaceutical production.

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