Solutions for Speed, Safety and Scalability in Biopharmaceutical Manufacturing

Further driving this demand is the continued evolution of the pharma and biopharma markets. The pathway for molecules to achieve approvals and reach the market is continually changing, so drug manufacturers rely on technologies that can help them adapt quickly, pivot if needed and deliver efficiencies that help them compete.

Thermo Fisher invests $1.3 billion USD a year in R&D, ensuring we continually innovate to help our customers discover and bring breakthrough therapies to market. 

Additionally, for emerging modalities like cell therapy, manufacturers continue to face contamination risks and higher overall production costs, which can ultimately delay time-to-market for drugs and therapeutics. It’s crucial for cell therapy manufacturers to implement solutions that provide a seamless way for them to scale-out production and automate the workflow.

Biomanufacturers are also facing pressures to develop therapeutics more sustainably. Our customers are looking to implement technologies that help them meet their environmental, social and corporate governance (ESG) goals by using fewer natural resources, lowering their carbon footprint and creating less waste. At Thermo Fisher, we are helping our customers work toward their sustainability goals as they look to meet the increasing global demand for critical therapeutics. This includes innovating more environment-friendly products for use throughout the entire biomanufacturing process. Our sustainability push covers a variety of areas, including minimizing the use of hazardous materials, reducing waste and using fewer resources, increasing energy efficiency, responsible packaging and shipping, and extending the useful life of products and materials.

Automating steps in the workflow is a big step forward towards the ultimate goal, which is to have a closed and automated cell therapy manufacturing process end-to-end, which will require physical and digital integration.

Beyond cell therapy, our automation solutions and tools already help customers across the entire bioproduction process. Examples include fermentation process control in real time with fast, precise gas analysis, magnetic sector mass spectrometry to control the solvent drying process with quick and accurate quantitative data, raw material identification through manufacturing operations, and finished and packaged pharmaceutical product inspection. We helped one of the world’s largest cell and gene therapy pharmaceutical contract development and manufacturing organizations (CDMOs) develop an automation infrastructure and data management system backbone.

Our CTS Detachable Dynabeads can help manufacturers alleviate pain points in process flexibility, compatibility with downstream manufacturing steps and scalability, all while helping reduce the cost of manufacturing and delivering high cell purity, yield and viability. Detachable Dynabeads introduce a higher degree of biological precision into the workflow. This allows cell therapy manufacturers to pinpoint optimal process parameters for cell activation and isolation that enable a flexible and tunable process where the input cells are highly variable. For patients relying on critical cell therapies, CTS Detachable Dynabeads enable greater control and higher efficacy, which can potentially save more lives and create additional options for effective new therapies to treat cancer.

Our PAT techniques help manufacturers obtain a more dependable and cost-effective workflow, all while ensuring consistent product quality by enabling real-time monitoring, control and optimization of critical process parameters. With deep PAT experience developing the software, digital technologies and services that provide complete solutions and support across the bioprocess workflow, we are improving the way products and services are integrated to help support our customers’ digital ambitions. Ultimately, customers utilizing PAT solutions can produce yield faster and at a lower cost, which moves the production pipeline faster and reduces time-to-market.