Enhance your productivity with solutions that enable scale up

 

While growing and expanding your R&D operations is exciting, it does require companies to think bigger to accommodate more samples, more data, and higher production. And thinking big can bring up new questions. What cell-based assays or in vivo assays can be made more high-throughput? Can your cell engineering be automated or outsourced? Does your data storage need to move into a secure, cloud-based system?

We can equip your operation with high-performing solutions for biotech scale up. Our tools and services scale as you scale, empowering your team to rapidly transition from development to production and commercialization.

 

Products, technologies and services to improve efficiency and scale processes

 

Click tabs to view our comprehensive list of solutions to help you scale

Sample processing

Enhance your productivity and generate superior outcomes with advanced performing, high-throughput solutions for everything from high-throughput nucleic acid quantification to automated sample prep for mass spectrometry.

Instruments and reagents have multi-well plate format solutions to process more samples

Sample preparation

Genetic analysis

Protein and cell analysis

Production

Drive performance and achieve optimal bioprocessing outcomes with our custom services, irrespective of batch size.

Custom products and bulk production services in addition to scale-up production platform itself

Multiplexing

Get the most out of your precious samples with multiplex platforms that offer data accuracy and reduced variability through simultaneous measurement. Our solutions detect multiple analytes from a single sample simultaneously and detect multiple samples in a single run.

Solutions to detect multi analytes from a single sample simultaneously or detect multi samples in a single run

Quick links:    Genetic analysis | Cell analysis | Protein analysis

Genetic analysis

Cell analysis

Protein analysis

Outsourcing

Increase efficiency by partnering with trusted experts, and remove inhibitions caused by acquiring new skills and instrumentation.

Custom services for R&D and Pharma services

Data management

Easily manage your data, and collaborate with partners across a spectrum of platforms with secure, cloud-based instrumentation and software.

Instruments has Cloud-based apps and software enables data analysis remotely

Instruments enabled with 21 CFR Part 11 compliance support software

The FDA released the Electronic Records and Signatures Rule, known as 21 CFR Part 11 in August 1997*. This rule defines the requirements for use of electronic documents in place of paper documents. The law specifies the system elements, controls, and procedures that are necessary to ensure the reliability of electronically stored records.

21 CFR part 11 compliance is composed of both procedural and technical requirements. Procedural requirements are the standard operating procedures instituted by the end user, and technical requirements are the functional characteristics of the compliance management software used. Satisfying the technical requirements does not guarantee 21 CFR part 11 compliance alone. Compliance is the consequence of the end user’s work process and systems used.

Here are our instruments enabled with 21 CFR part 11 compliance support:

* https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application#i (accessed February 27, 2020)
Along with the 21 CFR part 11 software license, our service and support organization offers several services to help you validate your instrument, software, and computer. The following programs are available: IQ/OQ and computer software validation services. Find out more at thermofisher.com/csv

Data storage and management solutions

Instruments with cloud-based software

Instruments with simple and intuitive software that can be used to analyze data away from the bench. Software integration into the Thermo Fisher Cloud platform provides a convenient, centralized analysis and data management solution, enabling you to find more biological info from your data.

Product development

Ease your transition across the entire product pipeline from research to commercialization, with access to commercial-use rights, assurance of best-input materials, and proven quality standards to achieve regulatory compliance.

Solutions meet regulation, OEM, and commercial supply

Sample processing

Enhance your productivity and generate superior outcomes with advanced performing, high-throughput solutions for everything from high-throughput nucleic acid quantification to automated sample prep for mass spectrometry.

Instruments and reagents have multi-well plate format solutions to process more samples

Sample preparation

Genetic analysis

Protein and cell analysis

Production

Drive performance and achieve optimal bioprocessing outcomes with our custom services, irrespective of batch size.

Custom products and bulk production services in addition to scale-up production platform itself

Multiplexing

Get the most out of your precious samples with multiplex platforms that offer data accuracy and reduced variability through simultaneous measurement. Our solutions detect multiple analytes from a single sample simultaneously and detect multiple samples in a single run.

Solutions to detect multi analytes from a single sample simultaneously or detect multi samples in a single run

Quick links:    Genetic analysis | Cell analysis | Protein analysis

Genetic analysis

Cell analysis

Protein analysis

Outsourcing

Increase efficiency by partnering with trusted experts, and remove inhibitions caused by acquiring new skills and instrumentation.

Custom services for R&D and Pharma services

Data management

Easily manage your data, and collaborate with partners across a spectrum of platforms with secure, cloud-based instrumentation and software.

Instruments has Cloud-based apps and software enables data analysis remotely

Instruments enabled with 21 CFR Part 11 compliance support software

The FDA released the Electronic Records and Signatures Rule, known as 21 CFR Part 11 in August 1997*. This rule defines the requirements for use of electronic documents in place of paper documents. The law specifies the system elements, controls, and procedures that are necessary to ensure the reliability of electronically stored records.

21 CFR part 11 compliance is composed of both procedural and technical requirements. Procedural requirements are the standard operating procedures instituted by the end user, and technical requirements are the functional characteristics of the compliance management software used. Satisfying the technical requirements does not guarantee 21 CFR part 11 compliance alone. Compliance is the consequence of the end user’s work process and systems used.

Here are our instruments enabled with 21 CFR part 11 compliance support:

* https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application#i (accessed February 27, 2020)
Along with the 21 CFR part 11 software license, our service and support organization offers several services to help you validate your instrument, software, and computer. The following programs are available: IQ/OQ and computer software validation services. Find out more at thermofisher.com/csv

Data storage and management solutions

Instruments with cloud-based software

Instruments with simple and intuitive software that can be used to analyze data away from the bench. Software integration into the Thermo Fisher Cloud platform provides a convenient, centralized analysis and data management solution, enabling you to find more biological info from your data.

Product development

Ease your transition across the entire product pipeline from research to commercialization, with access to commercial-use rights, assurance of best-input materials, and proven quality standards to achieve regulatory compliance.

Solutions meet regulation, OEM, and commercial supply

TOP

 

Biotech scale-up success stories

 

For biotech companies, finding opportunities to scale processes throughout research and development can save valuable time and increase efficiencies during several stages of your workflow. For example, in the sample preparation stage you can scale recurring steps such as cell isolation, DNA, and RNA isolation to improve time efficiencies. In the drug candidate testing and optimization stage, analyzing samples at a higher throughput and the quality of data are key to progressing drug discovery forward. Additionally, biological function of therapeutic drugs, vaccines and diagnostic tools can be scaled for testing in both cell based assays and in vivo assays by using flow cytometry and imaging. Read our biotech success stories to learn how other companies have successfully scaled stages of their research.

Style Sheet for Global Design System