Webinars

 

How to ensure quality and compliance in implementation of single use systems

Watch this educational webinar and discover valuable risk mitigation strategies addressing important issues such as integrity or particulates, both in the area of rigid or flexible single-use systems.

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AAV manufacturing for clinical and commercial gene therapies

In this webinar, Thermo Fisher Scientific describe how they are mobilizing to meet rapidly growing demand for AAV vector from both technology development and manufacturing strategy viewpoints.

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Development and Validation of Quantitative Real-Time PCR for the Detection of Residual HEK-293 Host Cell DNA

In this webinar, we share the development and validation of a new, and highly sensitive and accurate solution for detecting and quantifying residual HEK293 host cell DNA to help meet regulatory requirements.

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Webinar
Global Regulators' FAQs on CMC in IND/BLA Filing

Hear from our experts: A retrospective look at past Mycoplasma validation queries and responses

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Validation Guidance for Residual Host Cell DNA Testing

Watch this webinar and learn more about validation of a qPCR assay for residual host cell DNA quantitation.

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Videos

 

Thermo Scientific Bioprocess Equipment and Automation Solutions from R&D to Production

Research and development, process development, and pilot plants involved in scale-up and technology transfer can face significant setbacks such as time and data loss due to a lack of efficient, traceable data transfer.

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Downloadable documents

 

6 critical considerations for bioprocess lab equipment selection

As the market develops a need for more open and flexible systems, special attention should be paid to how your bioprocess equipment meets both present and future facility and process requirements.

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Affinity chromatography accelerates viral vector purification for gene therapies

A case study demonstrates that affinity chromatography can offer efficiency and scalability for gene therapy manufacturing using viral vectors.

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Affinity tags head toward the vaccination clinic

Protein purification is a tricky business. Read the article to find out more on affinity chromatography purification.

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Automation and Data Management Across Biomanufacturing Workflows

As the market develops a need for more open and flexible systems, special attention should be paid to how your bioprocess equipment meets both present and future facility and process requirements.

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Automation, modularity allow mAb biotech to cut scale-up time

Original developers of biosolutions and products, especially those facing the debut of biosimilars in core markets, have an urgent imperative to reduce manufacturing costs via increased productivity and yields. In turn, this drives a wide range of business decisions, including capital investment, process choices and design, and equipment selection.

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Bispecifc Antibodies Exploits Differential Chain Expression and Affinity Capture

Generation of bispecifc antibodies (BsAbs) having two unique Fab domains requires heterodimerization of the two heavy chains and pairing of each heavy chain with its cognate light chain.

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Development of purification steps for several AAV serotypes using POROS CaptureSelect AAVX affinity chromatography

Learn more about Capture Select technology minimizing the steps in the purification process.

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Enabling cell & gene therapy raw materials standardisation

The quality of raw materials needs to be considered according to the stage of development of the cell or gene therapy.

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Improving aggregate removal to enhance clinical manufacturing of MAbs

Hydrophobic interaction chromatography (HIC) in flow-through mode offers a more efficient and cost-effective polishing/purification process.

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Meeting the global demand for non-monoclonal antibody biosimilars

Biologics have transformed patient treatment by offering new and effective medicines for a range of chronic and acute conditions.

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Microbial Risk Management

Four Strategies to Protect Your Bottom Line.

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Microbial Testing: Five Myths Vs. Reality

Five Myths Vs. Reality for Microbial testing.

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Novel Hydrophobic Interaction Chromatography Resins

Using the POROS resins, a HIC step can be easily implemented resulting in increased yields and reduced processing times through effective and efficient removal of impurities.

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Overcoming downstream purification challenges for viral vector manufacturing

Enabling advancement of gene therapies in the clinic.

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Rapid Implementation of Novel Affinity Purification

Manufacture of Commercial-Scale Next-Generation Antibody Therapies

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Rapid implementation of novel affinity purification

Production processes have become more efficient because common purification processes are being used across structurally similar MAbs during key steps of process development and manufacturing.

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Regulatory FAQs for cell and gene therapy
Regulatory FAQs for cell and gene therapy

This article focuses on key regulatory considerations and requirements across the cell and gene therapy raw and starting materials area.

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Upstream and downstream solutions for AAV manufacturing

With the advancement of gene delivery vectors and gene editing technologies, cell and gene therapies are a very real solution to many previously untreatable or difficult to treat diseases

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Validated shipping of filled Labtainer Pro BioProcess Containers

Growing competition across the biomanufacturing industry is resulting in a greater need for efficiency and speed at all stages of development and manufacturing. Read the full application note.

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Bioprocessing resources

Access a targeted collection of scientific application notes, case studies, posters, white papers and more for bioprocessing:

Style Sheet for Global Design System