The development of gene therapies offers both remarkable opportunities and unprecedented challenges. The underlying drivers of many diseases can be addressed with this modality, offering new hope to patients. At the same time, the path to approval is complicated by a lack of robust process templates, an evolving regulatory landscape, and the urgency of unmet medical needs.

In this uncertain environment, where speed and quality are essential, working with an experienced partner will empower you to bring gene therapies to life.

MilliporeSigma, the life science business of Merck KgaA, Darmstadt, Germany, is an industry leader in the field of gene therapy with more than 30 years of experience and broad expertise across the entire workflow. We understand the unique pain points that innovators face, from optimizing upstream and downstream workflows to meeting accelerated manufacturing timelines and navigating new regulatory guidelines. We can proudly state that we were the first gene therapy CDMO to produce a commercial product following a successful regulatory inspection.

Our global organization is ready to address your specific needs with an integrated, customizable offering that encompasses:

  • Industry-leading manufacturing technologies for upstream, downstream, and formulation
  • Process development and scale-up services
  • Viral vector contract development and manufacturing
  • Analytical development and biosafety testing for cell and gene therapies
  • Regulatory support
  • Collaboration labs equipped with scientific experts, innovative technologies, and flexible non-GMP facilities

Rely on our extensive experience to overcome your process development, production, and testing challenges.

Visit our application webpages for more information on products and services for gene therapy development and manufacturing and discover how we’re partnering with innovators to shape the future of this exciting field.


Leveraging experience, knowledge, and expertise from almost three decades of viral vector development and manufacturing, we offer a scalable, reproducible, and efficient development solution to de-risk lentivirus production.

Are you looking for trends, evidence, and data to select the best technologies to develop your bioprocesses? Join Emerging BioTalk.


Millipore® CTDMO Services delivers expertise and flexible solutions for viral vector development and manufacturing to advance cell and gene therapies from preclinical through commercial production.

Perfusion at process development scale

The Mobius® Breez Microbioreactor is a 2 mL automated single-use perfusion cell culture platform designed to support gentle, adaptable, and reproducible cell processes.

Designed to meet the needs of challenging single-use bioprocessing liquid applications, Ultimus® film offers superior strength and leak resistance. This innovative film incorporates woven nylon into a layered polymer structure resulting in increased durability while maintaining the ease of handling, flexibility, and conformity to a bioprocess container that single-use bioprocessing demands.

Immerse yourself in a self-guided, virtual tour of an M Lab™ Collaboration Center!

Processing large batch sizes in one run using single-use equipment is a challenge. The Mobius® TFF 80 system has been designed for large-scale tangential flow filtration, with flow rate capabilities up to 80 L/min and up to 20 m2 of membrane area installed.

Mobius® Essential Assemblies are standard, ready-to-ship, simple bioprocess bag and tubing assemblies for your liquid processing applications.

MilliporeSigma’s Pellicon® Capsules are ideal for single-use ultrafiltration and diafiltration of viral gene therapy and vaccine products.

For High AAV Titers Across Multiple HEK293 Cell Lines

The baculovirus-insect cell system is widely used for production of recombinant proteins and clinical stage AAV due to its flexibility, speed, simplicity, and productivity.

The Sf-RVN® Insect Cell Line is a rhabdovirus-negative Sf9 cell line that can be grown in both adherent and suspension culture. Sf-RVN® Insect Cell Line has been adapted for growth in a chemically defined medium to be used for the production of recombinant proteins, adeno-associated viruses (AAV) and viral-like particles (VLP). The EX-CELL® CD Insect Cell Medium, recommended for use, is optimized to get excellent growth and productivity of the Sf-RVN® Insect Cell Line. Combined, these two products form the Sf-RVN® Platform to help improve the safety profile of your gene therapy.

You’re developing lifesaving gene therapies and need to manufacture AAV vector as quickly as possible. But scale-up and regulatory hurdles make the path to the clinic slow and labor intensive. We’re here to help.

The VirusExpress® 293 AAV Production Platform offers a transfection-based solution using a suspension-adapted cell line, which is GMP banked and characterized, chemically defined medium, and a process with proven performance at clinically relevant scale.

CellPrime® rAlbumin is expressed in Pichia pastoris from a gene construct that encodes a non-glycosylated human albumin.

In recent years, the development of media used to expand and mature adult stem cells has greatly increased the success rate of adult stem cell therapy and the breadth of potential stem cell-based therapies. To obtain enough cells, ex vivo expansion has been utilized to ensure successful engraftment and economize the manufacture of both allogeneic and autologous therapies.

You’ve developed your viral vector gene therapy and now it’s time to embark on the voyage to manufacturing. But gene therapy production is uncharted territory, and you need someone to help navigate through the process. We can help.

You’re developing lifesaving gene-modified cell therapies and need to manufacture lentiviral vector as quickly as possible. But scale-up and regulatory hurdles make the path to the clinic slow and labor intensive.

We're here to help.

For single-use per batch biomolecule purification

A high capacity, high throughput strong anion exchange chromatography membrane designed for single-use per batch biomolecule purification. The unique Natrix® Q membrane contains a high density of quaternary amine ligands that are directly polymerized within the porous membrane scaffold.

Benzonase® endonuclease — the smart solution for DNA removal in biopharmaceutical production.

From your bioreactor to final sterile filtration, the new NovaSeptum® GO sampling system lets you sample processes the way you want. Flexible formats and volumes adapt to your process for robust, reliable monitoring and quality assurance.

MilliporeSigma’s Mobius® single-use mixing solutions deliver advanced technology for mixing pharmaceutical ingredients from intermediate to final drug products and for the preparation of process solutions, such as buffers and media. Unlike traditional stainless-steel mixers, single-use mixers reduce downtime due to CIP, SIP, cleaning validation, and process engineering. Mobius® single-use mixing solutions also offer operational flexibility as they can be up and running in less than five minutes. They are capable of mixing speeds up to 1000 RPMs meeting the broadest range of mixing production requirements. Mobius® flexibility offers you a choice of just the right filter, connector, tubing options for your specific application and environment, including sterile interfaces, from fermentation to final fill. Sizes range from 10 L to 3000 L.

Quality control is a critical component for ensuring safety, efficacy, and consistency in the development and production of biologics. This comprehensive list of strategies, techniques, workflows, and best-in-class products for developing biopharmaceuticals can help you navigate the complexities of biologics and simplify the manufacturing process. Improve your quality control procedures and optimize your biologics production process with tools and expertise relied upon by researchers worldwide.

Culture media selection is of utmost importance, as it directly impacts key elements of your quality control strategy, especially for environmental monitoring in cleanrooms and isolators in aseptic manufacturing. Explore a collection of expert guidance on environmental monitoring and culture media selection, study findings, and innovative solutions that can help you optimize your contamination control strategy. Further, gain insight into the impact of manufacturing guidelines and media features and specifications on environmental monitoring testing.

To effectively monitor product quality, it is critical to test for microbial contamination throughout the pharmaceutical manufacturing process. Sterility testing is a vital step to ensure products purporting to be sterile do not contain viable microorganisms prior to their distribution and administration to patients. Consequently, it is of utmost importance that the testing method employed for products, formulations, tissue materials, and medical devices is both accurate and reliable. Explore a collection of streamlined sterility testing solutions and expert guidance on sterility testing, quality control (QC), and data integrity. Optimize your sterility testing and QC procedures with world-leading tools and technologies that can help you ensure full traceability and regulatory compliance.

Filtration is a critical aspect of pharmaceutical manufacturing, as it helps to ensure the quality, safety, and purity of the final product. This comprehensive list of strategies to reduce bioburden, guidance on filtration selection, and expert insights on regulation, filtration, sampling, and quality control can help you optimize your contamination control strategy and ensure effective filtration in your production process. Explore high-performance specialty membranes and filtration devices relied upon by laboratories worldwide and across the academic, pharmaceutical, biotechnology, and industrial sectors.

Regulatory compliance and traceability are essential for biopharmaceutical companies to ensure the safety and quality of their products. The pharmaceutical industry is heavily regulated, and companies must adhere to a wide range of laws and regulations in order to remain compliant. Traceability is a crucial component of regulatory compliance, as it allows companies to track the history and movement of their products throughout the supply chain. Having a strong focus on traceability and compliance is key to operating a safe and efficient quality control (QC) lab. This comprehensive list of expert insights, strategies, tools, and techniques for achieving complete traceability and regulatory compliance can help you transform your QC lab.



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