Cell & Gene therapy

From early-stage development to post-approval, we partner with pharmaceutical, biotechnology, and medical device clients to overcome regulatory hurdles. Using science as the driver for success, we help our clients achieve positive regulatory outcomes with the Food and Drug Administration (FDA), Europea...

Characterization and release testing of gene therapies: supporting CMC requirements for IND applications and commercial release through expert analysis and stability testing. We provide method development and validation to meet your milestone and regulatory requirement and help you to confirm identity a...

Protect your single-use bioprocess containers: RoSS® Shells - abbreviated for Robust Storage and Shipping - reduce product loss towards 0%. Compatible with all available sizes and types of single-use bags, RoSS enables standardized and scalable end-to-end process solutions for fluid management and col...

Kolon Biotech’s 2D Automated Closed Platform can manufacture adherent cells in large scale with competitive costs and minimum contamination risk. With an automated system using a machine manipulator, we can set up the operation conditions and minimize human error ensuring batch-to-batch consistency. Th...

Pipette tips, centrifuge tubes, PCR prodcuts, culture dish, plates, flasks, serological pipettes, medium bottle etc. Produced in pure raw materials in line with USP-Class VI standard, GMP 100,000 clean workshop production. No pyrogen, no endotoxin, no cytotoxicity.

Vers-A-Tech (Versatile Aseptic Technology) is a semi-automatic or fully automatic modular versatile platform consisting of machines that come together to process bags & nested containers. BAUSCH Advanced Technology Group launched this first of its kind platform to accelerate Cell & Gene Therapy manufacturi...

Platinum cured silicone tubes, peroxide cured silicone tubs, reinforced hoses, TPE tubes, FEp tubes and many more

Bags in fully customizable configurations for bioprocessing, cell culture, and cryopreservation applications, each with key properties based on material.

Let’s light up your gene and cell therapy together. 
Our Pfizer scientists and manufacturing experts are here to help you navigate the path to market for your gene and cell therapy

Experience is crucial when producing life-changing gene and cell therapies, so choosing the right CDMO is...

The Cell Culture ingredients offering provide customers with access to raw materials, like nucleotides, nucleosides, bio buffers, process solutions while also supplying cell culture media ingredients as amino acids and vitamins that further support the needs of biopharmaceutical manufacturers.

B...

KBI's Cell Therapy team, located in The Woodlands, TX, has managed a fully functional manufacturing facility supporting cell therapies and developing therapies under IND since 2001. Our team has substantial expertise and knowledge in cellular therapies' manufacturing, process development, and regulato...

• Integrated VHPS® decontamination system • Special liquid transfer technology for continuous and aseptic filling • Real-time monitoring of the velocity, differential pressure, humidity, temperature • Temperature is adjustable to minimize the influence on products • Critical process parameters...

Solvias offers a comprehensive range of orthogonal analytical methods for ATMPs. Our cell and gene therapy building blocks include raw materials testing, cell culture media specific analysis and oligonucleotide analytics. For gene therapies, vector analytics covers the full range of AAV or LV release a...

Cell Culture Isolator is an isolator designed for laboratory professionals who require aseptic conditions for handling sterile products.
It is specially designed for handling cell cultures in a pharmaceutical context that complies with the GMP guidelines, with marketing authorisation.
In...

Manufacturing of plasmid DNA as starting material for:

• Clinical manufacturing of gene and immuno-oncology therapies, for example in AAV or lentiviral vector.
• Clinical manufacturing of biological drugs.

Quality Highlights:
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The SafeCell® range is made of Fluorinated Ethylene Propylene (FEP) and provides the response to the demands of ex-vivo cell culture. FEP is chemically and biologically inert and perfectly adapted to cell suspension culture.  Its antiadhesive properties allow cells to float freely and develop in their...

For over 20 years, Life Couriers have been training couriers in worldwide stem cell transportation and organizing accompanied transports of stem cell donations for leukemia patients.

With almost 50,000 successfully completed transplant deliveries worldwide, our experienced team and specialist ex...

Our single-use bioreactor simplifies and accelerates cell culture with automation and closed systems, accommodating volumes from 30 mL up to 30 L in the same vessel. Designed for a broad range of cells and for the entire product lifecycle (clinical research, process development, manufacturing).

Good stability: conventional storage at ≤-20°C for one year results in little loss of activity, and after thawing, under aseptic conditions (2-8°C), there is little loss of activity for one month.Animal-free: produced by recombination, free of exogenous viral contamination, and no animal-derived raw materi...

Advanced therapeutics, such as cell and gene therapies, hold immense potential to revolutionize healthcare. However, the path from translational studies to clinical trials and commercial manufacturing is filled with challenges and risks. Therefore, it is essential to partner with a CDMO that possesses ...