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CMO - Manufacturers of Diagnostic and Therapeutic Monoclonal Antibodies | BioVolutions

BioVolutions is a pharmaceutical development and manufacturing organization founded in 2005, licensed as a biomedical facility in the State of Massachusetts.

http://www.biovolutions.com/

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Ivrea, Inc.

Maurizio Cattaneo

196 S●●●●●t Ave

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BioVolutions Inc.

Maurizio Cattaneo

196 S●●●●●t Ave

Qu●●cy , Massachusetts, 02169

United States

1.61●●●●8030
mc●●●●●●●@biovolutions.com

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BioVolutions Inc.

Maurizio Cattaneo

196 S●●●●●t Ave

Qu●●cy , Massachusetts, 02169

United States

1.61●●●●2491
mc●●●●●●●@biovolutions.com

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CMO - Manufacturers of Diagnostic and Therapeutic Monoclonal Antibodies | BioVolutions | biovolutions.com Reviews
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BioVolutions is a pharmaceutical development and manufacturing organization founded in 2005, licensed as a biomedical facility in the State of Massachusetts.
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1 biovolutions
2 therapeutic antibodies
3 cell line development
4 monoclonal antibodies
5 antibody purification
6 pharmaceutical development
7 manufacturing
8 single use systems
9 SUS
10 biomanufacturing
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CMO - Manufacturers of Diagnostic and Therapeutic Monoclonal Antibodies | BioVolutions | biovolutions.com Reviews

https://biovolutions.com

BioVolutions is a pharmaceutical development and manufacturing organization founded in 2005, licensed as a biomedical facility in the State of Massachusetts.

INTERNAL PAGES

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1

Analytical Development | Biovolutions

http://www.biovolutions.com/analytical-development

Why Partner With Us? What are the Steps? What Do We Do? Analytical methods for monoclonal antibody manufacturing, are normally developed to support cell culture and purification development, quality control testing, and characterization of the bulk drug substance and final drug product. Analytical method development and transfer. Qualification and validation of analytical methods. Testing of intermediates and finished antibody drug products. Stability testing (ICH guidelines). HPLC for IgG determination.

2

What Are The Steps? | Biovolutions

http://www.biovolutions.com/the-steps

Why Partner With Us? What are the Steps? What Do We Do? What Are The Steps? CMC is one of the most critical and time-consuming tasks required to enable both preclinical as well as human clinical testing of a new monoclonal antibody or recombinant vaccine candidate. Under a Confidential Disclosure Agreement BioVolutions and its client share data on the antibody, the project, the objectives,and the technology. A feasibility study agreement is signed following the approval of the work plan. Woburn, MA 01801.

3

Continuous Biomanufacturing of Therapeutic Monoclonal Antibodies | Biovolutions

http://www.biovolutions.com/manufacturing

Why Partner With Us? What are the Steps? What Do We Do? Continuous Biomanufacturing of Therapeutic Monoclonal Antibodies. Small Scale (1-3g) Manufacturing of Monoclonal Antibodies. Purification of the monoclonal antibody is accomplished through coupling with Continuous Protein A chromatography. With this technology, Biovolutions can manufacture gram quantitites of high quality monoclonal antibodies (Endotoxin 0.5 EU/mL; Purity 97.5%) in a timeframe of 3-4 weeks at very. In our Clinical Manufacturing faci...

4

What Do We Do? | Biovolutions

http://www.biovolutions.com/what-we-do

Why Partner With Us? What are the Steps? What Do We Do? What Do We Do? We provide Small-Scale as well as Clinical Scale Manufacturing services for your monoclonal antibody (mAb) product for your safety and dose-ranging studies:. Process Development of Monoclonal Antibodies:. Cell Banking to generate 100mL batches of high density cultures (up to 100 x 106 cell/mL. Process Controls using Finesse Delta-V software (21 CFR Part 11 Compliant). Custom Manufacturing of Monoclonal Antibodies. Woburn, MA 01801.

5

Cell Line Development | Biovolutions

http://www.biovolutions.com/cell-line-development

Why Partner With Us? What are the Steps? What Do We Do? Development of a suitable genetically-modified, engineered cell line capable of producing glycosylated proteins such as monoclonal antibodies or recombinant proteins with sufficiently high productivity is one of the most time-consuming CMC development activities. Using state-of-the art selection methods and validated cell lines optimized for high titers and protein quality, cell line development can take 3-6 months to complete. Woburn, MA 01801.

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Why Partner With Us? What are the Steps? What Do We Do? CMO - Manufacturers of Diagnostic and Therapeutic Monoclonal Antibodies. BioVolutions has developed an improved,. And highly cost-effective L929 cytotoxicity assay (CHOTOX. That has almost a five-fold increased sensitivity for leachates derived from components in e.g. in single use technology compared to standard tests performed in serum-containing media. BioVolutions specializes in manufacturing of custom high quality diagnostic and research antibo...

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