mAbs and Recombinants
CUSTOMER CHALLENGE
Monoclonal antibodies (mAbs) and other recombinant biopharmaceuticals require a high degree of specialist QC testing and characterization within a regulated GMP environment. Finding the right partner who can help get your product to the patient, faster and safer can be a challenge, especially if you need to find alternatives to traditional culture or animal-based testing.
PATHOQUEST SOLUTION
PathoQuest can help characterize, QC and release your recombinant mAb across the manufacturing journey
DISCOVERY
PRE-CLINICAL
PHASE 1
PHASE 2
PHASE 3
MARKET
Cell line selection
Cell line characterization – MCB, WCB, End of Production
In-process testing – bulk harvest lot release, biosafety and viral testing
Final product release testing
Raw material screening
Investigatory support
PATHOQUEST SOLUTION
PathoQuest can help characterize, QC and release your recombinant mAb across the manufacturing journey
OUR EXPERTISE
PathoQuest remains at the forefront of NGS for biologic characterization and biosafety testing, especially in the ethical replacement of animal models. We actively participate in regulatory and expert groups, associations and consortia, as well as frequently publishing in peer-reviewed journals. We are leaders both in innovation and acceptance of NGS technology, while continuously improving the characterization and biosafety testing of biologics.
CHALLENGES SOLVED
PathoQuest can give you more confidence in manufacturing and release of your biopharmaceutical product by addressing key concerns:
- Faster cell line development and clone selection with deeper genetic insights
- De-risking your manufacturing process by rapidly screening critical raw materials such as serum
- Reducing the cell line characterization bottleneck, allowing you to get therapy into clinic faster
- Rapidly identify and resolve manufacturing events such as adventitious agent contamination
- Meeting corporate 3Rs ethical objectives by removing animal models
Modalities
mAbs and Recombinants
Bacterial and mammalian produced proteins, hormones and peptides
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Viral Vectors
Viral gene delivery, oncolytic and immunotherapy including manufacturing plasmids
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Cell Therapies
Including gene modified, or unmodified stem cell therapies, allogeneic or autologous
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Vaccines
Inactivated, live-attenuated, recombinant, RNA and viral vector products
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RNA
Immunotherapies, antiviral, vaccines, RNAi and CRISPR based gene editing
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Cultivated Meat
Engineered cells and tissues cultured in more ethical in vitro environments
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Contact us
U.S.
466 Devon Park Dr
Wayne, PA 19087
United States
E: contact@pathoquest.com
Sign up for our latest news
France
+33 (0)1 70 82 17 90
Biopark -Bâtiment B,
11, rue Watt
75013 Paris, France
How can PathoQuest help?
U.S.
466 Devon Park Dr
Wayne, PA 19087
United States
France
+33 (0)1 70 82 17 90
Biopark -Bâtiment B,
11, rue Watt
75013 Paris, France
E: contact@pathoquest.com
How can PathoQuest help?
Sign up for our latest news