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

READ MORE

Viral Vectors

Viral gene delivery, oncolytic and immunotherapy including manufacturing plasmids

READ MORE

Cell Therapies

Including gene modified, or unmodified stem cell therapies, allogeneic or autologous

READ MORE

Vaccines

Inactivated, live-attenuated, recombinant, RNA and viral vector products

READ MORE

RNA

Immunotherapies, antiviral, vaccines, RNAi and CRISPR based gene editing

READ MORE

Cultivated Meat

Engineered cells and tissues cultured in more ethical in vitro environments

READ MORE

Contact us

U.S.

+1 484 212 9360

466 Devon Park Dr
Wayne, PA 19087
United States

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?

Name(Required)
This field is for validation purposes and should be left unchanged.

U.S.

+1 484 212 9360

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

How can PathoQuest help?

Name(Required)
This field is for validation purposes and should be left unchanged.

Sign up for our latest news