Toxicology / Virology (Biopharmaceutical Products)

- In vitro testing for skin corrosion (OCDE TG341);- In vitro testing for skin irritation (OCDE TG439 and ISO 10993-23:2021);
- In vitro testing for eye irritation – HET CAM (ICCVAM)In vitro testing for vaginal irritation (SOP Mattec Epivaginal);
- In vitro testing for Permeation studies of compounds...

Viral vector characterization and release testing services from Intertek's centre of Excellence for Biologics Characterisation, help you to establish and address critical quality attributes (CQAs) that impact product safety, purity, and potency. We deliver robust analytical assays to assess vector pro...

As a world leader in biopharmaceutical testing services, we offer you a comprehensive range of biologics safety testing , including virology, cell and molecular biology, as well as microbiology and electron microscopy. As a result, we can help you to ensure product safety and meet your regulatory requireme...

Performed by 6 DABT/ERT toxicologists.

From pre-clinical development to commercial supply, Patheon by Thermo Fisher Scientific is an industry leader in the development and manufacture of mammalian cell culture drug substances. Patheon offers biotech and pharmaceutical companies the ability to pursue opportunities around the globe with a fully i...

Containment systems for sterile applications may be proposed in the form of closed isolators or Restricted Access Barrier Systems (RABS).
A sterile isolator allows to avoid the use of sterile cleanrooms, reducing the sterile volume around the process being executed.
Turbulent or unidirectional fl...

Single chamber barrier isolator configured in order to grantthe dispensing procedure for API product achieving the followingtasks:• Assure a sterile environment inside the isolator. Assure operator protection, when the processedproducts are highly active.The barrier isolator operates under a positive ...

Affygility Solutions has an extensive database of over 2,300 monographs.

Our OEL/ADE/PDE monographs prepared and endorsed by our in-house DABT/ERT certified toxicologists. This guarantees compliance with regulatory authorities such as EMA, PIC/S, ANVISA, and WHO.

OHC reports are customised safety banding reports for compounds with limited data available. These compounds are usually early stage compounds with little or no human data available.

An OHC report will contain an occupational exposure band (OEB) and an estimated ADE value. The report&...

Safety data sheets are used to determine the potential hazard of the materials being handled.

2 Weeks Turnaround Time

More than 1,000 API substances PDEs have already been developed in house.
  New monographs are being developed on a constant basis.

Any PDE monograph can be developed upon request.

Our rates for PDE monographs are based on several factors such as status of development of the monogra...