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Quality is integral to Yposkesi’s principles

Key Elements of Yposkesi’s Quality Policy include:

  • Risk management: always having the patient in mind, we have developed reliable and robust methods, according to Analytical Quality by Design (AQbD) and designed to be fully EMA and FDA compliant;
  • Support: with extensive expertise, we can develop with our partners a choice of appropriate assays and provide support for the Chemical, Manufacturing and Controls (CMC) requirements;
  • In-house: 75% of analytical tests performed in-house and an external network is well-established for specialized testing.

Platform assays:

  • pH
  • Endotoxin
  • Bioburden
  • Sterility
  • Mycoplasma
  • Total protein (MicroBCA, NanoOrange & Bradford)
  • HCP ELISA
  • Residual Benzonase
  • Total DNA (Picogreen)
  • Residual host cell DNA (SV40)
  • Osmolality
  • Residual Tween (Lysis agent)
  • Residual BSA ELISA
  • Residual host cell DNA total (qPCR)
  • Viral Protein Purity Profile (SDS-Page)
  • Viral Protein Identity (Western-Blot)

AAV specific assays:

  • Vector Genome Titer by qPCR and ddPCR
  • Empty/Full capsid ratio by AUC
  • Empty/Full capsid ratio by ns/cryoTEM
  • Infectious Genome Titer by TCID50
  • Capsid Titer (AAV8, AAV9) (ELISA)
  • Residual Chromatography Ligand quantification (AAV8, AAV9, AAVX,..)
  • rcAAV

Lentiviral specific assays:

  • Infectious genome titer
  • FACS / Cytometry
  • p24 ELISA
  • RCL

 

 

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Product specific assays:

  • Potency
  • Vector ID (Sequencing by Sanger)

In development:

  • Mycoplasma by qPCR
  • Residual transfection agent (PEI, …) by HPLC-CAD

Our Analytical capacity is shared across two teams:

  • current Good Manufacturing Practices (cGMP) analysis within the cGMP Quality Controls (QC) Lab team;
  • Analytical development and transfer, testing for non-cGMP and Pilot scale batches, plus method validation at the Analytical Expertise Center.

Analytical department

The cGMP QC team:

  • Maintains the environmental monitoring testing program for all the classified areas, for the Highly Purified Water (WFI) loop and all other utilities. Those programs consist of routine microbiology assays, bioburden testing, endotoxin, TOC, conductivity etc;
  • Tests all incoming raw materials up to release for cGMP manufacturing;
  • Performs in-process control and release assays on all manufactured products;
  • Runs stability studies.

The testing of your products can be performed internally at the cGMP QC lab or at the labs of qualified sub-contractors, depending on the method, contact us for more details.

The Analytical Expertise Center:

  • The Analytical Expertise Center centralizes all incoming methods, requests or method assessments;
  • Assesses all analytical methods related to a project (method development, transfer, qualification, validation, internal or external assay, etc.);
  • Manages analytical development, transfer and validation according to recipient lab needs;
  • Ensures that methods used are fit for purpose and scientifically sound;
  • Supports all analytical method trouble-shooting.

Test methods are qualified or validated according to product development phase and ICH Q2R1 requirements. As a minimum, the qualification assesses specificity, linearity, matrix interference, accuracy, and precision as applicable. Yposkesi is also routinely applying AQbD approaches to analytical method development, to ensure that our methods are developed to be robust and well-understood.

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