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Analytical Development and Quality Control

Cost-Effective Quality Control Solution

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CDMO Solutions Analytical Development and Quality Control

Analytical Development & Quality Control

Our analytical teams at Porton Advanced Solutions have enriched experience in method development, verification, validations in a wide range of Advanced Therapy Medicinal Products(ATMPs).

By being partnered with more than 50 ATMPS projects, we have established our technical competencies in various testing platforms, including but not limited to viral vectors, bacterial vectors, and mRNA.

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50+
ATMPS Projects

Quality Control Solution

Cost-effective quality control solution

GMP QC 
Platforms

GMP QC platforms in compliance with FDA, EMA, and NMPA filings

Timely

Timely delivery of services and results

Custom

Customized method development and validation services

Our Cutting-edge Analytical Platform

Our analytical platform provides assays developed on advanced instruments and broad sample matrices to support the development and characterization of ATMPs.

These state-of-the-art instruments include LC-MS, AUC, ddPCR, advanced
microscopy systems, and cutting-edge flow cytometers, among others.
These instruments precisely analyze various aspects of ATMPs, from the identification and quantification of specific molecules to the evaluation of therapeutic efficacy and safety.

What We Can Offer

At Porton Advanced, we have developed more than 300 different assays and are providing standard testing services to our clients.

300+
Different Assays
7 Functional Platforms
Characterization
Physicochemical
Molecular
Biochemical
FACS
Microbiology
Cell Function

  • Characterization

    LC-MS,AUC,Stunner

    • mRNA capping ratio
    • PolyA tail
    • AAV empty to full ratio
    • mRNA purity

  • Physicochemical

    HPLC/UPLC, CE, UV

    • Supercoiled plasmids
    • DNA fragments
    • mRNA integrity
    • Cap analogs

  • Molecular

    PCR,q-PCR,dd-PCR,WB

    • Target gene identification
    • Genome titer
    • Residual HCD/HCR
    • Mycoplasma

  • Biochemical

    SpectraMax M5e

    • Residual HCP
    • P24
    • Residual dsRNA/Antibiotic/Medium
    • LNP encapsulation

  • FACS

    Flow cytometry,Inverted Microscopee

    • Phenotyping
    • Multi-cytokine release
    • Antigen Expression
    • Ex vivo affinity..

  • Microbiology

    Isolators, Rapid sterility system

    • Cell bank Analysis
    • Sterility tests
    • Endotoxin
    • Bioburden

  • Cell Function

    RTCA

    • Cytotoxicity
    • IFN-Y secretion
    • Trilineagedifferiation
    • Soft agar cloning

Seven Functional Platforms

The seven functional platforms are based on the combination of advanced instruments and broad sample matrices empowering researchers and developers to gain comprehensive insights into the molecular and functional attributes of ATMPs. This optimizes production processes, identifies potential biomarkers, assesses product quality, and ensures the safety and efficacy of these innovative therapies.

With an extensive array of analytical capabilities, Porton Advanced serves as a valuable resource for advancing the field of ATMPs, ultimately bringing novel treatments to patients in need.

More About Our Platforms

Our Services

Plasmid

  • Lentivirus
  • Supercoiled plasmids
  • LcDNA

Viral Vectors

Cell Engineering

mRNA

Investigator- initiated trials

Analytical Development and Testing Services

A wide range of analytical development and quality control services are being provided by our AD & QC team who possess strong expertise in process/product characterization, identification of critical quality attributes, specification and stability study design, testing services for ATMPs products, and c-GMP compliant lot release testing.

Method Development
Method Validation & Verification
Method Transfer
Reference
Standardization
Life Cycle Management
of Methods

Analytical Development and Testing Services

Analytical Method Developmentand Testing
Quality Study and CQA Evaluation
R&D Sample Testing cGMP-compliant Testing(COA)
Stability Study
Lot Release Testing
Support In-house Projects
Analytical Development and Testing Services

The Analytical Procedure Lifecycle Management

At Porton Advanced, we have built a robust system for analytical procedure life cycle management as we understand that the documentation from the AD & QC team accounts for over 70% of IND filings.

Therefore, we designed our process to provide integrated testing services from the preclinical to the commercial stage.

    • Method Gap Analysis
    • Method Development/
      Optimization

    AD

    To kick start a project, our AD team will do a method gap analysis depending on the sample matrix, and after considering the manufacturing process, they will initiate method development or method optimization dependent on the client transferring their internal method.

    • Analytical Charaterization
    • Method Verification/ Validation

    AD & QC

    The AD & QC team will then perform process characterization, and method verification/ validation.

    • Raw Material Release
    • GMP Lot Release Testing
    • Stability Study

    QC GMP

    During the GMP stage, the QC team will take ownership of performing lot release testing, raw material release, and stability study.

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    Porton Expert Team Today

    Clients & Partners

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