cGMP Analytical Services Unit (ASU)

Advanced bioanalytics to support iBET’s R&D activities and GMP (Good Manufacturing Practices) analytical services for Pharmaceutical and Biotech companies.

Bioanalytics and GMP analytical services at iBET

iBET’s Analytical Services Unit (ASU) offers comprehensive analytical support to biotechnological companies, particularly for the development and manufacturing of advanced therapeutic medicinal products (ATMPs). Some of these products are already in clinical trials.

Our focus lies in developing novel advanced methods, particularly Bioanalytics and Mass Spectrometry-based approaches for the characterization of complex biological products. A wide range of assays are performed, including molecular identity and structural integrity determination, potency and viral titer assays and impurity profiling.

ASU is certified by both INFARMED (Portuguese Authority of Medicines and Health Products – representative of EMA) and DGAV (Portuguese Authority for Food and Animal Health) to undertake quality control and batch release activities for commercial and investigational human and veterinary medicinal products, under GMP compliance.

ASU focuses its activities on two main areas: Analytics for Biopharma R&D and GMP Analytical Services.

Analytics for Biopharma R&D

ASU provides specialized support to iBET’s research groups and partners with a wide range of analytical services covering every step of Bioprocess Optimization.

Our expertise includes implementation and development of chemical, biological, molecular biology, and cell-based assays.

GMP Analytical Services

In addition, our dedicated team specializes in method development, implementation, validation, and transfer.

ASU’s in-house capabilities allow the implementation and validation of analytical assays essential for quality control of raw materials, in-process control samples, drug substances, and final products. This is crucial for the characterization of product’s quality attributes during process development or GMP manufacturing.

Our quality management system ensures validation policies are aligned with the ICH method validation guidelines ICH Q2(R2).

ASU in numbers (2023)

17

R&D partners (8 Academia + 9 Industry)

600

GMP analytical tests in 17 different products

73

Internal requests (from iBET's biopharma R&D labs, satellite labs and Late-stage and Bioproduction Unit)

Equipment & Facilities

ASU has a total area of 500 m2, including 100 m2 of a classified area with a dedicated custom design HVAC system. Our classified area is equipped to handle products up to biosafety level 2, including viruses.

The main equipment room is supported with chillers for temperature control and has a GC-FID, a FTIR, two ULPC and one HPLC with various types of detection, namely diode array, UV-visible, refraction index, and fluorescence. Additionally, a sub-room is equipped with two Real-Time PCR systems and with Olink Signature Q100 which uses the Proximity Extension Assay technology.

The unit also has dedicated rooms for sample reception, sample preparation and standard handling.

Related Technologies

Cell line development
Molecular Identity and Structural Integrity and Purity
Potency and Titers
Impurity Profiling
Chemical Analyses

Related Teams

Mass Spectrometry Unit Team
Patrícia Gomes-Alves

Head of the Sanofi Satellite Lab | Coordinator of Analytical Services Unit and Mass Spectrometry Unit

Mass Spectrometry-based R&D services to support our partners in bioprocess understanding & development and in-depth characterization of biologics.

Analytical Services Team
Patrícia Gomes-Alves

Head of the Sanofi Satellite Lab | Coordinator of Analytical Services Unit and Mass Spectrometry Unit

Advancing bioanalytics development to support iBET’s R&D activities and perform GMP-certified analytical services for Pharmaceutical and Biotech companies.

Highlights

Multi-year agreement established with GeniBET-ReciBiopharm
A multi-year agreement was formally established with GeniBET-ReciBioPharm spanning the years 2024 and 2025, reinforcing the long-lasting relationship.

A multi-year agreement was formally established with GeniBET-ReciBioPharm spanning the years 2024 and 2025, reinforcing the long-lasting relationship.

To manage the increased bioassay workload and broaden our expertise, the team was strengthened with four additional members, three of whom holding PhD degrees.

First lot release for clinical trials
In September 2022, a protein drug product GMP lot was analysed and released by iBET’s Quality Person to be used in clinical trials.

In September 2022, a protein drug product GMP lot was analysed and released by iBET’s Quality Person to be used in clinical trials.

This work was performed for a UK collaborator, and it was the first time that the complete process, from GMP analytics to assay release was performed at ASU.

Reorganization of classified area to increase capacity and efficiency
During 2024, the classified area of ASU is under reorganization to expand its capacities to take on more projects.

During 2024, the classified area of ASU is under reorganization to expand its capacities to take on more projects.

With the acquisition of new equipment, increased staffing, and improved facilities, we are now able to handle a greater volume of work with enhanced efficiency and quality.

This reorganization enables ASU to better support our partners’ needs and accelerate their projects.

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