cGMP Analytical Services Unit (ASU)

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.

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.

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 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.