Expertise for mAbs Producers
SGS Laboratories
Method development, transfer and validation
Biosafety testing
Batch release testing
Characterization studies
+200 TESTS PER DRUG PER YEAR >95% ON TIME DELIVERY
>1200 PHYSICOCHEMICAL TESTS PER YEAR >200 BATCHES TESTED PER YEAR
<4 WEEKS FAST-TRACK METHOD TRANSFER OF EIGHT BIOASSAYS
>50 CHARACTERIZATION PROJECTS TO US FDA & EMA GUIDELINES
Highest quality GMP biosafety testing facility with 72 segregated BSL-2 labs
Our routine batch release and stability studies include physicochemical, potency, purity, microbiological tests
We are experienced in developing complex assays and fast-tracking method transfer
We applied ICH Q6B across diverse studies from insulin to complex biotherapeutic modalities, ensuring compliance with biologics guidelines
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