Comprehensive Analytical Support for Biosimilars, Biologics and Clinical Programs

Follow us on

Accelerate biosimilar and biologics development and clinical programs with integrated analytical solutions.

Ensure you have the right support with fully integrated analytical services:

Proof of product quality, safety and regulatory compliance is vital for gaining approval for advanced biologics, cell and gene therapies and biosimilars.

From product characterization to stability testing and release, reliable analytical support is essential for successful development and market entry.

Ready to ensure regulatory success?

Get world-leading biosimilar and biologics testing expertise.

We help confirm your products meet quality and regulatory expectations with reliable, scientifically robust analytical support.

From early design to release, get the analytical clarity to de-risk decisions

Request biologics testing guidance

First Name *

Last Name *

Company Email *

Location *

How can we assist you?

Subscribe to SGS Pharma to receive related updates and webinar invitations? *

I agree that SGS can use my data for the purposes of dealing with my request, in accordance with the SGS Online Privacy Statement.

Our specialists will get back to you with tailored guidance.

Vector and product characterization

Comprehensive evaluation of vector identity, purity, quality, strength and potency
Analysis of critical quality attributes for nucleic acid therapeutics, including DNA/RNA vectors, siRNA and antisense oligonucleotides (ASOs)

Biosimilar analytical programs

Structural and functional characterization to establish the originator profile
Comprehensive analytical similarity assessment to establish biosimilarity

Safety and biosafety testing

Bioburden, sterility and endotoxin quantitation
Biosafety testing for plasmid starting materials and cell therapy banks

Method development and validation

Method development, validation and transfer aligned with ICH Q2(R2)/Q14
Fast-track bioassay development for critical quality attributes monitoring

Quality and consistency assessment

Titer assays, physicochemical and functional characterization
Monitoring of key drug substance attributes and contaminants through a full SISPQ testing panel

Release and stability testing

Routine batch release testing for potency, purity, microbiological and physicochemical attributes
Stability programs and biosafety testing from cell bank through GMP manufacturing and clinical phases

Accelerate global development

Shorten development timelines

Enhance comparability and regulatory packages

Improve data-driven decisions

Verify product quality, safety and consistency