Critical quality attributes

Characterization and testing of biopharmaceuticals: Using our expert's insight into a biologic's structure, physicochemical properties, potency, and impurity profile, we help you meet your development milestones.

A range of expertise is available, including assessment of structure...

Skyepharma is experienced with the scale-up of complex oral solid dosage forms from laboratory to pilot-scale and full commercial scale manufacturing. We have powerfull compaction simulation tools ( STYL'One evolution) allowing to derisk and fasten scale-up steps. 
Our capabilities :...

The Walk-In Cooling Cabinets / cold rooms are designed according to ICH guidelines, WHO, MCA and USFDA requirements to maintain uniform conditions. They are superior in airflow distribution, temperature control technology, cabinet construction and are manufactured as per cGMP regulations.
Biggest Walk...

Laboratory services according to GMP and CMC: We provide regulatory-driven, phase-appropriate laboratory services, supporting CMC programs from preformulation to formulation to product release. Among our capabilities are centres of excellence for method development and validation, analysis, stability s...

Analytical development services for oligonucleotides: For oligo-based drugs, our capabilities range from GLP bioanalysis to GLP/cGMP characterisation. We support product development, from quality control testing of amidite starting materials and early stage product characterization through to GMP batch r...

Characterization and analysis of mRNA supporting vaccine and therapeutic development, including assessing clinical translation efficiency and immunogenicity. At our GLP / GCP / GMP laboratories, scientists can test a mRNA drug substance or drug product to help you confidently assess batch to batch manufa...

Characterization and release testing of gene therapies: supporting CMC requirements for IND applications and commercial release through expert analysis and stability testing. We provide method development and validation to meet your milestone and regulatory requirement and help you to confirm identity a...

Our vaccines development experts provide a suite of services supporting the analysis and quality control of process and batch release samples and stability studies. We have support the development of a range of vaccines including mRNA, protein, glycoprotein, DNA, carbohydrate, lipopolysaccharide, lipi...

Identification and quantification of genotoxic impurities: To reduce drug safety and quality risks, diagnosing and limiting genotoxic impurities early on in drug development can reduce risk associated with genotoxic impurities. With the implementation of increasingly stringent regulations for impurity l...

Our vaccines development experts provide a suite of services supporting the analysis, delivery, quality control of process and batch release samples and stability studies. We have support the development of a range of vaccines including mRNA, protein, glycoprotein, DNA, carbohydrate, lipopolysaccharide, li...

We provide higher-order structure analysis to drive insight into the secondary and tertiary structures of protein in “normal “presentation as well as a function of temperature and pH, allowing the study of subtle structure changes that may occur during processing, storage or handling as well as protein agg...

Our scientists use Real-time qPCR and digital droplet PCR (ddPCR) techniques for robust quantification to support process validation, monitor batch to batch variation and support of GMP lot release, helping to ensure that products produced from a range of common host cell lines (HEK293, E.coli an...

Our GMP compliant laboratories provide pharmaceutical impurity testing for new drug substances (ICH Q3A(R2)) and new drug products (ICH Q3B(R2)) which can support your product development from an early stage and across the lifecycle of your drug product including method development / validation and di...

Intertek has over 30 years’ experience in biologics characterisation, from small peptides up to monoclonal antibodies and conjugated species, and contract testing, formulation and clinical manufacturing services supporting orally inhaled and nasal drug product development. The Intertek Centre of Excellence...

Fundamental to your biopharmaceutical chemistry, manufacturing and controls (CMC) development, you will need detailed analytical characterisation data to satisfy regulatory requirements. Our experts strategically deploy orthogonal protein analysis approaches that address key molecular and biological charac...