ANALYTICAL SERVICES & METHOD DEVELOPMENT
Analytical methods, run alongside formulation development.
We run analytical methods for biologics, ADCs, cytotoxics up to OEB5, and viral therapeutics in the same laboratories that design your formulation. We implement methods from your SOPs, optimize them where needed, or adapt in-house and literature methods.
Our analytics, in numbers
- A credited laboratory for Wyatt Technology in Europe, with separate biologics, cytotoxic, and viral laboratories.
containment for cytotoxic and ADC samples
laboratories, including viral therapeutics
reporting of analytical results
from scope alignment to project start
Formulation decisions are only as sound as the methods behind them.
Each molecule degrades in its own way, and each formulation adds a matrix of buffers, sugars, and surfactants. A platform method can co-elute a degradant with the main peak or read an excipient as product. Formulation variants then look equally stable, and the choice of lead could rest on data that do not separate them.
Methods matched to your molecule
We implement methods from your SOPs and optimize them when your molecule or formulation needs it. Where no SOP fits, we adapt an in-house or literature method, with GLP-like documentation.
Orthogonal methods on file
We read each attribute with one main method and keep orthogonal methods on file: aggregation by SE-HPLC, AF4, and DLS, and charge variants by cIEF, icIEF, and IEX-HPLC.
What we screen for under stress:
- Aggregation
- Fragmentation
- Deconjugation
- Subvisible particles
- Charge heterogeneity
- Residual moisture
Which methods does your stage need?
Most programs start with screening analytics, then test the best formulations with stability-indicating methods. What decides the route is what the data must support: a ranking or a stability study.
Screening analytics
Purpose: Rank formulation variants by colloidal and conformational stability
DLS, nanoDSC, CG-MALS, and SE-HPLC in high-throughput formats
Small amounts, concentrated in centrifugal filter units where needed
Your SOP methods, checked on your molecule at implementation
Ranked variants with the measured parameters behind each rank
Lead formulations move into studies with stability-indicating methods
Stability-indicating methods
Purpose: Separate degradants and variants so stability trends reflect the product
SE-, IEX-, and RP-HPLC, cIEF, CE-SDS, LO, and MFI
Stressed samples from forced degradation to show specificity
Your SOP methods, implemented on your molecule before stability starts
Methods and data for forced, accelerated, and real-time studies
Methods carry through accelerated and real-time stability studies
What's included
Methods are grouped by the quality attribute they read. Each work package starts with a method plan agreed with you. We implement each method first and decide then whether it suits your molecule, before it runs on stability or batch samples.
Size, aggregation, and concentration
- SE-HPLC and AF4
- DLS and CG-MALS
- nanoDSC thermal stability
- Nephelometric turbidity
- Extinction coefficient determination
Charge, purity, and structure
- cIEF and icIEF (CZE with your method)
- IEX-, HI-, and RP-HPLC
- CE-SDS, cGE, and SDS-PAGE
- UPLC (LC-MS with your method)
- Detergent and excipient quantification
Particles and lyophilizates
- Light obscuration and MFI
- Nanoparticle tracking, 10 to 100 nm
- Karl Fischer residual moisture
- Residual solvents by HS-GC-MS
- DSC and SEM of cakes
- Syringeability and injectability (injection force)
Stability-indicating methods need degraded samples, so method and formulation work run together.
A method is stability-indicating only if it separates the degradants your product actually forms. We generate stressed samples in house and use the degradants they contain to show specificity before stability studies start.
The same data show the formulation team which degradation pathways to control. Results are reported within 5 days, so method and formulation work keep the same pace.
Highlight: Our 2025 laboratory expansion added high-resolution mass spectrometry.
Send us your molecule and goals. We'll propose methods.
Under a CDA: your molecule type and structure, target product profile, any existing methods or specifications, and the decision the data must support. You get a proposal with the methods and the timeline. Average client satisfaction: 9 out of 10.
Questions we know you have, and actually helpful answers
How do you choose analytical methods for a formulation project?
We start from your SOP methods and optimize them for your molecule. Where no SOP fits, we adapt an in-house or literature method before it runs on your samples.
Is your analytical documentation suitable for regulatory submission?
Yes. Methods run under your SOPs on regularly calibrated systems, and final reports pass a second, independent review. Documentation follows GLP-like standards suitable for submission to authorities.
Do you measure detergent loss during sterile filtration?
Yes. Detergent content can drop at the start of filtration until the filter membrane saturates. We measure it before and after filtration and set a flush volume.
Can you quantify detergents and excipients in our formulation?
Yes. We quantify sugars and sugar alcohols, amino acids, detergents, buffer substances, antioxidants, and inorganic components, in the final drug product or as in-process controls.
Do you analyze ADC and cytotoxic samples in containment?
Yes. We handle cytotoxic and ADC samples up to OEB5 and SafeBridge category 4, in laboratories physically separated from our biologics and viral work.
Do you determine a protein’s extinction coefficient experimentally?
Yes. ICH Q6B expects the sequence-based value to be supported by an experimental value at least once. We use an absolute gravimetric approach, so glycosylation counts toward the protein mass.
Do you analyze dose formulations for our toxicology studies?
Yes. For the aseptic, non-GMP batches we make for toxicology studies, we confirm concentration, homogeneity, and stability of the dose formulation.
Can you analyze viral vectors and other BSL-2 materials?
Yes. We analyze AAV, adenovirus, lentivirus, and VLPs in our BSL-2 laboratory, separate from biologics and cytotoxics, including aggregation tendency screening by full factorial DoE.
Didn’t find your question? Conversations and quotes are always free.
Let's talk about your analytical methods and what your program needs next.
Our calls get technical quickly. If another partner fits better, we’ll tell you.