We stress your lead formulations, identify how they degrade, and use the results to choose and refine the formulation. Stress studies run as part of formulation development.
stability studies in our laboratories
containment for ADC studies
laboratories for biologics and viral therapeutics
from scope alignment to project start
Biologics degrade by chemical routes such as oxidation and hydrolysis, and by physical routes, including unfolding, aggregation, and particle formation, often at the same time.
A stress that is too harsh can open pathways the product may not meet in storage, and one that is too mild can leave real liabilities undetected.
We choose each stress from the molecule, its formulation, and the route of administration, in line with ICH Q8 Quality-by-Design, so the pathways we find are ones your product could meet.
We read every stressed sample with the same method set: aggregation and fragmentation by chromatography and electrophoresis, charge variants, and sub-visible particles. Orthogonal methods available and optional.
Stress studies come first: they show how the molecule degrades and which formulation protects it. Accelerated and real-time studies then follow several lead formulations under defined storage conditions, and real-time data forms the basis of the shelf life. In-use studies cover the last step, from vial to patient. Each answers a different question.
Answers: How does this molecule degrade, and what protects it?
Heat, light, oxidation, pH, freeze-thaw, agitation, and surface contact
From candidate selection through late development, and for process changes
Formulation, handling, and stability-indicating methods
ICH Q5C, Q1A(R2), and Q1B, with conditions chosen case by case
The main degradation routes and a shortlist of protective formulations
Answers: Which lead formulation stays most stable over time?
Defined storage temperatures, at intended and elevated levels
On several lead formulations, to choose the best one
Shelf life, storage conditions, and the stability program for filing
ICH Q5C for biologics and ICH Q1A(R2) for small molecules
Stability data over time on the final formulation in its primary packaging
Answers: Does the product stay stable from vial to patient?
Dilution, infusion or injection, hold times, and handling steps
Ideally at formulation selection, before the formulation is locked
Compatible diluents, consumables, hold times, and administration instructions
Pharmacopeial requirements (Ph. Eur., USP) for appearance and particles
Recovery, particle, and degradation data under clinical handling conditions
We agree the stress design with you before the first sample is stressed. Molecule and process stress run in parallel where material allows, and every sample goes through the same analytics.
The go/no-go point is the stress results, which show which formulations move on to stability studies.
Agitation at air-liquid interfaces and contact with silicone oil can drive aggregation, and light can drive oxidation. We stress each lead formulation under the same conditions, so differences come from the formulation.
Highlights: in one program, a detergent and an antioxidant were both needed for the lead formulation to pass light, agitation, and freeze-thaw stress.
Agitation at air-liquid interfaces and contact with silicone oil can drive aggregation, and light can drive oxidation. We stress each lead formulation under the same conditions, so differences come from the formulation.
Highlights: in one program, a detergent and an antioxidant were both needed for the lead formulation to pass light, agitation, and freeze-thaw stress.
Under a CDA: your molecule type, the formulations under consideration, known liabilities, the planned route, and the material available. Stress studies run within a formulation development project.
It exposes a molecule to stress beyond normal storage to reveal how it degrades. The results show which quality attributes to watch and which formulation and process protect the molecule.
Forced degradation uses stress beyond storage conditions to find pathways. Accelerated stability holds the lead formulations at elevated, defined conditions over time. ICH Q5C treats both as support for real-time data.
During formulation development, once lead formulations exist, and again when a major process or site change calls for a comparability study. ICH Q5E notes that stress studies give a direct comparison of pre-change and post-change product.
Yes. We stress ADCs and their antibody intermediates under containment up to OEB5 (SafeBridge category 4), and read aggregation, fragmentation, and charge variants on the same samples.
No single guideline covers it. ICH Q5C covers stress studies for biologics, ICH Q1B covers light exposure, and ICH Q5E covers stress studies for comparability after a process change.
Enough to reveal the main pathways without creating artifacts. We set the target per molecule and stress type, and adjust conditions after a first range-finding round.
Yes. We stress the lyophilizate and the reconstituted solution, and check residual moisture and cake structure in the lyophilizate.
Yes. We document studies under our quality system, with reports suitable for submission to authorities. Stability studies that need GMP then run at a GMP site you choose.
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