Email Us
Call Us
Nanoparticle formulation protects a payload from degradation, extends circulation time, directs distribution toward some tissues and away from others, and provides a route across the cell membrane. For nucleic acid therapeutics it is not an optimization step but a precondition, since unprotected siRNA, microRNA, mRNA, and plasmid DNA are degraded rapidly in circulation and do not enter cells unaided.
Altogen Labs formulates nanoparticle systems to the payload and the intended target tissue, characterizes each preparation, and carries formulated material directly into in vivo delivery and biodistribution studies in the same facility. To discuss a formulation requirement, request a quote.
System selection
Lipid nanoparticles are the established approach for nucleic acid delivery. Composition governs behavior: the ionizable lipid drives endosomal escape, which is frequently the limiting step rather than cellular uptake; helper lipid and cholesterol govern particle stability; and polyethylene glycol density on the surface governs circulation time and the propensity for protein adsorption.
Polymeric systems are selected where payload characteristics, loading requirement, or release profile are not well served by a lipid system. Conventional liposome encapsulation remains appropriate for many applications and for payloads with an established liposomal precedent.
Selection follows the payload and the target rather than institutional preference, and where the answer is not obvious, formulating two candidates and comparing them in vivo settles it faster than deliberation.
Characterization
Particle size, polydispersity, surface charge, encapsulation efficiency, and payload integrity are measured for each preparation, and each has a direct bearing on in vivo behavior. Size governs distribution and clearance. Polydispersity determines whether a measured size describes the population or its average. Surface charge affects protein adsorption and clearance route. Encapsulation efficiency determines how much of a nominal dose is actually delivered as formulated material rather than as free payload.
Characterization is performed on every batch rather than assumed equivalent to a previous preparation, because batch variation in these parameters is common and a formulation performing differently between studies is usually explained by a characterization value that was never measured.
Microfluidic production
Microfluidic mixing controls the conditions under which particles self-assemble more tightly than bulk methods, producing narrower size distributions and better reproducibility between batches. It is used where consistency matters, which includes any program where formulations are compared between studies or where a formulation will be scaled.
From formulation to in vivo result
Formulating and testing in one facility means a disappointing in vivo result can be diagnosed rather than merely observed. When a formulated nucleic acid fails to produce knockdown in the target tissue, the cause may be particle instability, clearance before arrival, failure to enter cells, endosomal entrapment, or insufficient payload potency. Distinguishing between them requires the characterization data and the in vivo material together.
Altogen Labs measures accumulation in target and clearance tissues, target transcript reduction by quantitative PCR, and target protein reduction by Western blot and ELISA, within the same study that assessed the formulation.
Applied examples
Composition comparison. Two formulations differing in polyethylene glycol density are administered in parallel, with circulation time and liver to spleen distribution compared, identifying which to carry into efficacy before efficacy animals are committed.
Endosomal escape. A formulation showing good tissue accumulation but poor knockdown is reformulated with a different ionizable lipid, isolating escape rather than uptake as the limiting step.
CNS-directed delivery. A formulation intended for central nervous system exposure is assessed for brain accumulation against a peripheral organ panel, with blood-brain barrier work establishing whether the limitation is barrier penetration or systemic clearance.
Material scope and release criteria
Formulation composition, characterization panel, acceptance criteria, and release specification are defined per project, and material failing specification is reformulated rather than used with the deviation noted. Altogen Labs produces research-grade material for preclinical use; clinical or commercial scale manufacture is not offered and formulations are not represented as GMP material. All in vivo procedures are conducted under active IACUC protocols. GLP standards are applied where a study is formally designated as GLP.
Send payload type, target tissue, and delivery route, or request a quote.