Biopolymers

API & Drug Product Development >> Preformulation & Material Science >> Overview

Innovative, non-toxic and fully biodegradable biopolymers, made of hydrophilic (PEG or modified PEG) and lipophilic (PLA, PLGA, CPL) blocks.

Characterizing & Modifying Drug Substances Properties

API & Drug Product Development >> Preformulation & Material Science >> Overview

With expertise in characterizing and modifying a drug substance’s physical, chemical and mechanical properties, our objective is to help you assess and choose the best solid form for progression into animal and human dosing trials.

Drugs Excipient Compatibility Study

API & Drug Product Development >> Preformulation & Material Science >> Excipient Screening

Ascents offerings includes binary or ternary mixtures of API with excipients from various functional categories such as diluents, binders, glidants, disintegrants, lubricants etc., packaging material compatibility studies, selection of excipients for form

Polymers for Vectorization

API & Drug Product Development >> Preformulation & Material Science >> Overview

Alternative to the use of inactivated viruses. Synthetic cationic polymers for nucleic acids (DNA or RNA) and hydrophobic APIs transfer.

Cocrystal Screening

API & Drug Product Development >> Preformulation & Material Science >> Polymorph & Crystal Screening

Comprehensive cocrystal screen and ongoing support for selection

Powder Physical Characterization

API & Drug Product Development >> Preformulation & Material Science >> Particle Size Reduction & Micronization

The formulation development center at Ascent offers physical characterization of powders which includes particle size distribution, bulk and tap density determination, flow properties etc.

Polyamino Acids

API & Drug Product Development >> Preformulation & Material Science >> Overview

2D or 3D biopolymers that generate biodegradable dendrimers used in cosmetics and to vectorize an API or a fluorescent probe.

Enantiomeric Resolution

API & Drug Product Development >> Preformulation & Material Science >> Chiral Resolution Screening

Resolution of enantiomers through crystallization is often a preferred option, favored over costly preparative chromatography during process development and manufacturing. AMRI has the experience to solve your most complex resolution problems through crys

Process Analytical Tech. & Quality by Design

API & Drug Product Development >> Preformulation & Material Science >> Overview

AMRI's PAT approach is consistent with the FDA perspective that quality cannot be tested into products, but should be built in.

Polymorphism

API & Drug Product Development >> Preformulation & Material Science >> Polymorph & Crystal Screening

Characterization studies for your product can be conducted prior to formulation.We specialize in the design and execution of pertinent pre-formulation activities required for successful pharmaceutical product development.