Extractable and Leachable Studies

Dedicated to manufacturing parenteral dosage forms, Alcami’s Charleston, South Carolina site supports preclinical production through commercial launch and supply. This US- and EU-compliant and DEA-licensed sterile manufacturing facility is fully integrated with our Wilmington, North Carolina packaging and ...

Specialized to manufacture oral solid dosage (OSD) forms, Alcami’s Wilmington, North Carolina site supports preclinical production through commercial launch and supply. We differentiate ourselves by providing ample problem-solving solutions to your scientific needs.  

Our cGMP manufact...

Study Types-In-use studies (broaching, reconstituted product stability, multi-use container stability)
-Formulation development studies including stress studies
-Photostability (Options I and II)
-Comparator studies
-Thermal cycling/freeze thaw
-Shipping excursion studies
-Long-term stabi...

Method development and phase appropriate validations to support clinical and commercial programsCompendial Testing
Raw Material Testing

Development and optimization of suitable manufacturing processes to support clinical and commercial programs

Support stand along packaging activities or integrated with Alcami's manufacturing capabilities. Can support packaging for clinical kits including kit assembly and commercial packaging.

Fill / Finish services to support biologics.

Formulation development and optimization to support all stages of clinical programs.

Developing and optimizing lyo cycles to support clinical and commercial programs

Tech Transfer and Scale up to support clinical and commercial programs

Alcami offers a fully-integrated analytical method development, method validation, and testing solution with a full complement of advanced analytical and information technologies. From Alcami’s electronic laboratory notebook (ELN) data collection system to its integration with our formulation development, ...

From initial characterization of drug substance to commercial batch release, each phase of your drug product development requires analytical methods to qualify the product for safety, integrity, strength, purity, and quality.  With these critical attributes in mind, Alcami’s biologics analytical devel...

The CDMO will supply expertise in GMP sterile fill-finish manufacturing and controlled-substances

Alcami is equipped and ready to handle study design and execution of food studies to support a variety of oral solid dosage forms, including tablets, capsules, and suspensions. Our subject matter experts have developed and executed studies using infant formula, yogurt, orange juice, apple sauce, smoothies, and a variety of other foods and drinks.

Common high-performance lipids and surfactants were used to improve the dissolution rate of furosemide as a model compound for BCS Class II and Class IV active pharmaceutical ingredients. Furosemide equilibrium solubility was measured throughout an HLB range (1-16) of liquid lipids and surfactants. Furosemide tablets were then manufactured using high shear granulation to absorb the solubilized and suspended furosemide onto microcrystalline cellulose (Avicel PH101). The granulations were then compressed using a rotary tablet press and standard tablet tooling. Finished tablets were analyzed to compare dissolution rates using 0.1 N HCl media and USP Apparatus II. Higher equilibrium solubility yielded increased dissolution rates for furosemide tablets compared to directly compressed furosemide tablets.