aseptic filling

Alcami Corporation is a global contract development and manufacturing organization headquartered in North Carolina, U.S., with over 45 years of experience advancing pharmaceuticals and biologics from development to delivery. It provides integrated lab services, drug product manufacturing, packaging and labeling, and cGMP pharma storage and support services.

analytical method developmentcalibrationcGMP storageenvironmental monitoringformulation developmentlyophilizationmicrobiology testingoral solid dose manufacturingpackaging and labelingserialization and aggregationsterile fill-finish manufacturingvalidation

Apiject develops a drug delivery platform that makes injections prefilled. At the core of the Apiject Platform is a Blow-Fill-Seal container adapted for injection use; the single dose container is aseptically filled and combined with a proprietary pen needle hub similar to those used for insulin. The company uses only two primary materials, medical grade plastic resin and stainless steel rolls, to ensure a simple and reliable supply chain.

Blow-Fill-Sealmold designpen needle hub integrationprototype testing

Biowest USA Inc. is a life sciences company specializing in fetal bovine serum (FBS), other animal-derived sera, cell culture media, and salt solutions. The company states over 35 years of serum expertise and operates under ISO 9001:2015 and ISO 13485:2016 registered quality systems, offering full traceability from sourcing to delivery, with USDA-approved serum origins and contract manufacturing/serum filtration services.

blast freezingcontract manufacturingISO Class 5 fillingISO Class 7 filtrationquality control testingserum filtrationtraceability

DCN Dx is an immunoassay CDMO and IVD CRO based in Carlsbad, CA. It provides contract development and manufacturing services, including lateral flow assay development, consumable and cassette design, custom readers, contract manufacturing, aseptic filling, and reagent lyophilization, along with clinical research services such as trial management, site development, biostatistics, data management, and regulatory consulting. Its 35,000+ sq. ft. facility is ISO 13485- and ISO 9001-compliant.

biospecimen collectionsbiostatisticsclinical trial managementconsumable and cassette designcontract manufacturingcustom reader designdata managementELISA developmentlateral flow assay developmentreagent lyophilizationRegulatory consulting