Ensuring Your Product's Safety, Efficacy, and Timely Project Completion.
Microbiological testing is an important factor in ensuring your product’s safety, efficacy, and timely project completion. At Alcami, we combine decades of microbiological expertise, developed from serving the biotech, pharmaceutical, and medical device industries, to provide the most current and effective methodologies for developing our customers’ biologic and biopharmaceutical products.
Alcami’s core strengths include non-sterile product evaluation, sterile product testing, tests for specified organisms, microbial enumeration tests, preservative effectiveness, antibiotic potency assays, environmental monitoring support, and disinfectant efficacy/qualification studies.
Your Timeline is Our Timeline.
Alcami strives to set the standard for excellence in the contract development and manufacturing organization (CDMO) space. Our latest initiative for excellence is critical in any phase of the drug development process: timelines.
Alcami offers a full range of compendial, compliant microbiological testing per the USP, EP/PhEur, JP, BP:
- Analysis of non-sterile products
- Microbial assay
- Microbial limits test
- Microbial enumeration and validation
- Tests for specified organisms
- Microbial identification (Genotypic and Phenotypic)
- Water activity testing
- Sterile product testing
- Method suitability
- Sterility testing by membrane filtration and direct transfer with barrier isolator technology
- Antimicrobial effectiveness (preservative efficacy) validation and testing
- Bacterial endotoxin testing
- Inhibition/enhancement studies
- Gel clot Limulus Amebocyte Lysate (LAL) assay
- Kinetic chromogenic LAL assay
- Turbidimetric LAL assay
- Environmental monitoring and facility support
- Disinfectant efficacy/disinfectant qualification studies
- Incubation and enumeration of environmental monitoring plates
- Pharmaceutical water system validation and routine testing (WFI, purified water, clean steam)
- Biological indicator total viable spore count, purity, and post-exposure testing
- Container closure integrity testing (microbial ingress and dye immersion)
- Microbial identification by MIDI, VITEK II, and MicroSeq
- Strain typing by DiversiLab rep-PCR system