Description
Alcami Corporation is a contract development and manufacturing organisation (CDMO) specialising in tailored solutions for the development, manufacturing, and testing of pharmaceuticals.
Alcami Corporation is a globally recognised CDMO that provides a comprehensive suite of end-to-end services to pharmaceutical and biotechnology companies. Headquartered in the United States, Alcami supports its clients by offering fully integrated solutions across the drug development lifecycle. With facilities strategically located in the US, the company delivers high-quality support for oral solid dose and sterile injectable products, leveraging its expertise in analytical testing, development, and manufacturing. Alcami is committed to fostering innovation, reducing time-to-market, and meeting stringent regulatory requirements, enabling its clients to achieve their goals efficiently and reliably.
Key products and services:
- Drug Development Services:
- Formulation development for oral solid dose and parenteral products.
- Pre-formulation and process optimisation.
- cGMP Manufacturing:
- Production of sterile injectables and oral solid dose forms.
- Customised solutions for small and large-scale manufacturing.
- Analytical Testing Services:
- Stability and release testing.
- Microbiological testing and quality control.
- Regulatory Support:
- Guidance on regulatory compliance and submissions.
- Support for FDA and global regulatory standards.
- Packaging and Labelling:
- Clinical and commercial packaging solutions.
With decades of industry experience and a steadfast commitment to quality and innovation, Alcami Corporation continues to position itself as a trusted partner for pharmaceutical and biotech companies worldwide. By offering flexible, customer-centric solutions, Alcami ensures that its clients receive the expertise and resources they need to bring life-changing therapies to patients.
Manufacturing Information
Capabilities
- Accelerated Stability Studies
- Analytical Services
- Animal Health
- Anti-Counterfeiting
- Antibody-Drug Conjugates
- Asceptic Fill-Finish
- Assay Development
- Bioanalytical Services
- Bioavailability Studies
- Biological Testing
- Biologics
- Biosimilars
- Blister
- Calibration
- Capsule
- Cell and Gene Therapy
- Chemical Analysis
- Chemistry (CMC)
- Chiral Separations
- Chromatography
- Clean Room Services
- Clinical Trial Materials
- Clinical Trials
- Coating & Lamination
- Cold Form
- Comparator Drugs
- Contract Development and Manufacturing (CDMO)
- Controlled Release
- Controlled Substances
- Creams & Ointments
- Design & Testing
- Dosage Form Development
- Dose Form
- Drug Delivery Devices
- Electronic Data Management
- Encapsulation
- Endotoxin Testing & Removal
- Environmental Monitoring
- Excipients
- Feasibility Studies
- Filling
- Filtration
- Finished Dosage Forms
- Fluid Bed Processing
- Forced Degradation Studies
- Formulation Development
- Generics
- Glass
- Granulation
- ICH
- ICP
- In Vitro Testing
- IND/NDA Submissions
- Injectables
- Labelling
- Liquids
- Lot Release Testing
- Lyophilization
- Mass Spectrometry
- Materials Analysis
- Micro FT-IR Analysis
- Microbiological Testing
- Microencapsulation
- Micronization
- Microscopic Analysis
- Mixing & Blending
- Non Sterile Dosage
- Oral Drug Delivery
- OTC
- Packaging
- Parenterals
- Parenterals Development
- Particle Size Analysis
- Photostability
- Physical Testing
- Pilot-Scale Filling
- Powders
- Preclinical Testing
- Preformulation
- Process Characterization
- Process Development
- Process Validation Studies
- Project Management
- Quality QA/QC
- Raw Materials
- Raw Materials Analysis
- Research & Development
- RFID
- Samples
- Scale-Up
- Serialization
- Shipping
- Solid Dosage
- Solutions & Suspensions
- Spray Drying
- Stability Studies
- Sterile
- Sterile Filling
- Sterility Testing
- Sterilization
- Storage
- Supply Chain & Logistics
- Supply Chain Management
- Sustained Release
- Sustained Release Delivery Systems
- Syringe
- Tablet Coating
- Tablets
- Testing
- Thermogravimetric Analysis
- Trace Metal Analysis
- UV-VIS Spectrophotometer Analysis
- Vaccines
- Validation
- Vials
- Water Testing
- Wet Chemical Analysis