August 10, 2016
Sponsored Content
Alcami specializes in all phases of pharmaceutical development — from critical preformulation studies to commercial product life-cycle management. Over the past 30 years, Alcami has supported more than 500 investigational new drug (IND) filings and over 50 new drug applications (NDA), abbreviated new drug applications (ANDA), and new animal drug applications (NADA). Our fully integrated, comprehensive development services are well established and ready to help our clients get the most out of their portfolios.
Principal Offerings
Formulations to improve pharmacokinetics
Reduced development timelines by as much as 10%, lowering costs by as much as 20%
Online services system for compendial raw materials testing with release in 10 business days or less
8,200 ft3 of stability storage with full ICH and custom conditions
Strong compliance record and excellent audit history
Facilities compliant with US Food and Drug Administration (FDA), Medicines and Healthcare Products Regulatory Agency (MHRA), and European Medicines Agency (EMA)
Developed formulations, analytical methods, and manufactured products in more than 600 US and EU regulatory filings
Powder-in-capsule using Xcelodose® 600S and powder-in-bottle using Autodose™
Batch sizes from a few hundred to 30,000 vials
DEA compliance for controlled substances
Distribution to clinical trials anywhere in the world
Drug Development
Alcami’s analytical services ensures that robust methods can be transferred throughout the world:
Analytical development and validation for small-molecule, biotechnology, and large molecules
Physical chemistry and material characterization
Stability storage and analysis
Compendial raw materials testing.
Alcami’s formulation services have proven know-how and timeliness for every development project:
More than 300 compounds formulated over 30-plus years
Oral solid dose development
Parenteral (both liquid and lyophilized) formulation development
Oral drug delivery technologies
Manufacturing and Packaging
API Manufacturing
Kilograms to multitons CGMP production
Up to 2,000-gallon scale
State-of-the-art isolation and containment equipment
Scalability across all sites driven by robust process development, design of equipment system modeling, engineered solutions, and technology alignment
CGMP kilo laboratory up to 2,000-gallon reactor suites
Expert level request for qualification (RFQ) assessment.
Drug Product — Oral Solid Dose
Batch sizes ranging from 200 g of active pharmaceutical ingredient (API) for phase 1 powder in capsules on the Xcelodose to large-scale commercial tablet batches up to 650 kg
Potent compound manufacturing
Dry blends, roller compaction, wet granulation (low/high shear and spray), film coating, and tablet and capsule manufacturing
Flex suites for novel manufacturing processes.
Drug Products — Parenteral
Sterile products for small molecules and biotechnology, including proteins, peptides, monoclonal antibodies, and other large molecules
Batch sizes from 220 mL to 340 L
Aseptic filtration/filling, terminal sterilization, and lyophilization.
Packaging Services
Custom packaging, labeling, and kitting for clinical trial supplies
Special packaging needs — square bottles, blisters, cartons, vials, ancillary supplies, concomitant medications, cases, and cachets
Temperature- and humidity-controlled storage
Temperature monitoring and validated shipment configurations.
Support Services
Our in-house expertise in regulatory affairs and quality assurance can support your projects, inspections, and filings:
Quality assurance
Regulatory affairs
Stability management.
Catherine Hanley is director of marketing at Alcami, 2320 Scientific Park Drive Wilmington, NC 28405, 1-800-575-4224; [email protected]; www.alcaminow.com.
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