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The Alcami Advantage

Catherine Hanley

August 10, 2016

2 Min Read

NEW_LOGO-300x100.jpgAlcami 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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