September 30, 2016 6:59 PM ET

Life Sciences Tools and Services

Company Overview of Alcami Corporation

Company Overview

Alcami Corporation provides contract pharmaceutical development and manufacturing services. It offers pharmaceutical development and commercialization services in the areas of early-phase clinical trial material formulation development, analytical method development and validation, biopharmaceutical analytical development and validation, stability storage and testing, clinical trial material manufacturing, oral and solid-dose manufacturing, and sterile/aseptic process manufacturing aspects, as well as packaging, labeling, and distribution services. The company provides analytical testing services, such as chemistry, microbiology, and stability services; solid oral dose and parenteral manufac...

2320 Scientific Park Drive

Wilmington, NC 28405

United States

Phone:

910-254-7000

Fax:

910-815-2300

Key Executives for Alcami Corporation

Chief Executive Officer
Age: 51
Founder, Non-Executive Chairman and Scientific Advisor
Chief Financial Officer
Chief Operating Officer
President of Cml Europe
Compensation as of Fiscal Year 2016.

Alcami Corporation Key Developments

Alcami Announces New Highly Potent API Capabilities and Capacity in Germantown, WI

Alcami announced its plans to expand capabilities for development and manufacturing of Active Pharmaceutical Ingredients (APIs) at its Germantown, WI facility. Alcami plans to invest in 2016 and 2017 toward the enhancement of new and existing kilo labs to introduce the development and manufacturing of highly potent APIs. The two new fully qualified cGMP Highly Potent API (HPAPI) production suites will focus on primary containment technologies with engineering controls designed to meet the established Occupational Exposure Limit (OEL) of minimally 0.03 µg/m3 (SafeBridge® Category 3). The 5,000 square foot renovation will be operational by first quarter, 2017. The newly designed space will include up to 150L reactor scale with cryogenic capabilities to service a wide range of complex chemistries. These advancements position Alcami to meet the demands of a growing highly potent API market. Coupled with Alcami's established presence in the potent Drug Product market, this investment strengthens an industry leading end-to-end offering. These advancements follow operational and technology enhancements across development, clinical and commercial manufacturing to increase production capacity by 50%. This positions Alcami's global API operations (Germantown, WI and Weert, The Netherlands) to meet the increasing demand of new clinical candidates, of which greater than 70% originate from small and mid-size pharma and biotech. The Germantown, WI facility recently completed an FDA General Inspection that resulted in zero 483 observations. This result demonstrates Alcami's commitment to quality and regulatory compliance.

Alcami Announces Enhanced Laboratory Services in Wilmington, NC Headquarters

Alcami announced that it has taken major steps in upgrading its laboratory service capabilities to meet market and client demands. Approximately 5,000 square feet of the current Technology Center located in Wilmington, NC will be converted to newly reconstructed laboratory space. The newly reconstructed laboratory space will be dedicated to dissolution testing (Apparatus I, II, III, IV and intrinsic dissolution), Karl Fischer testing (humidity controlled room), microbiology, and formulations development. The new space adds 15% additional capacity for dissolution as well as a new capability of a UV sampling automation. Further laboratory expansion is expected with construction of a new building, which was announced in Nov. 2015. The new building will provide increased capacity and flexibility to meet client needs. Efficiency efforts following Lean Six Sigma 5S and Lean principles will be paired with this physical expansion. One of five laboratory spaces has already completed redesign/process flow optimization and the remaining labs will be completed by end of 2016.

Alcami Corporation Presents at 2016 BIO International Convention, Jun-08-2016 01:45 PM

Alcami Corporation Presents at 2016 BIO International Convention, Jun-08-2016 01:45 PM. Venue: Moscone Center, San Francisco, California, United States.

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