& Associates
Client Services
client services
client list
isolators
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Agalloco & Associates Office Address: Mailing Address: |
Isolators
Abbott Laboratories
- North Chicago, IL - assistance in the qualification, cycle development and validation of a high speed filling line.
Alkermes Inc.
- Cambridge, MA & Wilmington, OH - design concepts for clinical supply production of lyophilized biological product, design concepts for sterile bulk production; assistance with sterilization validation.
Allergan
- Irvine, CA - conceptual design of isolator based filling system.
Alliance Pharmaceuticals
- San Diego, CA - conceptual design for sterile powder manufacturing technology.
Amersham
- South Plainfield, NJ - conceptual design and validation of an isolator based radiopharmaceutical manufacturing and testing capability.
Bigmar Pharmaceuticals
- Lugano, Switzerland - master planning and consultation for cytotoxic drug lyophilized fill line and formulation area, assistance in regulatory interface.
Biomira USA
- Cranbury, NJ - and consultation for clinical filling of biological product.
Ethicon
- San Angelo, TX - design of environmental monitoring program for medical device manufacturing system, design of microbial sampling system.
Fort Dodge Animal Health
- Princeton, NJ - conceptual design for sterile solid dosage form.
Genetics Therapy
- Gaithersburg, MD - conceptual design for gene therapy production.
La Calhene
- Rush City, MN - development of vendor documentation packages.
Life Technologies
- Grand Island, NY - conceptual design for application in high speed liquid filling.
McGaw
- Irvine, CA - design review, consultation and validation services, sterilization system, and regulatory assistance for aseptic filled injectable products.
Noramco
- Albany, GA - application to bulk pharmaceutical chemicals facilities for containment and microbial control.
Orfaquim
- Cuautitlan, Mexico - design concepts and consultation for sterile bulk operations.
Survival Technology
- St. Louis, MO - validation support for liquid filling system.
Therics, Inc.
- Princeton, NJ - conceptual design and validation support for aseptic device. manufacturing system.
Transkaryotic Therapies
- Cambridge, MA - conceptual design for applications in gene therapy.
Walker Stainless
- New Lisbon, WI - development of vendor documentation packages.
Additional Activities
Sterility Test Systems
- multiple locations - assistance has been provided in the validation of sterility test systems for Alcon, Allergan, Alkermes, Amersham, BioReliance, Ethicon, G.C. Hanford, Hoffmann-La Roche [2 different systems], Pfizer, Schering, and Syntex.
Training
- multiple locations - provide in-house training to individual firms and provide open courses via PDA / IIR.