Agalloco & Associates
P.O. Box 899
Belle Mead, NJ 08502
- North Chicago, IL - assistance in the qualification, cycle development
and validation of a high speed filling line.
- Cambridge, MA & Wilmington, OH - design concepts for clinical
supply production of lyophilized biological product, design concepts
for sterile bulk production; assistance with sterilization validation.
- Irvine, CA - conceptual design of isolator based filling system.
- San Diego, CA - conceptual design for sterile powder manufacturing
- South Plainfield, NJ - conceptual design and validation of an isolator
based radiopharmaceutical manufacturing and testing capability.
- Lugano, Switzerland - master planning and consultation for cytotoxic
drug lyophilized fill line and formulation area, assistance in regulatory
- Cranbury, NJ - and consultation for clinical filling of biological
- San Angelo, TX - design of environmental monitoring program for
medical device manufacturing system, design of microbial sampling
Fort Dodge Animal Health
- Princeton, NJ - conceptual design for sterile solid dosage form.
- Gaithersburg, MD - conceptual design for gene therapy production.
- Rush City, MN - development of vendor documentation packages.
- Grand Island, NY - conceptual design for application in high speed
- Irvine, CA - design review, consultation and validation services,
sterilization system, and regulatory assistance for aseptic filled
- Albany, GA - application to bulk pharmaceutical chemicals facilities
for containment and microbial control.
- Cuautitlan, Mexico - design concepts and consultation for sterile
- St. Louis, MO - validation support for liquid filling system.
- Princeton, NJ - conceptual design and validation support for aseptic
device. manufacturing system.
- Cambridge, MA - conceptual design for applications in gene therapy.
- New Lisbon, WI - development of vendor documentation packages.
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.
- multiple locations - provide in-house training to individual firms
and provide open courses via PDA / IIR.