Client Services
Clients
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.

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