Below is a list of some of the recent projects completed by Kymanox.

Process Operations

  • Assisted in compiling information package for transfer of a commercial biologic process to a CMO.
  • Performed screening and selection of drug substance and drug product CMOs for a client's late stage development product.
  • Performed Troubleshooting of a manufacturing process at a CMO of client's late stage development product.
  • Assisted in creating a company-wide risk management policy for a CMO.
  • Managed a project for implementation of Quality Systems at an API manufacturing plant.

Engineering

  • Designed and qualifed Automated Filter Integrity Test Systems for virus removal filters.
  • Designed and engineered the controls for a process water cooler / industrial chiller skid for a pharmaceutical company.
  • Qualified a class 100 facility and all associated equipment for biological manufacturing.

Commissioning and Validation

  • Commissioned and validated Automated In-Line Buffer Dilution (IBD) systems.
  • Commissioned and validated Automated Oligonucleotide Synthesizer systems.
  • Commissioned and validated low and high pressure chromotography (LPLC, HPLC) skid systems.

Software Development

  • Developed CMOLocator™, a world class search-engine for finding Biopharma CMOs.
  • Developed KymaPRO™, a project website solution for biotech, pharmaceuticals and medical device companies.
  • Developed KymaSTORE™, an online warehouse for templates, training packages, and procedures for our clients.
Kymanox | Ideal Knowledge Transfer CMOLocator.com - Find your Bio-CMO KymaSTORE | Downloads for Ideal Knowledge Transfer cGMP Compliant Indelible Ink Pens KymaPRO Project Management Software