TECHNICAL PROJECT MANAGEMENT
- Facilitated technology transfer for upstream and downstream bulk manufacturing processes.
- Led a worldwide team comprised of six (6) different organizations to commercialize a new drug-device combination product.
- Provided comprehensive technical project management for ISO 9001 Quality Management System certification.
- Implemented a Project Management Office for an organization with no previous project management experience.
For more detailed information, please see our Technical Project Management Case Study.
PROCESS OPERATIONS AND TECHNOLOGY TRANSFER
- 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.
QUALITY AND REGULATORY COMPLIANCE
- Performed a comprehensive on-site GXP gap assessment for Legacy ERP computer systems.
- Created a Quality System framework with the necessary policies and procedures to support the installation and maintenance of a GMP compliant IT network.
- Performed a viral safety assessment.
- Using industry benchmarks, we completed an operational evaluation of all Contract Manufacturing Organization operations available for a proposed vaccine and prepared a comprehensive evaluation report and presentation.
For more detailed information, please see our Quality and Regulatory Compliance Case Study.
VALIDATION AND COMMISSIONING
- Commissioned and validated Automated In-Line Buffer Dilution (IBD) systems.
- Commissioned and validated Automated Oligonucleotide Synthesizer systems.
- Commissioned and validated low and high pressure chromatography (LPLC, HPLC) skid systems.
- Designed and qualified 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.
- Implemented a two-day project management training for professionals within the pharmaceutical, biotechnology, nanotechnology, medical device and green energy industries.
- Developed an extensive, two-day technology transfer program for professionals to ensure technology is transferred right the first time.
- Provided subject matter experts to deliver a training package on current Good Manufacturing Practices (cGMPs).
For more detailed information, please see our Training Case Study.
- 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 has experience in working directly for the US Government as a prime contractor. During the US botulism scare of 2007, Kymanox was hired by FDA to assist with thermal sterilization studies using a TDT Retort System designed and built by a Kymanox employee. Kymanox re-commissioned the idle system and upgraded it to address expanded user requirements which included the addition of a data acquisition system. The project was fast-tracked to meet urgent public safety needs.
Kymanox was hired to create and deliver a comprehensive quality and regulatory training program for flu vaccines based on a 5-year BARDA grant from HHS. This grant was awarded to North Carolina State University's Golden LEAF Biomanufacturing Training and Education Center (BTEC). The program trains vaccine manufacturers from across the globe to use best production practices for the prevention of pandemic viral outbreaks.