DRUG DEVELOPMENT PROJECT MANAGEMENT

Kalon utilizes a proven and active communicative approach for the management of all development and manufacturing projects. Our project management systems, processes, and experience in developing collaborative relationships allow us to ensure successful delivery.

Our open communication philosophy allows a full understanding of the progress of the program at every stage. This includes setting project goals, objectives, and deliverables that are maintained along with the agreed timelines, yet flexible when needed.

GMP MANUFACTURING CAPABILITIES

Kalon operates the NCTM facility which includes 110,000 sf of cGMP space. Up to 20 mobile clean rooms (MCRs) are operated in the cGMP space. Kalon works with its clients at any stage in the drug discovery process and will map out the steps for accelerated drug development including necessary process development and clinical trial scale-up. Alternatively, Kalon clients may wish to simply have access to dedicated MCRs for their own development or production. Additional services include:

  • Multiple processing systems that include single-use technologies
  • Cell culture and microbial expression platforms with media optimization and screening study capabilities
  • Process scale-up to support Phase I through Phase III “run in”
  • Technical consultation, process development for both upstream and downstream processing
  • Drug product formulation development and aseptic filling
  • Cell line optimization including re-cloning and amplification
  • Medium optimization studies and adapting cells to protein-free medium
  • Transfection, cloning, and selection to create new cell lines
  • Analytical method transfers, development, and qualification
  • “Core” services such as quality assurance, quality control, inventory control, shipping and receiving, security

REGULATORY ASSISTANCE

Kalon provides regulatory support services by leveraging experienced personnel who assure deliverables meet regulatory guidance standards. A wide and flexible range of services is offered and tailored to each project, including:

  • Strategic planning and consultation
  • Submission of regulatory IND document in the US
  • CMS process development and manufacturing documentation