Advantages

With strong project management, adherence to timelines, open communication, and extensive experience, Oakwood takes pride in being a great partner.

Chroniject™ advantages include:

  • ability to scale-up to the commercial scale: products have been successfully scaled-up to 2kg
  • proven lot-to-lot reproducibility: batches have the same characteristics at 10g, 100g and 1000g scales
  • molecule compatibility: works with most small molecules, hormones, peptides and selected proteins or large molecules
  • flexibility in process parameters: can achieve varying desired results, regarding drug load, syringeability, particle size, and more
  • in-vitro/in-vivo correlation (IVIVC): can achieve IVIVC
  • varying durations of release: has achieved a wide range of product durations – from one week to one year
  • easy reconstitution: can be reconstituted with WFI only – no special diluent required
  • IP protection: has expansive protection and opportunities
  • manufacturing: access to Oakwood’s cGMP manufacturing facility

Microsphere Manufacturing

Oakwood can provide manufacturing of commercial batches or clinical trial material of sustained release injectable microsphere products in our cGMP FDA approved aseptic manufacturing facility. We can manufacture engineering, exhibit and validation batches and perform the long term stability studies on-site to ensure a robust process and stability indicating product.

Oakwood can also work with you on formulation development of your small molecule injectable.