You may have a product with unique challenges, but LSNE can guide you to success. Whether you have a small molecule with solubility issues or a labile molecule that is stable as a liquid presentation for only a few hours. With efficiency and cost savings in mind, we focus on developing processes that are scalable, reproducible, and commercially robust. By leveraging over 23 years of experience in aseptic contract manufacturing, we have the flexibility to perform individual experiments or craft a customized development program for your product.
Poor Solubility or Stability?
We will start by performing a pre-formulation study or by leveraging existing data you may have to understand the key physical characteristics of your product. With this understanding of the chemical properties of the molecule, we will strategically plan and execute your development program. Key studies of your development program may include:
- In-use (Bulk) stability
- Order of addition
- pH ranging
- Material compatibility
- Filter adsorption
- Tonicity (SQ/IM)
Whether you are developing a liquid or lyophilized dosage form, we understand speed and flexibility are critical to the success of your development program. We have the ability to screen multiple experimental formulations in parallel to expedite the formulation development phase of your program and get you to the aseptic fill finish steps.
LSNE will evaluate the solubility and stability using a variety of analytical methods at a pH range that is suitable for the intended route of administration for your product. Liquid presentations are subjected to key stressors to drive degradation during short-term R&D stability and tested at frequent time points to determine the optimal formulation for your product.
Lyophilization Cycle Development
If you are developing a lyophilized presentation, we have the ability to screen formulations with a wide variety of cryoprotectants and bulking agents, and accelerate the overall timeline of your lyophilization cycle development program. With multiple R&D freeze dryers of the same make and model, we can split the formulated material into multiple lyophilizers and perform a side-by-side evaluation. If you have a tight timeline, talk to us, LSNE is the development partner you need to get things done.