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Developing a Lyophilized Drug Product? Don’t Forget the Diluent

Developing a Lyophilized Drug Product? Don’t Forget the Diluent

Medium: Contract Pharma
Author: Daniela Guttmann, Product & Service Manager & Dr. Karin Kottig Manager Contract Service Analytics

The world’s biologics market is growing fast. It is expected that the market will reach $250 billion in 2024, nearly doubling from where it is today. The numbers of parenteral biologics filled in lyophilized vials are also growing rapidly, largely as a result of the complexity of biologics as well as issues that pertain to stability of liquid formulations. In parallel, costs associated with new drug development have also continued to grow, nearly doubling within the last decade. Never before has the investment in diluents been more critical.

Vials and syringes comprise the two most common forms of diluent programs. Because kits with diluent vials are more complex, comprised of two vials, two syringes and three needles, the full process up until injection can take as long as 25 minutes. Additionally, there is a risk of incorrect dosing and needle stick injuries to the health care professional and patient alike. An injection kit using a diluent syringe instead of a diluent vial involves two syringes and one vial with the lyophilized drug, and only one needle for the injection. This kit improves compliance and lowers the risk of potential dosing errors or contamination. Fewer steps with only one needle for the injection also means there is a reduced risk of injury from needle sticks and an increased comfort for patients and health care professionals. Prefilled diluent syringes can also enable opportunities for product differentiation in the market.

Learn more about advantages and disadvantages of the most common diluent programs, factors to consider when choosing a program and benefit from an illustrative case study.   

Read the full article online:

Developing a Lyophilized Drug Product? Don’t Forget the Diluent


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