Mission: Freeze-Drying Control

Biologic drugs have shown great promise in curing many life changing diseases, even some that were once thought incurable. However, due to the sensitive nature of biological material it requires specialized development and manufacturing processes. Stabilization by lyophilization is attractive to retain the product’s biological activity, structural integrity and homogenous quality, all of which are crucial to the success of the product. This white paper describes the challenges associated with lyophilization of biologic drug products. Using a Quality by Design (QbD) approach with SP Scientific’s Line of Sight™ (LoS) suite of technologies that provide a data-rich environment, many of these challenges can be overcome. In particular, scaling-up of lyophilization from early development to full commercialization can be streamlined through the use of scalable technologies available within the LoS portfolio. Companies working on biologics need robust processes with proven data to deliver successful products.

Download the Document

    * denotes a required field

    Please fill out the information below. If you are already registered, and this information will be filled out for you.

  • Please enter your first and last name.

  • Please enter the name of the company or institution you work at.

  • Please enter your mailing address.

  • Please enter the e-mail address you would like to be contacted at.

  • Please enter the phone number you would like to be contacted at.

    • By submitting this form, you consent to American Pharmaceutical Review storing your email address and contact information and transmitting your contact information to the content sponsor. You may request to be removed at any time.