Lyophilization Process Development

The art of developing efficient and robust freeze drying cycles which also work under conditions of large scale manufacturing.

Pilot scale lyophilization cycle development adapted to GMP manufacturing of all kinds of freeze-dried drug products.

Lyophilization Cycle Development und Technology Transfer

We take new paths in lyo-cycle design to quickly and efficiently generate a dry and elegant lyophilizate without compromising process safety and stability of the product.

Our experience in lyophilization process development covers freeze-drying of:

  • formulations in vials, (dual chamber) syringes and bulk trays
  • containers in nest&tub configuration
  • formulations containing organic solvents
  • formulations of highly concentrated proteins
  • ADCs and other cytotoxic drugs
  • live virus vaccines

Three high-end HOF pilot freeze dryers, adaptable to any specific conditions of large scale manufacturing, are implemented in dedicated labs for the rational design of reliable and cost-effective freeze-drying cycles. After physicochemical characterization of the final drug product formulation, we define the ideal freezing (including own technologies for controlled nucleation), sublimation and drying parameters and run an in-depth analysis of lyophilizates by own scanning electron microscopy (SEM).

We determine the critical lyophilization parameters and modulate those by means of robustness studies to explore the design space for the process (Quality-by-Design). Our goal is a technology transfer to clinical / commercial drug product manufacturing without defective batches.

Process Mock-up Studies and Aseptic Manufacturing of Preclinical Samples

Our pilot labs are equipped with all relevant process technologies which are also used in commercial aseptic manufacturing of final drug products. During pharmaceutical process development we take specific formulation characteristics into account like viscosity, surface incompatibilities, shear sensitivity and explore mixing, filtration, filling and freeze-drying operations under real conditions to define process specifications.

By aseptic manufacturing under clean bench conditions using sterile containers / equipment and sterile filtered drug solutions in combination with aseptic freeze drying, we can provide samples for stability and preclinical testing with a quality equaling that of the later clinical or commercial product.

Partners

ProJect Pharmaceutics uses pilot freezed dryers from Hof Sonderanlagenbau, technology leader and high quality manufacturer of freeze drying systems. Experts from both firms are in mutual exchange of experience to promote lyophilization technology.

ProJect Pharmaceutics uses Teclen Lyoprotect® systems to mitigate the contamination risk in freeze-drying.

ProJect Pharmaceutics and LYOCONTRACT teamed up to provide the pharmaceutical industry with high quality parenterals. LYOCONTRACT is a state-of-the-art pharmaceutical manufacturing site with the capabilities of producing liquid and freeze-dried parenteral drugs from clinical to large scale commercial scale.