Lyophilization Cycle Development

Process development

Pilot scale lyophilization cycle development adapted to GMP manufacturing of freeze dried drug products, for aqueous solutions and formulations containing organic solvents and polymers.

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

Our pilot lab is equipped with all relevant process technologies which are also used in commercial aseptic manufacturing of drug products. During pharmaceutical process development we take specific characteristics of the formulation for fill-finish like viscosity, surface incompatibilities, shear sensitivity into account. We explore mixing, filtration, filling and freeze-drying operations under real conditions to identify critical process parameters by process analytical technologies (PAT) and to define process specifications. Samples for stability and preclinical testing can be provided with a quality equaling that of the later commercial product.

Lyophilization cycle development
Freeze drying is one of the most cost-intensive manufacturing processes in the pharmaceutical industry. We take new paths in program design to quickly and efficiently generate a dry and elegant lyophilizate without compromising process security and stability of the product. Our experience in lyophilization process development covers also the freeze drying of formulations containing organic solvents and polymers. One of our pilot freeze dryers is implemented in our dedicated cyto-lab enabeling us to develop lyo-cycles for ADCs and other cytotoxic drug molecules.

A freeze-drying cycle is only fully developed when it runs reproducibly in GMP manufacturing. We do not develop laboratory processes, but define process specifications for pharmaceutical production. We analyze the process data of the production freeze dryer and adapt our advanced and highly flexible pilot freeze dryers to these conditions. We determine by PAT 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 without defective batches.

Technology Transfer and scale-up
Technology transfer and up-scaling are the processes by which formulations and fill-and–finish techniques developed in the laboratory are brought into large scale GMP manufacturing. If required, we select and qualify the most suitable contract manufacturer for our customers drug product and manage the technology transfer to GMP manufacturing.

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