PDS Italy offers expertise in formulation, cycle optimization, and CTM manufacture of lyophilized products in pre-clinical stages through to scale-up and registration batches. The PDS team of scientists at Ferentino Operations is dedicated entirely to the development of lyophilized products.
PDS Italy operates three dedicated development lyophilization units ranging in size from 0.2 m2 to 0.8 m2. Our scientists have experience in the development of lyophilized dosage forms for conventional small molecules through to complex large molecule products such as MAbs, proteins and peptides. The development of large molecule products is supported by in-house bioanalytical capabilities such as:
- Reducing/non-reducing Sodium Dodecyl Sulfate Polyacrylamide Gel Electrophoresis (SDS-PAGE)
- Isoelectric Focusing
- Western Blotting
- UV Spectropscopy
- Mass Spectrometry
- HPLC Methods – Size Exclusion, Ion Exchange, Reversed Phase
- Enzyme-linked Immunosorbent Assay (ELISA)
- Capillary Electrophoresis
Having this wide range of analytical tools at the disposal of our experienced scientists helps us to deliver efficient development solutions for a full range of lyophilized products.