Lyophilisation Facilitates Market Entry for Increasing Number of Injectables
For many pharmaceutical or biotechnology products, lyophilisation is essential to maintain the function and integrity of the drug or biomolecule. In 2012, there were over 130 pharmaceutical products on the market that required lyophilisation processing with significantly more under clinical and pre-clinical development. The increasing demand for injectable lyophilised drugs is driven by the entry of new products and technologies, in particular those for novel oncology treatments.
Without the use of lyophilisation, it is estimated that 60% of biotherapeutics — including peptides, recombinant proteins, antibodies and antibody drug conjugates (ADCs) — could not be made commercially viable. The freeze-drying process has become increasingly more efficient in recent years, making it easier to use, more cost-effective and extremely good at maintaining product integrity.
Symbiosis, a small-scale contract manufacturer of injectable pharmaceuticals for use in clinical trials, has two LYO-5 lyophilisers supplied by pharmaceutical freeze-dryer manufacturer Tofflon. These freeze dryers are manufactured according to cGMP guidelines and FDA recommendations, under an ISO 9001 Quality Assurance System. Each lyophiliser is located in a fully separated cleanroom and supports manufacturing for conventional pharmaceuticals and cytotoxics/highly potent compounds.
The optimal size of the Symbiosis lyophilisers were chosen to support manufacturing for phase I and II clinical trials. The large shelf area (5.4 m2) allows small to medium scale batches to be undertaken in one lyophilisation cycle with the resulting advantage to customers of increased speed and lower post-lyophilisation testing costs. The lyophilisers can support a full range of vial sizes from 2 to 100 ml. The flexibility also allows Symbiosis to support manufacture for small batches in the range of 100 vials. For bulk lyophilisation, Symbiosis has validated procedures in place for 45l batch sizes, with the possibility of increasing to 100 l batch size.
Symbiosis has experience in the lyophilisation of small molecules, peptides, antibodies, cytotoxics and ADCs. In addition, through its partners, the company can help with lyophilisation cycle development, optimisation and formulation development throughout all stages of the product development lifecycle.
Symbiosis Pharmaceutical Services, +44 1786 220 000, enquiries@symbiois-pharma.com, www.symbiosis-pharma.com.