IRISYS EXPANDS GMP MANUFACTURING OF STERILE DRUG PRODUCTS FOR CLINICAL AND COMMERCIAL SUPPLY
Pharmaceutical formulations have become more sophisticated over time and, as a response, so has the pharmaceutical manufacturing process. IRISYS is currently meeting its clients pharmaceutical manufacturing needs for clinical trial materials for phases I through III and smaller scale commercial manufacturing projects, but in early 2021 IRISYS will have the capacity to meet clients’ additional needs of larger batches of sterile injectables.
“As of the first quarter 2021 IRISYS is adding a technologically advanced commercial injectable vial filling and lyophilization system, built by SP Industries. We are now able to take orders for automated sterile GMP filling of 2 mL up to 50 mL vials. We also will have large scale capacity to lyophilize that entire range of vial sizes, for example, up to about 7,500 X 10R vials per batch.” CEO Robert Giannini
Why is Lyophilization (freeze-drying) for Stability Important?
Lyophilization has been around since 1890 and was originally used in the food industry. Lyophilization is the process by which water is removed from a product after it is frozen and placed under a vacuum, allowing the ice to change directly from solid to vapor without passing through a liquid phase. Products can be lyophilized directly in vials, or in trays with later packaging of the powdered material. Lyophilized powders and can be easily stored and shipped. Storage in the solid state at controlled moisture content can provide a significant stability advantage for active pharmaceutical ingredients.
“Pharmaceutical companies found lyophilization increased shelf-life and stability of their drugs.” President Robert Giannini
Lyophilization can benefit many types of active pharmaceutical ingredients and formulas including:
Table 1: Global Sales of Top 10 Lyophilized Drug Products
|Product Name||API||Indication||Owner||Estimated 2018 Product Sales|
|Keytruda||Pembrolizumab||Cancer||Merck and Co.||$7.2B|
|Remicade||Infliximab||Rheumatoid Arthritis, Crohn’s Disease||Janssen Biotech||$6.4B|
|Carimune NF||Immunoglobulin||Immunodeficiency||CSL Behring||$3.3B|
|Orencia||Abatacept||Rheumatoid Arthritis||Bristol-Myers Squibb||$2.9B|
|Cosentyx||Secukinumab||Plaque Psoriasis||Novartis AG||$2.8B|
|Avonex||Interferon beta-1a||Relapsing MS||Biogen||$2.4B|
Many approved lyophilized drug products are biologics—proteins, peptides, nucleic acids, and other substances derived from or based on naturally-occurring compounds. It is estimated that over 60% of biologics on the market today would not be possible without lyophilization, and market demand for lyophilization technology will only increase as more biosimilars and novel
“IRISYS is dedicated to achieving the highest level of cGMP in the field.”