Abstract：
:Liquid formulation of therapeutic proteins is a maturing technology. Demand for products that are easy to use in the clinic or that are amenable to self-administration make a ready to use liquid formulation desirable. Most modern liquid formulations have a simple composition; comprising a buffer, a tonicity modifier, a surfactant, sometimes a stabiliser, the therapeutic protein and water. Recent formulations of monoclonal antibodies often use histidine or acetate as the buffer, sucrose or trehalose as the tonicity modifier and polysorbate 20 or 80 as the surfactant with a pH of 5.7 +/- 0.4. The mechanisms for the behaviour of excipients is still debated by academics so formulation design is still a black art. Fortunately, a statistical approach like design of experiment is suitable for formulation development and has been successful when combined with accelerated stability experimentation. The development of prefilled syringes and pens has added low viscosity and shear resistance to the quality attributes for a successful formulation. To achieve patient compliance for self-administration, formulations that cause minimal pain and tissue damage is also desirable.
journal_name
Biotechnol Advjournal_title
Biotechnology advancesauthors
Falconer RJdoi
10.1016/j.biotechadv.2019.06.011subject
Has Abstractpub_date
2019-11-15 00:00:00pages
107412issue
7eissn
0734-9750issn
1873-1899pii
S0734-9750(19)30102-8journal_volume
37pub_type
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