Manufacturing differences between biopharmaceuticals and low molecular weight drugs. Basant Sharma, PhD Vice President, Pharmaceutical Technology Centocor Raritan, New Jersey, USA. 1. September 2005. Manufacturing low molecular weight drugs.
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Manufacturing differences between biopharmaceuticals and low molecular weight drugs
Basant Sharma, PhD
Vice President, Pharmaceutical Technology
Raritan, New Jersey, USA
Low molecular weight drugs are made by adding and mixing together known chemicals and reagents, in a series of controlled and predictable chemical reactions
This is organic chemistry
Biopharmaceuticals are made by harvesting the proteins that are produced and secreted by specially genetically engineered living cells
This is genetic engineering
These differences clearly apply to biosimilars as well as to original biopharmaceuticals
Each of these stages can have a major influence on the characteristics of the end product
The exact DNA sequence and the type of host cell used will significantly influence the characteristics of the product
A cell bank is then established, using an iterative and elaborate cell screening and selection process, yielding a unique master cell bank
No two master cell banks are exactly alike
The ‘engineered’ cells are then cultured on a large scale under strictly defined growth conditions that optimize cellular production and secretion of the desired protein
Cell bank frozen vial recovery
The conditions under which cells are cultured can affect the nature of the end product
Large cost implications
Any change in the purification process can affect the clinical characteristics of the product
These tests remain limited in their ability to detect all product characteristics that may affect clinical efficacy and safety
The components of the formulation, and the process used, can significantly affect the product’s behaviour in patients
Poor adherence to (cold) storage requirements can affect clinical efficacy and safety
Crommelin DJA. EJHP 2003;1:73-94.
Manufacturing biopharmaceuticals is a complex, high-tech, and time-consuming process
‘The process is the product’
How similar is similar enough?