Climate change & greening of pharmaceutical manufacturing
Dr Girish Malhotra of Epcot International looks at what it will take to make the pharmaceutical industry green
In a recent blog on API manufacturing , I wrote : “ Minimising / reducing the ‘ E-factor ’ is a multiple win . It will lower manufacturing costs , protect public health and the environment , and also lower the drug costs to the public . We need to ask ourselves “ What would be our legacy for the generations to come ?” Let us write it .” 1 This was not a criticism of the current landscape but a reality check of the pathways the pharmaceuticals industry , the largest greenhouse gas emitter per kilo , has to take to minimise or eliminate and achieve net zero emissions . It is not going to be easy , due to many internal and external challenges .
Climate change
Recently a few branded drug pharmaceutical companies have set out their plans to achieve net zero . 2 , 3 The emphasis of most is on energy conservation . Other than Amgen , no companies have said anything about their API manufacturing and formulation practices . In my view , these programmes have not even touched the tip of the iceberg . Pharma is the biggest contributor to the emission factor and generics have not publicly presented any plans for reduction of global warming . Most emissions come from solvent use , even when they are recycled and reused . Three elements must act in unison if anything meaningful has to happen in pharma ’ s effort for reduction of global warming : the current business model , manufacturing technologies , and the US FDA and other regulators . Each
Patients
Milligrams
Table 1 – Relationship between API & tablets
Table 2 - Formulator drug selling price ($/ kg ) & patient purchase price
will face challenges and the question is how they will cooperate . Before we review the pathways to minimise or reduce pharma ’ s E-factor , we need to review how we got to this stage . This applies to both branded and generic drugs . Biotech drugs are new to the landscape but their process manufacturing execution is similar to that of small molecules . Some may disagree but the same engineering principles apply to their manufacture also .
# of Tablets / person / yr .
API , Kilograms / year
Tablets / yr .
50,000,000 1 365 18,250 18,250,000,000 50,000,000 50 365 912,500 18,250,000,000
Drug Metformin HCl Ciprofloxacin Levothyroxine Atorvastatin API cost $/ kg 4.00 25.00 4400.00 310.00 Inert excipients $/ kg (@ 40 % API cost ) Conversion cost , $/ kg (@ 40 % API cost )
1.60 10.00 1760.00 124.00
1.60 10.00 1760.00 124.00
Profit (@ 40 % above ) 2.88 18.00 3168.00 223.20 Total , $/ kg 10.08 63.00 11088.00 781.20
Average dose 500 mg 500 mg
Formulator sale price per tablet , $
0.112 microgram
20 mg
0.005 0.032 0.001 0.008
Patient purchase price , $/ tablet Walmart 0.07 1.04 0.11 0.30 Rite-Aid With insurance Rite-Aid Without insurance
0.07 0.2 0.17 0.31
0.7 4.77 0.82 3.97
Current business model
The chemistries , manufacturing methods unit processes and unit operations for APIs are the same as or similar to those for dyes , plastic additives , food , oil , paint , and flavours and fragrances . With these similarities and the equipment available , it was easy to use it to produce APIs and formulate them to a dosage form . 4-7 The only difference between drug molecules and other fine and speciality chemicals is that drugs
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