18 Pharmaceutical Technology
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BioPharm International
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Bio/Pharma Outsourcing Innovation February 2025 PharmTech.com
SUSTAINABILIT
Y
"Waste generation is another challenge we face in
our industry, because we are constantly generating
a lot of byproducts, which can be hazardous in na-
ture, so careful management and disposal of these
waste materials is very important. Solvent use tends
to be a big challenge, because solvents leave a huge
footprint on the environment, and finding greener
a lternatives or rec ycling solvents can be a major
challenge for us," says Davuluri. "We would like to
reuse solvents, but then, on the f lip side, when you
reuse solvents too much, there is a risk of genotoxic
impurities forming in the product, and that can cre-
ate other challenges as well."
Rega rd i ng i n h a l at ion produc t s, Bu r n s poi nt s
to the complication of removing one par t of a for-
mation and replacing it with another one, because
of the chemical and physical differences bet ween
ingredients within a formulation. "We effectively
have to develop produc t s r ig ht f rom scratch. I n
terms of feasibi lit y work [and] t he stabi lit y work
t hat's required in order to deliver t he same phar-
maceutical performance that is required for the pa-
tient when they're taking the therapy, it needs to be
identical. The before and af ter picture needs to be
identical," says Burns. "Because meter dose inhal-
ers are complex combination products, taking new
propellants, which effectively have been used in car
air conditioning units and ref rigerants for years
and years and years, we're now repurposing these
propellants. Obviously, it's medical grade, because
it's ingested into the body, as opposed to the crude
propellant, but we have to make sure that what the
patient sees is identical in terms of pharmaceutical
performance, but there's no detrimental effect on
ef f icac y and safet y, so we have to go through the
clinical trials again."
A better future
Pharmaceutical regulators and industry stakehold-
ers have taken steps to safeguard the environment
for future generations, as well helping to generate
social and economic value through sustainable ap-
proaches (4). The contract organizations that work
with sponsor companies can be a crucial partner for
ensuring success in these endeavors.
References
1. IQVIA. Environmental Sustainability in Pharma.
IQVIA .com. 2021.
2. EcoVadis. Pharmaceutical. https://ecovadis.com/
initiatives/pharma/ (accessed Jan. 29, 2025)
3. ABPI. Sustainability in the Pharmaceutical Indus-
try. Apbi.org.uk (accessed Jan. 29, 2025).
4. EMA. Environmental Policy. Ema.europa.eu. May
15, 2024. (accessed Jan. 29, 2025).Q
Expert Insights on Sustainability
Visit PharmTech.com to watch the following videos
on sustainability in pharma:
Sustainability in Inhalation and Small-Molecule Drugs
Andy Burns, vice president, MDI Business Development
at Kindeva, discusses how sustainability requirements
are impacting contract development and manufactur-
ing organizations, specifically for the development and
manufacture of inhalation drugs.
Watch Now!
Sustainability in Pharmaceutical Outsourcing
Saharsh Davuluri, Vice-Chairman and Managing Director,
Neuland Laboratories, talks about how the push to sus-
tainability is impacting contract manufacturers.
Watch Now!
Sustainability in Pharmaceutical Manufacturing
Charles Ruban, president and CEO, Verdot, speaks
about the focus of moving to sustainability practices in
pharmaceutical manufacturing.
Watch Now!
Creating a Sustainable Approach
Roger Viney from ICE Pharma highlights the importance
of sustainability for the bio/pharma industry and some im-
portant future considerations for companies.
Watch Now!
