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Feature


ADOPTING PLANT-BASED PLASTICS TO CREATE SINGLE-USE SYSTEMS




THE BIOPHARMACEUTICAL INDUSTRY IS ADOPTING PLANT-BASED, SINGLE-USE PLASTIC
SYSTEMS TO REDUCE ITS ENVIRONMENTAL IMPACT AND MEET INDUSTRY STANDARDS FOR
SAFETY AND COMPLIANCE.

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By
 * Alivia Kaylor, MSc, Senior Editor

Published: 18 Nov 2024

In an industry traditionally reliant on petroleum-based plastics for single-use
systems, a shift is underway as companies embrace plant-based, biodegradable
alternatives that align with stringent safety standards and environmental goals.
With growing pressure on the healthcare and biopharmaceutical industries to
reduce their environmental impact, innovative solutions are emerging to tackle
one of the biggest sustainability challenges -- minimizing plastic waste without
compromising on quality or compliance. As a result, forward-thinking
organizations are transforming their manufacturing processes, proving that
eco-friendly practices and regulatory rigor can go hand in hand.



Green Elephant Biotech GmbH, a sustainable bioprocessing and labware solutions
company, is stepping up to address these issues. Led by Joel Eichmann,
co-founder and managing director, the company has introduced a range of
eco-friendly products, notably their CellScrew system, which offers a
sustainable alternative to traditional plastic-based cultivation equipment.


SUSTAINABILITY CHALLENGES IN SINGLE-USE SYSTEMS

Single-use systems -- though necessary for sterility -- are a major contributor
to plastic waste. These systems are often composed of petroleum-based plastics,
such as polystyrene, which are difficult to recycle and frequently end up in
incinerators, releasing significant carbon emissions.

Eichmann highlighted this industry-wide problem: "The life sciences industry
faces significant sustainability challenges with single-use systems, primarily
due to strict regulations that prioritize single-use products for safety and
sterility. These products are often made from polystyrene and other
petroleum-based plastics, which contribute to environmental issues starting with
their raw material origins."

Green Elephant has embraced a plant-based alternative called polylactic acid
(PLA).

"These challenges are being addressed by developing products from renewable,
plant-based sources," Eichmann said. "Polylactic acid, a biopolymer derived from
plant starch, meets regulatory requirements and is biocompatible. Choosing PLA
reduces reliance on crude oil and significantly lowers carbon emissions, even in
end-of-life scenarios that require incineration."

PLA, a thermoplastic polyester, is derived from any fermentable sugar and is
generally produced from renewable, organic sources. Corn is the preferred raw
material for PLA production because of its low cost and widespread availability,
though sugarcane, tapioca root, cassava, wheat and sugar beet pulp are also
viable alternatives. Notably, PLA's degradation products are nontoxic to humans
and the environment. PLA also requires 25%-55% less energy to produce than
traditional petroleum-based polymers.

With FDA approval for direct contact with biological fluids, PLA presents a
promising alternative that meets industry safety standards while lowering
traditional single-use plastics' environmental impact.


REDUCING CARBON FOOTPRINT WITH THE CELLSCREW SYSTEM

Green Elephant's flagship product, the CellScrew system, has proven to be a
game-changer in terms of reducing carbon emissions. According to Eichmann, "The
CellScrew system achieves a substantial reduction in carbon footprint -- up to
90% -- compared to traditional cell cultivation systems, depending on the
specific system being replaced."

This reduction is achieved through two primary mechanisms: the use of PLA and
the company's efficient design.

The CellScrew system is manufactured using additive manufacturing, which reduces
material waste. Its design also allows for a material-to-surface ratio that is
ten times more efficient than competing products, which drastically reduces the
amount of plastic required per experiment.

"One CellScrew 6K provides the same surface area as 34 T-175 flasks, 12 roller
bottles, or one multilayer stack," Eichmann noted. "This compact design,
comparable in dimensions to a standard 850 cm² roller bottle, significantly
reduces the volume of plastic needed per experiment, thereby lowering the
overall carbon emissions associated with plastic usage."


THE ADVANTAGES OF PLA OVER MASS-BALANCE CERTIFIED MATERIALS

The choice of PLA over other "sustainable" materials is intentional. Eichmann
explained the benefits of PLA, especially in contrast to materials certified via
mass balance methods.

"PLA has a strong record in medical technology applications, providing a
reliable, safe material already proven for use in pharmaceutical environments,"
Eichmann said. "Medical-grade PLA is readily available, supporting stringent
regulatory requirements. Moreover, Green Elephant's PLA-based products are fully
traceable, which is critical for compliance in the pharmaceutical sector."

Eichmann contrasted PLA with materials certified by mass balance, a process that
can sometimes be misleading regarding a product's renewable content.

"An additional advantage of PLA over other bio-based materials lies in its true
biobased composition, which differentiates it from materials certified through
'mass balance' methods," Eichmann said. "In mass balance systems, only a
percentage of the raw materials are derived from renewable sources, with the
rest typically from fossil fuels. However, because of the allocation process, a
final product can be marketed as 'sustainable' even when it contains limited
biobased content."

This transparency in material composition is essential for any company's
commitment to true sustainability. Using 100% biobased PLA ensures that products
are genuinely sustainable, providing clients with a high level of confidence in
environmental claims.


OVERCOMING INDUSTRY BARRIERS

Implementing sustainable solutions in the pharmaceutical industry presents
significant challenges, especially considering that it emits 55% more greenhouse
gases than the automotive sector. By last fall, 53% of biopharma companies had
pledged to the United Nations' Race to Zero initiative, aiming to cut emissions
by half by 2030, an increase from 25% the previous year. However, only 4% of
companies are actually on track to meet this target.

Additionally, nearly 100 pharmaceutical companies currently have an average low
carbon transition rating of 2.8 degrees Celsius -- far from the UN goal of
limiting warming to 1.5 C by 2030. In addition, the average management score for
these companies is 42 out of 100, highlighting a need for stronger efforts.

According to Eichmann, "Promoting sustainable products and practices isn't the
primary challenge; the real difficulty lies in implementing these solutions."
Due to its cautious nature, the pharmaceutical industry is often slow to adopt
new approaches, and recent market volatility has caused some companies to
deprioritize sustainability goals.

Green Elephant is addressing these obstacles by engaging closely with industry
stakeholders to showcase their sustainable solutions' regulatory compliance and
long-term environmental benefits.

"Green Elephant actively engages with stakeholders, emphasizing the value,
practicality and compliance of our solutions, which offer sustainable benefits
in a challenging industry environment," Eichmann added.


EMPOWERING SCALE-UP WITH THE CELLSCREW MINI

To support smaller companies in the scale-up phase, a compact version of the
CellScrew, known as the CellScrew mini, was developed with a surface area of 850
cm². This system provides an affordable solution for early-stage testing,
allowing organizations to assess the advantages of the CellScrew system before
committing to larger-scale implementation.

"The CellScrew mini is our entry-level system, developed in response to customer
demand for a compact cultivation option that allows for early-stage testing and
evaluation of the system's potential," Eichmann said. "This system is
particularly beneficial for companies in the scale-up phase."

By offering an accessible, lower-cost option, this approach enables smaller
companies to explore sustainable practices and scale up their operations without
a significant initial investment.


ADVANCING SUSTAINABLE BIOPROCESSING

Eichmann revealed plans to create an automated version of the CellScrew designed
to streamline cell therapy manufacturing by minimizing manual handling, thereby
reducing labor demands and conserving valuable resources. This innovation aims
to increase operational efficiency while supporting sustainability goals within
the industry.

"An automated version of the CellScrew is in development to significantly reduce
the manual handling time required in cell therapy manufacturing and other
labor-intensive processes," Eichmann detailed. "This automated, closed system
will enable processes to be conducted in lower-grade clean rooms, helping
clients save substantial energy and resources, which further enhances the
sustainability of their operations."

With innovative solutions like plant-based cell cultivation systems and a
commitment to genuine biobased materials, this approach offers scalable,
eco-friendly options that adhere to the life sciences industry's rigorous safety
and regulatory standards. Through a focus on collaboration, transparency and
ongoing advancement, these efforts are helping to improve sustainability in the
healthcare sector.

Alivia Kaylor is a scientist and the senior site editor of Pharma Life Sciences.



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