“Polpharma has invested over €35 million in a new facility to handle HPAPIs”

#SpeakPharma with Polpharma

2023-09-11

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Over the recent years, the market for contract development and manufacturing organizations (CDMOs) has been growing at a fast clip owing to a plethora of factors such as the rising demand for biologics, new trends towards personalized medicines and the need to bring new treatments to the market more quickly. This week, SpeakPharma interviews Dawid Ignatowicz, Head of Key Account Management, CDMO, Polpharma, to know how the Polish drugmaker is growing its CDMO business and some of the inherent advantages it enjoys in this landscape.

Of late, there has been an increase in demand for drug substance development and cGMP manufacturing services. How is Polpharma gearing up to meet this demand?

In fact, the number of drug developments has increased over the past few years. This coupled with some lack of capacity in some major European CDMO’s, potentiates good opportunities for companies like Polpharma.

Over the last few years, Polpharma has been growing its offer on the CDMO, either by adding new capabilities in research and development and in production or by increasing its manufacturing standards (compliance, EHS, etc.).

Our objective is to support our customers into the different phases of drug development, as such we have adapted our systems to be able to answer their requirements on the different stages – with the ultimate goal of providing a reliable, efficient, and cost-effective service to the customers.

What differentiates Polpharma from other CDMOs?

Our major strengths can be referred as: good project management skills (we have a group of experienced people that help the customers), transparency (since the inception of a project we have developed a clear and transparent way of communicating flow with the customer so that we can have full visibility of their project in our site), an ability to listen to our customers (a rather simple requirement, but that seems difficult to find in the market), good process design (more delivery kilos of a product we want to establish a good efficient and cost-effective process) and flexibility (we understand that development projects could have changes on the timelines and the capability to adapt to those changes is critical).

Besides the above, we have a positive track record of regulatory approvals coupled with experience and expertise in filing to the FDA. We have positive pre-approval inspection audits (PAIs) that reaffirm our robust quality management system. We are known for efficient management of changes and deviations — we are both open and collaborative and work alongside our clients.

Tell us about the range of CDMO projects that Polpharma handles.

Owing to our decades-long experience in drug substance development, regulatory filing, and commercial manufacturing, Polpharma can support customers at various phases — from clinical supplies, through validation and launch, up to regular commercial supplies.

Manufacturing highly potent APIs comes with several challenges, especially with respect to toxicity and exposure. Are you observing more projects with high toxicity?

In order to address the growing demand for the development and manufacture of highly active compounds, we have invested over €35 million in a new facility to handle HPAPIs that will include process and analytical R&D, small-scale cGMP manufacturing suites and quality control (QC) labs. This facility will allow us to handle compounds with an occupational exposure limit (OEL) value down to 10 ng/m3 (or OEB6, i.e. very high contamination).

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Of late, there has been an increase in demand for drug substance development and cGMP manufacturing services. How is Polpharma gearing up to meet this demand?

What differentiates Polpharma from other CDMOs?

Tell us about the range of CDMO projects that Polpharma handles.

Manufacturing highly potent APIs comes with several challenges, especially with respect to toxicity and exposure. Are you observing more projects with high toxicity?