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

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

    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).  

    Impressions: 2400

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    #SpeakPharma With Polpharma
    11 Sep 2023
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    “Polpharma has the best equipment and team to deliver impurity-free products”

    “Polpharma has the best equipment and team to deliver impurity-free products”

    N-nitrosamine impurities have been in the news for some years now. SpeakPharma interviewed Karina Boszko, Head of API Regulatory Affairs and Customer Technical Support Department at Polpharma, a leading API and FDF manufacturer, to understand this challenge. She gave us a lowdown on nitrosamine impurities, steps undertaken by regulators and Polpharma, and what other API manufacturers need to do in order to eliminate them from their drugs. Excerpts: What are nitrosamines and how do they affect human health? In July 2018, the pharmaceutical industry was taken by surprise when nitrosamine impurities were detected in human medicines, leading to recalls of several batches of high blood pressure and heart failure med valsartan. Investigations by health authorities and drug companies revealed that nitrosamines are generated during the synthesis of active pharmaceutical ingredients (APIs). Different products containing different APIs, including metformin and rifampicin, were found to contain low levels of nitrosamine impurities. Nitrosamines, or N-nitrosamines, refer to any molecule containing the nitroso functional group. They are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines. They are a cause of concern because they are probable human carcinogens, and long-term exposure to high levels may increase the risk of cancer. Over 300 known nitrosamines, many highly potent mutagenic carcinogens, are known to us today. What steps have regulators taken to check nitrosamine impurities in pharmaceutical products? On September 26, 2019, the European Medicines Agency’s Human Medicines Committee (CHMP) requested all Marketing Authorization Holders (MAHs) to review their medicines containing chemically synthesized APIs for the possible presence of nitrosamines. The EMA recommended a three-step process. In the first step, MAHs were supposed to perform a risk evaluation of APIs and finished products by March 31, 2021. If a risk is identified, MAHs have to perform confirmatory tests. Finally, if tests confirm the presence of nitrosamines, MAHs are supposed to inform competent authorities immediately and implement risk-mitigating measures. They should also submit any changes in the manufacturing process or product specifications by October 1, 2023. The US Food and Drug Administration (FDA) also came up with similar recommendations. Both these agencies have partnered with various other regulators to develop rapid solutions to ensure the safety and quality of drugs. The EMA and FDA have updated their recommendations a few times regarding the potential list of nitrosamines, the sources of nitrosamines and their limits. Why are nitrosamine impurities being reported so much now? The scientific community has been aware of the presence of nitrosamine impurities for years. Today, we have better equipment and better testing methods to detect impurities. At present, we use the gas chromatography–mass spectrometry (GC-MS) or gas chromatography-tandem mass spectrometry (GC-MS/MS) methods due to their high selectivity and low detection levels. At Polpharma, we use GC-MS/MS chromatographs with Headspace auto-samplers and UPLC-MS/MS (Ultra-high performance liquid chromatography-MS/MS) chromatographs to detect impurities as low as 0.001 ppm. What are the potential sources of nitrosamine impurities? There are many ways and conditions that lead to the formation of nitrosamines. The most common is the use of nitrosating agents in the presence of secondary or tertiary amines within the same or different steps of the manufacturing process. The use of contaminated raw materials and intermediates supplied by vendors containing residual nitrosamines or nitrosating agents is another potential source. Additionally, the use of contaminated recovered or recycled materials or certain packaging materials may lead to the formation of these impurities. There is also the fear of cross-contamination due to different processes being run successively on the same manufacturing line. Another source is the degradation processes of raw materials, intermediates and active substances. The lack of optimization of the manufacturing process for APIs can also lead to the formation of nitrosamines. How is Polpharma addressing this risk? Polpharma has already implemented the steps recommended by the EMA and FDA. Over the years, we have updated our risk assessments and developed additional analytical methods. Now, we can confidently say our knowledge of nitrosamines in APIs is huge. The APIs produced by Polpharma are thoroughly analyzed for nitrosamines. If necessary, we test our products with highly sensitive analytical methods developed and validated in-house. In one case, we implemented changes in the manufacturing process in accordance with EMA’s recommendations to minimize the risk of nitrosamines. We have a dedicated team comprising our best technologists, analysts, regulatory affairs experts and process engineers that analyzes our substances for the potential risk of nitrosamines. We also have top-class analytical equipment to develop very sensitive methods for testing our APIs. What challenges await API manufacturers in terms of nitrosamine impurities? API manufacturers should be aware that potable water used in API manufacturing may contain low nitrite levels and nitrosamines. Currently, not only smaller nitrosamines but also nitroso-APIs are an increasing problem for manufacturers, as there is a wide range of potential routes of nitroso-formation. Various APIs and impurities are susceptible to nitrosation, during the later stages of the API synthesis process or during subsequent storage. Several recent drug recalls have been conducted due to contamination with such API-derived complex nitrosamines, also known as nitrosamine drug substance related impurities (NDSRIs), such as nitroso-varenicline, nitroso-propranolol, nitroso-orphenadrine and nitroso-quinapril. At Polpharma, our current focus is on reassessing the risk to determine the possibility of the formation of NDSRIs based on theoretical assessment and confirmatory studies using analytical methods. Can you elaborate on Polpharma’s risk assessment process? At Polpharma, we do our risk assessment for APIs in such a way that we do not rely only on our knowledge of the APIs. We cooperate with our colleagues who are experts in the field of FDF (finished dosage form) formulation, thanks to the fact that we are a company which produces both APIs and FDFs. Moreover, we also cooperate with our customers. We also take precautionary measures to mitigate the risk of the presence of nitrosamines during the manufacture and storage of all medicinal products containing chemically synthesized APIs. I believe that only through full cooperation, information exchange between drug manufacturers and MAHs can the quality and safety of the drugs be guaranteed. Do you see N-nitrosamine impurities getting completely eliminated from drug products in the future? Nitrosamines impurities can be eliminated through good manufacturing practices (GMPs), good/safe chemistry, modification of the synthetic route, elimination of sources of nitrosamine formation and a holistic understanding of the entire manufacturing process. Some available literature reports show that commonly used antioxidants such as ascorbic acid (vitamin C) or alpha-tocopherol (vitamin E) inhibit the formation of nitrosamines in vivo, based on data from human gastric fluid in vitro studies. A second possible approach suggests that nitrosamines are typically formed under acidic conditions. In the future, it will definitely be possible to reduce and even eliminate N-nitrosamine impurities by using our knowledge and advance technologies. What has the industry done to alleviate the concerns of patients? With each news headline about nitrosamine impurities in drugs, people’s trust in drug safety wanes a bit more. Patients complain that there is a lack of clear information from regulators or healthcare professionals regarding the affected medicines. To address this issue, the industry has come together to implement the best practices in communication. Science is constantly evolving. The industry should adopt new knowledge and technology on an ongoing basis to help improve the lives of patients. Our priority should be to provide them with top quality and safe medicines.  

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    #SpeakPharma With Polpharma
    20 Feb 2023
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    “Polpharma API’s ability to control particle size distribution resolves multiple formulation challenges for our clients”

    “Polpharma API’s ability to control particle size distribution resolves multiple formulation challenges for our clients”

    This week, SpeakPharma interviews three experts from Poland’s leading pharmaceutical company, Polpharma. Dorota Pogoda, Manager of the Solid State Chemistry Group, Robert Rynkiewicz, a process engineering expert, and Małgorzata Kujawa, representative of the API analysis team educate us on why particle size is important for the pharmaceutical industry and why it’s a key aspect in the development of APIs. The trio also tells us how Polpharma is managing the process, and the technologies it is using to reach the desired particle size distribution. Excerpts: Tell us why particle size is important to the drug industry D. Pogoda: In the pharmaceutical industry, particle size has become one of the key aspects in the development of active pharmaceutical ingredients (APIs) and quality control of solid oral dosage forms. The physicochemical and biopharmaceutical properties of biologically active substance can be highly affected by the crystal size and its distribution (CSD), also known as particle size distribution (PSD). It is estimated that almost 80 percent of new promising molecules that have biological activity are rejected during the research and development phase due to their low water solubility, which in turn is strongly related to the bioavailability and release of the drug. Therefore, the API solubility parameters, especially ingredients belonging to class II and IV of the Biopharmaceutical Classification System, can be improved by increasing the crystal surface – i.e. by reducing the crystal size. The particle size significantly affects powder flowability, bulk density, hygroscopicity (the tendency of a solid substance to absorb moisture from the surrounding atmosphere), compatibility, porosity, and blend uniformity. These parameters influence every stage of tablet manufacturing, thereby impacting the effectiveness and shelf life of the drug. How do drug manufacturers get the required particle size?  D. Pogoda: The preferred method to achieve the desired particle size is crystallization. However, effective particle size control requires the use of real-time monitoring using analytical aids like focused beam reflectance measurement (FBRM), as well as in-situ attenuated total reflection Fourier transform infrared spectroscopy (ATR FT-IR). FBRM provides a real time measurement of the dimension and number of crystals in the process, while ATR FT-IR enables monitoring of the crystallization process. These technologies are very useful in crystallization process monitoring and controls the PSD of the material. Another method is the mechanical size reduction of solids, which is frequently used to achieve API particle size control. The crystal size reduction can be performed with enough energy to break individual crystals or agglomerates during the formulation process. The mechanical reduction of crystal size leads to crystal surface damage. This can cause the formation of an amorphous phase, polymorphic transformation as well as variations in the crystal size while the material is in storage. How does Polpharma manage the process? R. Rynkiewicz: Polpharma API has several years of experience in delivering APIs with the right particle size distribution through different methods such as crystallization, milling/micronization, vibration sieving or other technologies. We choose the method depending on the need. We have a variety of equipment and a highly specialized team with many years of practice. This allows us to offer APIs with the desired size of particles, in line with our customers’ expectations. Development and optimization of the required PSD begins in the R&D department. It is led by experts from our Solid States Chemistry team, which also supports the entire product lifecycle. To explore the crystallization process on a larger laboratory scale, we use reactors with precise control of temperature gradients and stirring speeds. In addition, we support the crystallization process with an FBRM probe to control the shape and size of particles. The Solid State Chemistry team is involved in developing, scaling-up and implementing the crystallization process. The team also solves any issues that appear during production and works closely with experts from the Process Engineering Team. Crystallization is one of the main ways of getting the desired PSD. Various types of agitators (such as anchor, propeller and impeller) with adjustable stirring speed and numerous crystallization lines with advanced automated systems help us achieve the desired PSD directly from crystallization. Based on the recommendations of our R&D team, appropriate process parameters are applied during routine manufacturing. Desired PSD can be achieved by changing the key process parameters, such as the type of agitator, stirring speed, concentration, cooling rate, usage of seeds with appropriate PSD, etc. Is Polpharma using any other technology for the process? R. Rynkiewicz: Yes. Instead of getting the desired PSD directly from crystallization, we are using other technologies such as micronization, milling and vibration sieving. The choice of technology depends on the need. For the most complicated cases, the statistical methods of design of experiments (DoE) are applied, according to the Quality by Design (QbD) approach. There are many useful designs used for defining the optimum process, such as Central Composite Design (CCD), Box-Behnken Design (BBD) or Factorial Designs (FD). Such an approach guarantees the robustness of the process and the ability to get the desired PSD “for the first time” and every time thereafter.  Polpharma API’s ability to control particle size distribution resolves multiple formulation challenges for our clients. Does Polpharma API have in-house micronization capabilities? R. Rynkiewicz: Yes. Micronization is a commonly used method for PSD. It allows reduction of the API particle to a micrometer size. This technique helps process heat-sensitive products, because the temperature remains relatively constant throughout the process. Polpharma API has two jet-mill micronizers, one in its manufacturing plant and one in the pilot plant. All of them work in full cGMP environment. PSD during micronization occurs without the intervention of any mechanical components. How useful are the milling and vibration sieving techniques? M. Kujawa: At Polpharma API, we are using both these techniques for powder processing operations. Milling is mainly applied to achieve slight reduction in particle size. For this purpose, different types of mills are available with Polpharma, such as pin mills and classifier mills. We apply vibration sieves when a specific fraction with narrow PSD is required. Polpharma API has two vibration sieves working in full CGMP environment. Another challenge is making the right choice of method that allows proper PSD analysis and solves problems associated with crystal/particle morphology. At Polpharma we develop, validate and transfer PSD methods to clients as well as support them in providing solutions in case of any difficulties. You can reach Polpharma at marketingapi@polpharma.com 

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    #SpeakPharma With Polpharma
    09 Sep 2020
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