Polpharma – major expansion in the API and CDMO space 1st February 2021
By Claudio Salvagnini Head of CDMO API Business Unit- Polpharma
Claudio Salvagnini, Head of Polpharma’s CDMO business, talks to Chemicals Knowledge Hub about the company’s development, its investments, its growth opportunities and its goals for the future.
It is the market leader in Poland and also in Central and Eastern Europe with products ranging from Rx generics to OTC pharmaceuticals, medical devices, supplements and cosmetics, but it also serves the global market with APIs, ie the US, the rest of Europe and Japan. Its products are sold in more than 60 countries, the company having more than 700 products on the market.
Section of R&D facility in Polpharma Starogard Gdanski. Part of a 1000 sq m facility, comprising 10 labs with 30 fume hoods equipped with state-of-the-art instruments to support chemical and analytical development projects.
“Polpharma has gone through huge growth, transforming assets that were originally coming from nationally owned pharmaceuticals provider to the local Polish market to a private company with a large footprint in Eastern Europe and a global client base,” explains Claudio Salvagnini.“The company has now five production sites in Poland, for both API and finish dosage form, we manufacture APIs for both captive and for external partners on a global basis. And, of course, we combine commercial production with our support for the clinical development phase for our customers in the CDMO space,” explains Claudio Salvagnini. “Of course nowadays, to be a major player in the CDMO space, you need to have a large toolbox of chemical capabilities and also combine this with an agile and flexible use of assets and workforce, which is in Polpharma DNA.
“We have seen a movement in terms of types of APIs,” he continues, “they’re getting more and more complex, so that’s why manufacturers such as Polpharma need broad technology capabilities; also in terms of potency of products, as you know an increasing number of products now, especially in the oncology space, are high-potency products, so suitable containment systems and procedures should be in place to assure safe handling of those products. Polpharma has been upgrading commercial facilities to handle products with OEL down to 1ug/m3and is designing a new R&D and small-scale facility to handle products down to 10ng/m3 to also support our clients in the development of these type of products.”
Our strengths are coming from our 80+ years’ experience in developing and manufacturing APIs, colocation in the same site of R&D, pilot and commercial manufacturing for both API and finished dosage form, in depth knowhow on solid state chemistry,particle size distribution control by milling and micronization and a highly trained and committed team across all functions and departments which is permanently focused on quickly responding and even anticipating customer’s needs.
Polpharma produces almost 5.5 billion tablets, ampoules and vials a year through the work of its employees, which currently numbers 4,500staff. The company’s operations are supported by a range of new technologies, and the Polpharma-Microsoft agreement, which has been in force for a year now, providing for the digitalization of industrial processes in the drug production chain, data analytics, and the use of artificial intelligence to create new digital jobs. Organizations such as Polpharma are part of the development of the Polish Digital Valley.
At Polpharma, digitalization extends to the key areas of digital organization, digital operations, ie production, ‘digital product’ and the digital market. The company has one overall goal – to increase its business efficiency, and above all, to facilitate individual employees’ daily tasks.
Production is the most dynamically developing area in terms of technologies. Four key technologies can be identified here: the Industrial Internet of Things (IoT), Cloud Computing, Artificial Intelligence (AI) and Augmented Reality. The latter is used by Polpharma engineers to build a digital machine model, the so-called digital twin, and to hold training sessions for new employees, monitor the condition of devices, or retool production lines.
The use of these technologies in Polpharma’s factories is the result of the work of technicians, engineers and pharmacy experts supported by technology and digital solutions from the Microsoft Azure platform. At Polpharma’s Warsaw plant, for example, employees use IoT solutions and artificial intelligence algorithms to monitor key technological parameters, while Blokchain technology has been used in the digitalization of processes related to the supervision of employee exposure to harmful and mutagenic factors.
Polpharma is the first company in Poland to receive a certificate confirming the compliance of its purchasing system with the ISO 20400 Sustainable Procurement standard. ISO 20400 is the first international standard with the strategic goal of supporting companies in creating and implementing a sustainable purchasing policy.
Polpharma says the award of the certificate is the result of the consistent implementation of its Sustainable Supply Chain strategy and confirms the company as a leader in developing the best market standards in the area of sustainable development in Poland.
Section of the pilot plant in Polpharma Starogard Gdanski. The pilot plant is equipped with 25 reactors ranging from 50 to 650 L, including glass-lined, stainless steel and Hastelloy reactors with different types of stirrers (anchor, propeller, impeller), enabling greaert flexibility in scale-up of chemical processes.
ISO 20400does not contain specific requirements for suppliers and is not a tool for assessing supplier sustainability performance but instead describes how organizations can integrate sustainability into their procurement process. Polpharma decided to include the Sustainable Supply Chain in its corporate social responsibility strategy in 2014 and its activities became the starting point for a new model of cooperation with suppliers, looking at how to raise standards in the supply chain and minimize risks in the field of human rights, work safety and ecology.
The coronavirus pandemic has had little effect on the company’s business so far, although it has impacted the company’s way of working quite dramatically:“To be honest, we haven’t really been impacted in terms of our business but of course our way of working has changed completely since March of this year,” says Salvagnini.
“One thing that could have been of concern was that of delivering product to our clients and customers. Luckily, we didn’t see any disturbance of that because the supply chain we had put in place in the past proved robust enough to assure us of continuity in our current timelines. On the other hand, of course, we have entered a new era since March with a lot more ‘home office’ working and remote connection and communication both internally and also externally with clients, prospects and so on. I have to say that Polpharma was well prepared because some years ago we started a digitalization programme which meant that we entered this situation having a best-in-class platform and solution to ensure, again, this continuity in interaction both internally and externally with our platform for connectivity, for video conferencing, for sharing documentation with clients, and also for bringing clients into the plant by virtual means.
“For instance, quite recently we were successful in doing due diligence with a new client for a newCDMO project because we were able in the short term to allow them to remotely visit our facilities. Normally when you get to do new due diligence and the client doesn’t know you from the past, they want to come and visit the facility and get to know the people, but through the use of digital technology our staff in R&D and production were able to just walk our clients through the facility in a virtual way, giving them the right level of confidence in our equipment, our people and our way of working. So, we were well prepared for this situation and this will probably set the standard for the future too, as we don’t know how long this coronavirus pandemic situation will last and how long it will be before we can regularly travel again or a customer can visit our facilities. Video meetings and virtual tours will start to be a normal way of working.
“Polpharma is already one of the larger player in the API space in Poland and Central & Eastern Europe and we have set the ambition to be in five to ten years’ time one of the main European based API and CDMO company. This will come as a result of our continuous organic growth combined with new investments we have in the pipeline that will keep extending our skillset and technical capabilities and allow us to position Polpharma as preferential partner to our customers all around the globe.” Salvagnini concludes.