Five minutes at CPhI worldwide with …
ChemistryToday/PharmaHorizon: What kind of biologicals do you offer?
Federico Pollano: Our CDMO targets all types of biologicals: monoclonal antibodies, custom antibodies and proteins, developed on a fee per service basis. We also offer fill & finish services; meaning that we offer both drug substances and drug products.
CT/PH: Including cell lines?
FP: Yes, recently we started to offer cell line development. This takes place in our daughter company Bioceros, in Utrecht (Netherlands), founded in 2013. They now focus on high-yield cell lines, to meet the expectation of customers not only for biosimilars but also for innovative products. Manufacturing costs are highly related, in biotechnology, with process yield, and this is one of the reasons yield is an important parameter we strive to optimize. We have our own Specific Productivity Optimizing Technology (SPOT) to improve yields – up to more than 6 g/L. We got freedom to operate with proprietary cell lines, so that potential customers are free to operate as well.
CT/PH: What targets are more requested by the market?
FP: We see a high need for flexible, modular solutions due to personalized medicine. Customers demand products needed in smaller quantities but highly targeted. Consequently, to have very fast change overtimes, we work with disposable bioreactors. Now we are working with two 2000-liters disposables for cell cultures but we will arrive to twelve 2000-liters disposable productions in our brand new facility that will be operative in 2019.
CT/PH: And what about microbial fermentation?
FP: We are currently investing into bacterial production plants in Gdansk, already GMP-inspected, and that microbial side will be ready in mid-2018. We are looking for partners to offer our services in bacteria. We will have also fill & finish capabilities there, with a flexible line processing up to 5 million vials or syringes in Gdansk. And in our Duchnice near Warsaw facility we will have a capacity of 30 million of syringes or vials, including lyophilization. We see a huge demand for lyophilized products in biotechnology, already in development but especially in the final product.
CT/PH: How integrated is your CDMO offer?
FP: We promote ourselves as a one-stop shop. Sounds a bit old-fashioned, but it is becoming more and more important again. One-stop shop for us means that we offer all steps of development for a biopharmaceutical, means you can start from the cell line, go through the process development, and from there you can go to upscaling. Our modular approach of 2000-liter disposables makes it easy to scale up. We have an integrated approach from the early beginning – during development in our facilities in Gdansk or Utrecht we already think and set up as in the final scale up step.
CT/PH: What technologies do you use to optimize processes?
FP: We are using AMBR systems, an high-throughput approach that we use to develop and process in parallel to optimize media or other conditions. It is extremely important to be sure that what takes place in small scale is then robust to scale up.
CT/PH: You have operations in Russia. How is it working there?
FP: We have very positive experiences with our footprint in Russia and Kazakhstan. Of course we see more and more discussion around local production becoming more and more a precondition, not only to get the product registered but also from reimbursement point of view. Our target markets are EU, US, Japan. We work in line with all regulations and we are in very good relationship on other markets as well, including local regions such as Middle East and North Africa where you have to fulfil local requirements. This means you need to create value on site, more and more, being a reliable partner as we are for local regulators.
CT/PH: Speaking of regulations, is the new US administration going to change anything?
FP: Whatever will happen, the key success factor is to be in close contact with the regulatory authorities. Since the beginning we started a dialogue, with a scientifically driven, open approach. This makes a difference. You need to keep and involve the regulatory people in what you are doing, how you are doing it and what is the scientific rationale. Our team has 20-25 years of expertise in the regulatory sector in both EU and US, and this type of close collaboration is key.
CT/PH: Overall, how is Polpharma Biologics
FP: This year is closing very well for Polpharma Biologics. We have reached our growth goals and we are going through GMP inspections. Our developments are on track, our setup in Gdansk is on track as well, our large scale facility in Duchnice is a reality.