Discovering Biopharma Technology – A ‘Cutting Edge’ Magazine Interview with Dr. Roberto Castangia

Q: Biopharma Technology provides advanced freeze drying analytical equipment and services. Please share with us your recent milestones achieved and future vision of company? A: Whilst the parent company was formed in 1989, since 1997 the Biopharma Technology division has been providing worldwide support to pharmaceutical, biotechnology and chemical industries offering a wide range of freeze drying solutions for product characterisation, formulation, cycle development, scale-up and production. For over 20 years, our experience has been established with more than 2000 projects developed for APIs, biopharmaceuticals, therapeutic delivery systems, PCR reagents, whole organisms, vaccines and blood components, ensuring success in many industrial processes worldwide. Our customers can now rely on the most advanced technologies that the market can offer in their sample characterisation and process development/optimisation. Q: Please explain in brief about your innovative product lines Lyostat5 & Lyotherm3? A: Biopharma is perhaps the only company worldwide working in the field of freeze-drying that, in addition to research services and training programs, develops unique analytical instruments to advance the science of freeze drying. Recently our product portfolio has integrated the new Freeze Drying Microscope Lyostat 5 with upgraded features. The new generation Electric Impedance Analyser, Lyotherm3, can indeed detect crystal mobility and hidden structural rearrangements thanks to its unmatched sensitivity. Q: Could you please list a few of the specific features that have been improved with Lyostat5 FDM? A: The new Lyostat 5, combines the unique feature of the Pivoting Optics for easy sample loading, to the latest generation camera resolution, user-friendly software, temperature range upgradation, image station with fully compatible with the new DSC module, new Analyser Collar and Tint plate assembly etc. Q: What are the typical services offered using BTL analytical methods for freeze drying? A: We help customers by providing solutions across the entire process development and optimization of their formulations and cycles. When working upstream, we can assist in basic thermal analysis and sample characterisation, finding a suitable formulation for a API or drug products and giving proof of concepts. Stability, shelf life and transportation are among the most common issues in the product commercialization that we are asked to address. We also support customers in scale up and troubleshooting for specific issues. Q: Which are all the different standards and compliance adopted in your latest systems? A: In Biopharma we are conscious about the regulatory restrictions of our customers and we address them with solutions that span across CFR21 compliant software, IQ/OQ validation, and application based tools. In addition, we manage the process development with a systematic approach in full agreement with Quality by Design (QbD) guidelines. With our comprehensive methodology, our customers can rely on detailed and certified documentation that can be presented to regulatory agencies successfully speeding up the entire submission process. Q: What are the upcoming training events that you would recommend for our customers in India? A: Our highly regarded lyophilisation technology training courses are delivered in the UK, Europe and USA and provided as scheduled, 2 or 3-day sessions (Calendar for 2018 Scheduled Courses will be released very soon) In addition to our scheduled course, we do offer fully customised webinars or on-site training courses too. Q: Please share your thoughts on your long term relation with Spinco Biotech? A: The well-established partnership with SPINCO has […] proven to be the successful response to the increasing demand of pharmaceutical services in India. Thanks to Spinco-BTL […] joint efforts and qualified technical expertise; we can deliver premium quality support with unique customer experience at all levels. We are working on strengthening our collaboration even further, aiming to support the Indian customers with a series of seminars and planning for the first Indian training course to be delivered in 2018.

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