Application note: Process Analytical Technology employed in the Freeze Drying Process to determine the End of Primary drying and Cycle Optimisation
June 14, 2024Application note: Process Analytical Technology employed in the Freeze Drying Process to determine the End of Primary drying and Cycle Optimisation
June 14, 2024
Biopharma Group’s Director of R&D is globally recognised as a lyophilisation expert. Kevin has been in the field since 1993 and joined Biopharma Group in 2000. He’s been involved numerous academic research projects and, together with his team, has worked on over 4,000 projects for customers worldwide.
Kevin received his PhD for investigations into the freeze-drying of pharmaceutical formulations and drug/vaccine delivery systems. Prior to joining the team, Kevin worked at Pfizer Central Research and as a Research Fellow in vaccine development at Aston University.
Dr. Ward is an editor and a contributing author of articles and texts on freeze drying, most recent being the Springer book “Lyophilization of Pharmaceuticals and Biologicals”. He is also in demand as a frequent lecturer to many of the leading regulatory agencies and prominent pharma companies. In his spare time, Kevin is part of a small acapella group, who sing at weddings and charity events, who recently performed a concert for Ukraine and raised more than £3000 for medical supplies.
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Now based in California, David is Head of Technical Services at Biopharma Group, having rejoined the group in 2013 as a Senior Scientist following experience as a coordinator in the NHS and various analytical laboratories. David was promoted to the senior management team in 2016, having built up significant experience in the freeze-drying industry, providing analytical research, consultancy, and product and process development for customers worldwide. Since then, David has helped expand Biopharma Group’s technical portfolio, leading the growth of the R&D laboratories and assisting the move into diagnostic and GMP pharma production.
David particularly enjoyed his leading role in Biopharma Group’s covid production campaign which saw ‘all hands to the deck’ and a large expansion in staff as we developed and manufactured up to 100,000 covid tests per day throughout the pandemic.
In 2024, David will pivot slightly away from the operational side of the business and take up a more commercial role. This will involve assistance to the Heads of Sales for the various business areas in finding new opportunities for growth.
Outside of work, David enjoys spending time with his family, and 3 children.
Edmond is the Research & Development Manager at Biopharma. With over a decade of experience in the pharmaceutical industry spanning roles as a Pharmacist, Principal Scientist, and now an R&D manager. Edmond joined the team in 2014 after a PhD from Aston University in Birmingham, UK. His PhD focused on optimising the bulk freeze-drying process and the implications of powder rheology using methods including the novel use of Micro X-ray tomography. He also holds an MSc in Pharmaceutical Science with Management Studies (Distinction) from Kingston University in London. Edmond brings a unique perspective to drug development, leading a team of talented scientists and brings a wealth of expertise in stabilising parenteral, biologics, small molecules and in vitro diagnostics using rigorous research and development. Edmond’s expertise in lyophilisation has proven invaluable to numerous small to large biotech and pharmaceutical companies over the years through consultancy. Beyond the lab coat and boardroom, Edmond has a passion for football and enjoys crafting delectable dishes in the kitchen.
Chelsea has 10 years’ experience working in laboratories across both industry and academia settings. She joined Biopharma in 2016 as a Research Assistant in the R&D laboratory and progressed to Senior Scientist, working on thermal analysis characterisation and developing freeze-drying cycles. In 2020 the company expanded its production services for medical devices and Chelsea moved into this department to manage its operations as Production Manager. She has successfully transferred multiple projects into manufacturing developments and helped customers to streamline processes. Alongside this, she is a quality management representative and supports the company with holding its ISO 9001 and ISO 13485 accreditations.
One of Chelsea’s most memorable projects was freeze-drying goldfish for an art exhibition piece.
Pranav has almost 10 years of scientific experience in the pharmaceutical industry, and hands-on technical experience. A pharmacist by training, his academic achievements include a Ph.D. in Liposomal Drug delivery from Aston University, an M.Sc. (with Distinction) in Pharmaceutical Sciences from the University of Greenwich and a bachelor’s degree in pharmacy. Prior to joining Biopharma Group, Pranav worked at multi-national pharmaceutical companies, including Aesica Pharmaceuticals Ltd., LM Manufacturing Ltd., Cipla Ltd, Serum Institute Pvt. Ltd. as a Formulation and Early Product Development Scientist, and Pfizer as a part of industrial collaboration.
He joined Biopharma Group over 5 years ago as a Senior Scientist. In 2023, he earned a promotion, seamlessly transitioning into the position of Principal Scientist. He brings considerable expertise and a versatile skill set to the forefront of dosage form development, tech transfer, scale-up, and validation activities. In his current role at Biopharma, he has emerged as a specialist in lyophilisation, providing valuable consultancy support to meet the diverse needs of existing and new clients. Throughout his professional journey, he has acquired in-depth expertise in Pre-formulation studies, Process design and Quality-by-design (QbD) concepts. He is recognised for his adept interpersonal skills, effective leadership, and ability to foster inclusive and supportive work environments. Beyond his professional pursuits, he indulges in his passions for travel, culinary exploration, and dancing during his leisure time.
Bhaskar joined Biopharma Group in 2021 as a Senior Scientist after a PhD from De Montfort University in Leicester, UK. Working with Professor Geoff Smith, his PhD was centred on the single vial monitoring of the freeze drying process using through vial impedance spectroscopy (TVIS). At Biopharma Process Systems in Winchester, Bhaskar is managing several highly collaborative projects for clients in the pharma and diagnostics sectors involving product and process assessments, formulation development, lyophilization cycle development, post process analyses, packaging and consultancy for new and existing products.
Bhaskar holds a BSc (Hons) in Pharmaceutical and Cosmetic Science with a sandwich industrial placement within product development of Zydis® ODT at Catalent in Swindon, UK. He also holds a master’s by Research (MRes) from University College London, where his research involved exploring the paediatric application of hot melt extrusion and cyclodextrins for reformulating a poorly soluble active ingredient.
Bhaskar has been playing the ‘Tabla’, an Indian percussionist instrument since childhood and loves to jam! He is also a Cricket enthusiast and dreams to play in the World Cup after retiring!
Andrew is the Chairman of the PE487 Group which is the ultimate owner of the divisions that make up Biopharma Group. Andrew led the purchase of the original freeze dryers division (Biopharma Process Systems) in 2009 when he, and three private shareholders bought the company and started the process of development that has taken Biopharma Group to where it is now.
Andrew is not a scientist but has applied his experience in a variety of businesses to protein stabilisation and its associated processes, and products. Andrew also chairs an automotive component group and is a director and trustee of a scientific prize fund.
Outside of his business interests Andrew has a small farm where he runs a flock of sheep.
With over twenty years of experience spanning biopharma, biotech, and food industries, Roberto leads as Group Sales Director the commercial side of PE487, overseeing the diverse group of companies that fall under the Biopharma Group umbrella to provide innovative solutions for the life sciences and healthcare sectors. Holding a PhD in Chemical Biology, he bridges his scientific background with business experience to develop and execute global strategies, services, and development of new products.
Outside his business interests, Roberto does coaching, sports and enjoys his love for the sea travelling back to Sardinia.
A degree in Electronic Engineering and a commercial MSc led to 20 years as MD of several large organisations, much of it in supplying the food, pharma, and cleanroom sectors with equipment and services. For the last 7 years, Andrew has been as Group Operations Director at Biopharma Group with responsibility for service, R&D, laboratory and GMP operations, as well as the operations of our other acquisitions.
Andrew is a great believer in “get it right first time”. At Biopharma Group, we have the ability to make decisions and act quickly to get things done, do it once and do it right.
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Niloofar, aka Niloo, joined Biopharma Group as a Research Scientist in 2020, becoming Senior Scientist in 2024. She has a wealth of expertise in molecular biology techniques and lyophilization as well as extensive experience in managing diverse projects, formulating products, and equipment validation. Niloo’s educational background includes a MSc in Genomic Medicine and a BSc in Molecular and Cellular Biology (Genetics).
The core of her role is developing understanding of client's requirements ahead of project commencement, creating strategies, and executing projects aimed at meeting those needs. It involves sharing our expertise with the customer in areas such as formulation development, freeze-drying cycle development, process improvement and stability assessments. This allows us to help our clients complete their product development efficiently to a high standard, while ensuring they are delivered on time and within budget.
Outside of work, Niloo enjoys skiing and surfing.
Mervyn holds a BSc (hons) Biochemistry Degree from the University of Portsmouth. After graduating in July 2009, Mervyn joined Biopharma in December 2009, where he worked for six years to 2015. During this time, Mervyn gained significant experience of product analysis and freeze-drying cycle development/optimisation. Following this, Mervyn joined the Bio Products Laboratory (BPL), where he worked within a production setting, gaining considerable experience of the operations of production freeze-dryers and the management of GMP cleanroom environments. During his time at BPL, Mervyn also attained a master’s degree in Biopharmaceuticals from King’s College London, having conducted a research project within the R&D department at BPL which focused on the impact of viricidal heat treatment processes on Factor VIII/ vWF concentrates.
Mervyn returned to Biopharma Group as a Senior Scientist in February 2021 and has since worked on approximately 55+ customer projects involving a range of activities, including characterisation of both pre-lyophilised and lyophilised products, formulation development, freeze-drying cycle development and optimisation, process auditing and consultancy on all stages of the freeze-drying development and scale-up process. Additionally, Mervyn is a contributor to the freeze-drying courses provided by Biopharma, during which he delivers lectures and provides hands-on training with the freeze-drying equipment and analytical instruments associated with product characterisation.
Mervyn lives by the seaside with his wife, three young children and three small dogs. Together they love doing lots of seaside related activities, including walks along the beach, kayaking and paddleboarding.
Please use our handy ROI calculator to demonstrate how investment in R&D on your products such as cycle audits, formulation development, cycle development, analysis, etc., can potentially save money at each batch run due to improved quality and efficiency. Simply add your values & use the slide rules for each segment to see your potential results*.
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Sam started at Biopharma Group after graduating from Reading University with a degree in Biological Sciences, focusing on molecular biology and biochemistry. Following this, Sam completed an additional research project in the cardiovascular laboratory at Reading, examining protein expression/inhibition in murine red blood cells.
Sam started at Biopharma in 2020 as a Research Assistant in the R&D department and progressed to Research Scientist in 2022 where his main responsibilities include project management, customer communication, freeze-drying formulation and cycle recipe development and performing pre/post lyo analysis. Since joining Biopharma, Sam has worked on a wide range of pharmaceutical and diagnostic projects, including drug product and drug substance, collagen scaffold and lipid nanoparticle development, as well as IVD assay design and development, including the design of IVDR-compliant assays in Lyobead format ranging from drug detection sprays to PCR mastermixes.
Sam loves to travel and enjoys the opportunity to visit customer sites to perform training courses and consultancy in person.
