All articles by Ky Nikitha
Generation excipients
There are a number of different parenteral-grade excipients used in biopharmaceutical formulations. Deciding between them can be challenging, particularly in light of today’s stringent regulatory requirements. Abi Millar speaks to Rajsekhar Paul, fellow at Novartis, focusing on late-phase pharmaceutical development in biologics, about moving beyond pharmacopeia to next-generation parenteral excipients.
The circle of life
Manufacturing a cell or gene therapy is difficult and costly. Unlike other types of drugs, these living cells demand a sophisticated and circular process that is individuated for each patient. Minh Hong, head of commercial development for cell therapies at Lonza, speaks to Louise Thomas about optimal strategies when manufacturing these drugs, including how to choose the right technology.
The smart money
Smart packaging offers huge value to the whole of the supply chain. There are a number of recent innovations that can help optimise monitoring. Louise Thomas speaks to Ruud van der Geer, associate director supply chain management EMEA, MSD, about the opportunities and future directions within the field.
Risk versus reward
For parenteral drug products, there is a need to further investigate the materials that will be in contact with the drug product during manufacturing, storage, final packaging or the delivery of the drug to the patient. Jim Banks speaks to Carsten Worsøe, principal scientist at Novo Nordisk, about what is needed to better mitigate risk and optimise documentation for extractables and leachables.
Connect the dots
AI is set to play an increasingly important role in the pharmaceutical industry, providing life science companies with faster, more efficient ways of uncovering drugs, sourcing data and responding to regulatory challenges. Will Moffitt speaks to Joerg Stueben, senior expert of global regulatory operations at Boehringer Ingelheim, about the implications of the technology.
A helping hand
Since 1997, pharma has been looking at additive manufacturing (3D printing), trying to understand what role it will play. Its value is clear, but to pinpoint where it should be used best still remains a challenge. Andrew Tunnicliffe speaks with Professor Clive Roberts, head of the School of Pharmacy at the University of Nottingham, and explores the possibilities.
The first move
There is increasing talk of ‘patient-centricity’ within the industry. Incorporating this concept into drug delivery can be challenging but provides huge opportunity to improve adherence. Louise Thomas speaks to John Burke, senior consultant at Team, about the best practices when implementing this approach.
Ride the wave
The ability to share data throughout the entire supply chain is essential to optimise logistical services for pharmaceutical products. To achieve this goal, the implementation of digital technologies plays a key role. Emma Green speaks to Niels Hackius, research associate at the Hamburg University of Technology, about the range of tools available, particularly the value of blockchain.
On closer inspection
While there is widespread knowledge of the growth of the illicit drugs trade, pharmaceutical experts say serialisation compliance is only part of the solution. Patrick Kingsland speaks to Guido Holzem, senior intelligence manager global GxP & eCompliance QA at Grünenthal; Pasi Kemppainen, a management adviser at Santen Pharmaceutical; and Géraldine Lissalde-Bonnet, director of public policy at GS1, about how best to protect pharmaceutical companies and patients.
Learn to adapt
Machine learning provides the ability to gain real-time insights and predictive information from trials. This technology can be leveraged to prevent study risks, ensure timely clinical trial supply and better manage resources. Yuri Martina, vice-president of clinical operations at Grünenthal, speaks to Emma Green about how to implement this technology to maximise these benefits.