All articles by shirleyaccini
shirleyaccini
Excipients: pharma’s silent partners
Keith Horspool, vice-president of pharmaceutical development at Boehringer-Ingelheim, discusses the propagation of excipients, the industry’s unsung heroes.
Special drug delivery
As pharmaceuticals become more complex, developing efficient delivery methods is vital to ensure therapeutic efficacy. Sudip Das of Butler University explores a selection of the latest formulations and medical devices with Jack Wittels, and calls for greater collaboration between pharma companies and device manufacturers to face the delivery challenges of tomorrow.
Pharma cold chain: a calculated risk
The combination of the rapid globalisation of the pharmaceuticals market and growing demand for complex, fragile and temperature-sensitive biologics is making the transportation of healthcare products an increasingly complicated challenge for pharmaceutical companies, Chioma Mensah-Bonsu, UCB Pharma, tells Nic Paton.
Behind the healthy cover of supply chain security
Between 2006 and 2009, 7.5 million fake drugs were seized at EU borders, prompting Big Pharma to step up efforts to unmask pharmaceutical fraudsters. Nic Paton investigates with David Colombo of Eli Lilly & Co, and Francois-Xavier Lery, Council of Europe’s EDQM.
Boxing clever with pharmaceutical packaging
Pharmaceutical packaging plays a pivotal role in improving compliance, reducing counterfeiting and creating brand equity. However, with budgets remaining tight, any new solutions must be balanced against their impact on the drug development pipeline. Guido Schmitz, Bayer HealthCare, tells Abi Millar how the drive to reduce costs is compromising creativity in the field.
eCDT’s benefit performance
As the preferred format for regulatory submissions to the FDA, the eCTD offers strategic advantages to sponsor organisations. In this white paper, Greg Onyszchuk of Cardinal Health Specialty Solutions explains how outsourcing can achieve the benefits of eCTD while also lowering cost, effort and risk.
Birth of cyber-collaboration
Mollie Shields-Uehling, president and CEO of SAFE-BioPharma Association, explains how the industry’s interests in collaboration and cloud computing entered into consciousness at just about the same time, creating cyber-collaboration.
Outsourcing manufacturing: change is the only constant
Outsourcing manufacturing is popular among pharmaceutical companies but recent changes to GMP guidelines across Europe have important implications for contract manufacturing organisations and their customers. One significant change is that drug companies will be responsible for ensuring their partners are compliant and must share the technical know-how to allow this to happen. Kim Steffensen of Novo Nordisk explains all to Nic Paton.
Digital leap into the pharmaceutical production line
Paul Ludorf of Rottapharm looks at how the use of software systems by the first generation of digital natives has been the key to creating a culture of continuous improvement on the shop floor.
Emerging markets come in from the cold
The cold chain faces many challenges – temperature integrity, data monitoring, storage and regulation among them – and where infrastructure is less established, these become harder to overcome. Allergan’s Henryk Junker talks to Jim Banks about managing the process in emerging markets.