What's happening?

Serialisation represents a huge challenge for the industry. From the costly and complex implementation process, to the enormous task of data management, many within the pharmaceutical industry have found serialisation to be a daunting prospect.

Mark Quick,executive vice president of corporate development at Recipharm, joins a panel of industry experts in this roundtable with European Pharmaceutical Manufacturer to talk about the biggest trends of 2017 and the future of the industry.

Poor solubility can be a real issue during drug development, as it can lead to low bioavailability, which causes suboptimal drug delivery, and often risks the drug being withdrawn from development.

Serialisation has been widely talked about across the industry for some time. Despite this, many companies have failed to prioritise developing a solution meaning ensuring compliance come the various market deadlines is becoming increasingly difficult. 

Getting a drug from formulation development to first in human (FIH) trials can be a complex process that costs pharmaceutical companies huge amounts of time and money, and if a drug fails, it can be catastrophic for the businesses involved.

Inhalation drug products have a multitude of benefits when delivering treatment to the lungs, including a faster onset because of direct delivery to the area requiring therapeutic treatment and reduced occurrence of adverse effects.

Staffan Widengren, Director of Corporate Projects at Recipharm recently took part in a Manufacturing Chemist roundtable to discuss the challenge of new serialisation regulations put in place to protect against counterfeit medicines.

This month Erik Haeffler, Vice President of Manufacturing Services at Recipharm took to the Medicine Maker alongside other serialisation experts to discuss whether the industry is ready for the upcoming regulatory deadlines and to dispel the misconception that serialisation is simply ‘adding a label to the box.’

The approach involved testing the interactions of 30 different excipients with six commercially available drugs, with a diverse range of properties.

Dr Amjad Alhalaweh, a formulation scientist at Recipharm, takes to Pharmaceutical Manufacturing 

Erik Haeffler, Vice President of Manufacturing Services and Head of CSR at Recipharm, discusses the DSCSA enforcement delay with Contract Pharma and outlines what companies should be doing now to ensure they are ready ahead of the deadline next year.