What's happening?

As only the molecular species of the drug at the absorption site can cross the nasal epithelium, sufficient drug solubility is a prerequisite for any absorption.

With the Falsified Medicines Directive (FMD) deadline in February 2019 drawing closer, many CDMOs will be faced with an organisational upheaval in preparation for the new regulation.

Taking a promising drug candidate from the laboratory to first-in-human (FIH) studies is a complex and multi-faceted process.

Innovation in formulation development continues to be driven by the need to improve drug bioavailability.

The contract manufacturing sector is being shaped by many factors, including a focus on innovative therapies and the need to offer even greater value to pharmaceutical companies. CDMOs such as Recipharm are responding by investing in new technologies, adding capacity and building in new markets.

Developments such as the consolidation of the outsourcing space and the upcoming serialisation regulations in Europe are influencing today’s pharmaceutical industry.

The 29th March 2018 marked the one-year countdown to Brexit. While many companies in the pharma industry are campaigning for a ‘soft’ exit from the EU, there is a risk that the complexity and bureaucracy of the regulatory landscape will increase dramatically if a ‘hard’ Brexit is implemented.

Times have changed. The pharmaceutical contract services landscape is more competitive than ever, with CDMOs continuing to develop their service offering and implementing strategies to help them stand out in the marketplace. The quality of manufacturing is no longer the sole decision-making factor.

In early drug development, the toxicology, bioavailability, pharmacokinetics (PK) and pharmacology of a compound need to be analysed using a liquid formulation. Often solubility becomes a challenge, meaning excipients are needed to optimise the solubility.

The US Food and Drug Administration (FDA) released the Standardisation of Data and Documentation Practices for Product Tracing guidance last week, which extends the standards outlined in the Drug Supply Chain Security Act (DSCSA).