IPI Speaks with Hendrik Kneusels, CEO of Laetus Observing the Means to a Secured Supply Chain

Laetus was founded in 1974, and is the pioneer of pharmaceutical packaging security. It all started with the barcode identification system ARGUS, which over the years became the industry standard for packaging material identification. Based on that sound know-how, Laetus developed further solutions to increase security for patients. In the 90s, we developed the first camera system in the market for blister inspection. It was followed by highly sophisticated vision systems to increase and ensure the quality and effectiveness of the products for our customers.

Authentication; A Sensible Investment

When counterfeiting is reported globally, pharmaceutical products receive most of the attention because peoplefearpoisoning,contamination, and medicines that don’t cure. Yet the pharmaceutical market spends less on authentication technologies as a percentage of sales than the luxury market. Why? Part of this is due to the unique way prescription drugs are distributed in the largest global market, the US, where the patient seldom sees original packaging.

Pharmaceutical Piracy Colour-Coded Security and Traceability

The problem of counterfeit medicines was first addressed at the international level at a World Health Organization (WHO) conference in 1985. Things have come a long way from there, and much has been undertaken to combat the growing threat of fake medication. Yet, while governments and organisations are discussing the implementation of a uniform definition into their respective legislations, and guidance is being published for mass serialisation of prescription medicines, the counterfeiting ‘business’ is shifting to new markets.

Conversion Processes Now Key to Assuring Compliance in Pharmaceutical Packaging

Pharmaceutical packaging manufacturers increasingly agree to ‘zero fault’ supply agreements from brand owners in order to win contracts. To meet the requirements of these agreements, manufacturers have to make their quality assurance procedures more robust than ever before – a costly and time-consuming business. However, help is on hand from an unlikely source.

Innovative Glatt Fluid bed Pelletising Technologies

In multi-particulate systems the dosage of the drug substance is – in contrast to classic single-unit dosage forms like tablets – divided on a plurality of sub-units, consisting of thousands of spherical pellet particles with a diameter of typically 100 – 2000 ?m. Although their manufacture and design is more complex in comparison to classic single-unit dosage forms, multi-particulate dosage forms offer a magnitude of different interesting options and advantages to accomplish unique product characteristics and in particular specific drug release patterns.

LyoSeal®: Compliance, Quality and Production Tool

Our injectable medicines are most often available in a glass vial closed by a rubber stopper and a crimp seal, an arrangement more than a century old. Is it true to say that the pharmaceutical industry has lacked innovative power during that time? On the contrary, this simple packaging format has led to numerous progresses in the past decades. However, recent studies, new regulations and emerging products suggest that there is still a significant potential for improvement in fill and finish operations.

CMO PAT Implementation: Time for Strategic Decisions

Process analytical technology (PAT) is a vital step towards a future where continuous manufacturing and real- time product release can become real in the pharmaceutical sector. After a slow start, PAT is high on the agenda for Big Pharma. But it is not so common among contract manufacturers (CMOs). What is holding them back and what are the issues they need to consider?

the diabetes pandemic: Responding to FDA Guidance on Cardiovascular Risk in Type 2 Diabetes Treatment

Diabetes is increasing at a disturbing rate both in the US and Europe, and in China. In America approximately 4000 people are diagnosed with type 2 diabetes each day. In recognition of this alarming growth and the ongoing research and development of both preventive and palliative diabetes treatment, in December, 2008 the FDA released guidance on new anti-diabetic drugs.

A ‘Mix and Measure’ Multiplexed assay to assess oxygen consumption and Microbial Metabolism

MitoXpress® is a water-soluble oxygen- sensitive phosphorescent probe that facilitates microtitre-plate based analysis of microbial oxygen consumption. The ‘mix and measure’ procedure allows rapid and specific detection of microbial oxygen consumption providing a simple yet sensitive means of assessing the impact of a given manipulation on cellular function.