Category — Drug Delivery

We strongly support diabetes research on this site so wanted to share this: (BBC)

Tighter control of blood sugar levels in people with diabetes may cut their risk of heart problems, a study says.

From the Cambridge Study (30000 patients) just published in the British Lancet the following is observed:

Lead researcher Dr Kausik Ray said: “Previous studies have been inconclusive, leaving diabetics and their doctors unsure as to whether maintaining lower blood sugar levels actually benefited the patients.

“Although additional research needs to be conducted, our findings provide insight into the importance of improving glucose levels. However, this has to be done through lifestyle changes as well as medication.”

Results were fewer heart attacks and 15% less cardi-vascular desease.

ICH Q10: final guidance for implementing an effective quality management system for the pharmaceutical industry.

The FDA has just issued its final guidance on ICH Q10.

This internationally harmonized guidance is intended to assist all pharmaceutical manufacturers by describing a model for an effective quality management system called pharmaceutical quality system. Based on International Organization for Standardization (ISO) quality concepts, it includes applicable good manufacturing practice (GMP) regulations, and complements ICH “Q8 Pharmaceutical Development” and ICH “Q9 Quality Risk Management.”

Interestingly, this model can be implemented throughout the different stages of a product lifecycle and strengthen the link between pharmaceutical development, manufacturing and commercial activities.

It reinforces the need for Leadership which is essential to establish and maintain a company-wide commitment to quality and for the performance of the pharmaceutical quality system to achieve product realization, to establish and maintain a state of control and to facilitate continual improvement.

FDA also insists that companies use knowledge and quality risk management and apply this guidance to their outsourced activities and the purchase of raw materials while conducting assessments of suppliers and service providers before entering into an agreement.

This conference, supported by industry opinion leaders and exhibitors will take place in Paris January 21, 22, 2009.

The event provides a unique opportunity to not only update on state of the art scientific developments but also to do business with like minded people in the drug packaging and drug delivery business.

The location is LA GRANDE HALLE DE LA VILLETTE – HALL Charlie Parker.

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Bruno Cocheteux is a Managing Partner at Sibaya LifeScience!

A team lead by Kimberly Hamad-Schifferli, assistant professor of biological and mechanical engineering at MIT has discovered a method to use gold particles and infrared to release multiple drugs in a systematic and controlled manner.

This is of particular importance when treating diseases like cancer and AIDS which require multi drug and coordinated dosage cocktails.

The new technique takes advantage of the fact that when gold nano particles are exposed to infrared light, they melt and release drug payloads attached to their surfaces.

Nanoparticles of different shapes respond to different infrared wavelengths, so “just by controlling the infrared wavelength, we can choose the release time” for each drug, said Andy Wijaya, graduate student in chemical engineering and lead author of the paper.

More information from MIT is available here with an interesting diagram here.

Following on from their entry into the home healthcare business through their acquisition of Respironics, Philips has now acquired Medel, a leading aerosol therapy business based in Italy. As a bonus they also get an established manufacturing base in Guangdong, China.

According to CEO Don Spence:

Philips Home Healthcare Solutions CEO Don Spence, who in November 2008 succeeded former chief executive John Miclot, said: “When Philips acquired Respironics, the company also had a leading respiratory drug delivery business. Building upon that strength and fulfilling on our ambition to expand our high-growth compressor nebulizer systems franchise, we decided to acquire the aerosol therapy business of Medel which allows us to better serve the needs of our customers and their patients who suffer from asthma, chronic obstructive pulmonary disease (COPD), cystic fibrosis and other respiratory disorders.”

This is another smart move by Philips exanding it’s position in the higher value end of the homecare business as well as the drug delivery side homecare.

The question is what next in homecare? Diabetic therapies (also fits drug delivery), dialysis… or perhaps the most obvious, wound care. We could suggest several great candidates.

We have blogged quite a lot about the homecare respiratory business (including) about Respironics in the past. you may find this background interesting.

News Release

There is no doubt that the economic recession which has now touched all parts of the world is taking it’s toll on most industries.

One of the most resilient however is the healthcare industry. Sibaya LifeScience! recently interviewed several companies supplying services to “big pharma” in the form of contract manufacturing – especially drug delivery – at ICSE, P-Mec, Cphi – Frankfurt, Germany. While this was not a scientific study, anecdotally we were told that it was business as usual, in fact for some, business was clearly on the increase as manufacturing was being outsourced to contract manufacturers.

Not the case though for small and medium sized biotech companies according to this report in the IHT which lists companies in the Biotech hub in Massachusetts struggling for cash and laying off employees. Biotech companies need cash to fund research while waiting for their revenues to hopefully arrive one day, but in the US biotech companies have only been able to raise about half of what they did in the prior year.Technorati Tags: biotech, contract manufacturing

The United States FDA has just issued a new

Guidance for Industry: Process Validation: General Principles and Practices

This is an important new proposed guideline document and the FDA is inviting comments within 60 days of it being published in the register.

Our initial observations at Sibaya LifeScience! are:

Aligning process validation activities with the product lifecycle concept and with existing FDA guidance, this guidance now includes biological products and active pharmaceutical ingredients.

It also specifically provides recommendations with the Risk-Based Approach for technological advances in pharmaceutical manufacturing.

It clearly defines process validation ‘as the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products’

From our perspective one of the most interesting guidance points is the consideration of having an integrated team composed of a variety of specialties to cover process knowledge, facility design and equipment selection among others.

The full text is available from the FDA or it is available as a PDF file from their site.

We would be interested in your views which you can add below by clicking on the comments link.

Bruno Cocheteux is a Managing Partner at Sibaya LifeScience!