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Innovations in pharmaceutical flexible manufacturing?

Welcome Posted on Thu, January 21, 2016 20:33:07

Many pharmaceutical facilities are facing a new need for flexibility. Unlike the old “blockbuster plants” the pharmaceutical facilities of the future are no longer dedicated but multiproduct and they must be agile and flexible. Several of the newest pharmaceutical breakthrough products are quite small products from a volume perspective but they manufacture quite expensive products.

The number of new drugs approvals has been increasing the last few years with a record high 2015 and since many of the new products are for quite small markets, the demands for flexibility is high. Many pharma companies have increased their use of contract manufacturers in order to achieve the needed flexibility. By definition the CMOs generally have good multiproduct capabilities but they also face the future need of more flexibility and agility to meet their customers’ market demands.

But there is a lack of highly flexible pharma manufacturing equipment. Most of the traditional solutions are not quick to change and clean between products because there has been more focus on operational efficiency than on changeover efficiency. Like in the automotive industry 25 years ago.

You may remember that cars used to be made in dedicated facilities many years but today car plants are highly flexible with lots of robots and modular design models to enable agile and cost-effective manufacturing.

We do not use robots in the pharma industry. With few exceptions in packaging plants or in distribution warehouses. The is a need for a new pharma manufacturing paradigm that is flexible. Companies needs innovative suppliers and also some eye opening reference projects that set new standards.

The regulators such as FDA have expressed the vision of an agile, flexible and effective pharmaceutical manufacturing sector. It is up to the plant managers, engineering companies and equipment suppliers to make that vision possible…

1-January 2016

Welcome Posted on Tue, December 29, 2015 20:42:42

New blog – new pharmatrend perspectives

This is a beginning of a new blog that captures the focused area of pharmaceutical manufacturing, technology and compliance.

Why a new blog when the world is crowded with blogs? Because there is a need for independent views on what the trends are. You make take many decisions in your daily work life without having time to look across the dots that makes a line. The pharmaceutical industry has been undergoing significant changes over the last decade but we are only beginning.

My blog is dedicated to what comes. Not based on speculations but on what we know. Based on facts. As I have done in numerous keynote presentations over the last years, I connect the dots to show where the challenges will be.

Just one example: Agility. If there is one thing that the pharmaceutical industry has not yet been good at, it is agility. Why? Because the GMP’s told us not to be. For decades the pharmaceutical industry has been conservative, risk-adverse and very slow to adapt changes. But there is a new pharma reality that only few companies have understood. Despite the fact that the head of US FDA’s CDER (Center of Drug Evaluation and Research), dr. Janet Woodcock has been expressing a vision for the pharmaceutical industry for more than 10 years now, very few companies are taking it serious.

The vision of dr. Janet Woodcock is expressed as: “A maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high quality drugs without extensive regulatory oversight.”

The question for us in our companies is: how do we make it a reality? Because the fact is that the vision was not intended to be a dream. It was – and it is – intended to become a reality