Author: Nigel J Smart PhD

Biopharma 4.0; Bioprocessing and where is it going?

The biopharmaceutical industry has come a long way in the last 40 years since the cloning of recombinant DNA was achieved and monoclonal antibodies were invented in 1975 by Cesar Milstein at the MRC, Cambridge, UK. The market for drugs and therapies from the biopharmaceutical industry will top over $400 billion very soon and this puts a great strain on companies to manufacture and distribute those products that are so much in demand. One great development that “caught fire” in the last 15 years has been the advent of the single use methodology of manufacturing. This has not only...

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Supplier Client Relationship Issues; Making it work

As we talk and listen to clients and customer prospects about what areas trouble them the most, we are constantly hearing about supplier related issues and how they are associated with performance. Perhaps this should not be such a big surprise as the industry progressively moves towards more and more advanced outsourcing strategies, where internal project management of those resources becomes critical. How that is accomplished by companies can vary significantly depending upon the size of the organization, technology products involved and the proximity of the supplier to the customer. However, there are some basic issues which always are...

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How to Leverage Lean Principles to Improve Quality Compliance

In todays complicated competitive world of Life Science products, production, which now includes; genes, stem cells and other regenerative medicine products, it’s vital that the systems and mechanisms that we employ are able to maintain reliability consistently. This is true of any Life Sciences products such as pharmaceuticals, but for these broader “Medicine” categories which are employing various human tissues, it’s critical that we perhaps build more robust systems for sustainable compliance. The reason for this is because the possibility of failure isn’t just as easy as rejecting a batch of tablets, it’s perhaps losing a limited batch of...

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Why a Lean Laboratory Approach Can Yield Dividends?

In a world of rapidly changing dynamics, any mechanism that can integrate QC laboratory operations with the manufacturing suite to increase efficiency will prove popular with site management. Why is this, what are some of the drivers which might influence decision-makers? Four prime drivers include; the potential for higher throughput, a reduction in cycle time, the opportunity to reduce waste in all its many forms and for the potential to streamline the overall process if it’s properly integrated with production, quality assurance and supply chain. Adding together the impact of these individual reasons produces a very significant benefit which...

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The Importance of Key Performance Indicators

Einstein said it best, science for science sake without good measurement would not lead to progress. With this in mind then, it is vital that we measure our performance whether it be in the laboratory, the manufacturing suite or some other department such as quality assurance. In fact, today, to attain the desired state of what we are calling the “Brilliant Factory State”, it is important to measure the whole enterprise so that we take advantage of and capitalize on the performance of the entire organization. Today in the new global economy this is vital to maintain competitiveness. Processing...

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