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Hyper Innovations in Pharma 2015

Reporter : Gérard Henri Loiseau, ESQ

 

Bio Pharma 2015: Soaring to New Heights

Pharmaceutical Manufacturing, Steven E. Kuehn, Nov 10 2015

 

Growth Statistics

Bio Pharma is an “evolving accelerating science” (John J. Castellani, PhRMA).

R&D spending which was

$2 billion in 1980 is estimated

$51,6 billion in 2013,

it represents 1 in every 5 dollars spent on domestic R&D in the US.

90% is spent on Clinical Trials,

6199 Clinical Trials in 2013.

>$2.6 billion is the cost estimated to develop and bring a new drug on the market

In 2014 FDA approved 44 drugs, so a good year both for NCEs and NBEs, Forbes Magazine, Bernard Munos

 

Hyper Innovation

According to Mr. Munos the main players are

  • Novartis
  • J&J
  • GSK
  • AstraZeneca

Deloitte’s report “Advanced Biopharmaceutical Manufacturing: An Evolution, Underway” identifies several targets:

  • Continuous manufacturing
  • New process analytical tools
  • Single-use systems
  • Alternative downstream processing technique

Amgen vice president Jim Thomas points out:

  • A more competitive business environment
  • A more challenging reimbursement environment
  • A more conservative regulatory environment

There is a necessity for the highest quality manufacturing environments.

“Design the molecule. Design the Process. Design the plant,” is his credo, which generates its “transforming Biotechnology Manufacturing” initiative

  • Trends in analytical tools will support operational excellence
  • Bio therapeutics manufacturing will be centered on cell-based systems
  • A greater productivity within a smaller footprint will be allowed
  • Flexibility is the goal thanks to standardized processes across all stages

These are the keys to operational excellence.

 

Process Analytical Technology (PAT)

FDA’s perspective is that ”quality cannot be tested into products; it should be built-in or should be by design”

Deloitte estimates that PAT can promote fewer recalls and less scrap inventory.

 

Towards a continuous future?

A recognized potential for small molecule drugs, and some companies have developed this continuous technology.

Deloitte’s study says that FDA views continuous manufacturing as consistent with the FDA’s quality by design efforts.

How to define a batch in case of product recall is a true challenge, which means that new measurements methods are needed.

Continuous manufacturing opposed to efficient, well-planned and engineered facilities, which is the vision developed by Amgen and others innovative players.

SOURCE

http://www.pharmamanufacturing.com/articles/2015/bio-pharma-2015/

 

 

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