The Future of Pharmaceutical Manufacturing – Linear or non-linear thinking?

Recently, I was reading an article in a prominent pharmaceutical trade magazine on the Pharmaceutical Manufacturing Facility of the Future. While, this article made some goods points and it was unclear to me the time horizon that they were forecasting over, this article concerned me that we are using linear thinking instead of non-linear thinking. Linear thinking is the thought process where we believe that today is an improvement over yesterday, and tomorrow will be a slight improvement over today. It’s what engineers are trained to do. Basically, how can we improve X by 10% or 20%. However, non-linear thinking is the process of jumping from idea to idea until a significant  breakthrough is achieve. Non-linear thinking almost always requires looking at a problem from an entirely different perspective. In the words of Astro Teller – Caption of Moonshots for the Google Solve for <X> Project, “A different perspective is much more powerful than just being smarter.” For example, linear thinking might describe a problem as “How can we improve a car such that we get 50 miles per gallon of gasoline?” Non-linear thinking might describe a problem as “How can we get 500 miles out of 1 gallon of gasoline?” or even “Why do we need a car in the first place?” When you think this way, it requires an entirely different approach. It cannot just be an extrapolation of what we are currently doing today.

Using the above example of the pharmaceutical manufacturing facility of the future, linear thinking we might ask, “How can we improve flexibility, quality, potent compound safety, reduce costs, etc?” Non-linear thinking might ask the question, “Do we even need a manufacturing facility in the first place?” As an example, here’s a concept for a printer that produces drugs.

Is this a wild idea? Yes, but that’s the point, and innovation in this direction is already occurring. Novartis Pharmaceuticals has teamed with MIT to develop a continuous manufacturing process, and GSK already has deployed liquid dosing technology. Will there be challenges? Yes. Will there be naysayers? Of course. Will it require regulatory changes? Yep. But, one thing is for certain, don’t underestimate the power of innovation.

For example, when the human genome was first sequenced back in 2001, the cost was about one hundred million dollars, within two years that cost was cut in half, in less than a year it was halved again. Today, by the end of this year, the cost to sequence the human genome is expected to be close to $1,000 – now that’s a non-linear improvement!

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Amphetamine (mixed) Occupational Exposure Limit (OEL)/Acceptable Daily Exposure (ADE)

Affygility Solutions is pleased to present our featured OEL Fastrac monograph for mixedamphetamine OEL and ADE amphetamines. This monograph not only contains the occupational exposure limit (OEL) for amphetamine, but also the acceptable daily exposure (ADE) value. Amphetamine is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) and narcolepsy (1, 2). The mixtures available for weight control combine more than one amphetamine, which may be considered essentially a single-entity drug such as Obetrol® tablets containing 2.5 or 5 mg each of dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine aspartate, and amphetamine sulfate. Click on the following link to order and download the OEL Fastrac monograph for amphetamine with the OEL and ADE.

Occupational Exposure Limits and Acceptable Daily Exposure Values for Pharmaceuticals

OEL Fastrac monographs offer the following benefits:

  • Save time! Unsurpassed digital delivery with instant download.
  • Expert preparation. Industry experts with advance degrees, professional certifications, and decades of experience.
  • Fully documented. 9-11 pages in length, with calculations and cited references.
  • High quality. Proprietary 18-point quality process.
  • Save money. Similar documents cost 8-12 times as much.
  • Stay current. Automatic notification of revisions at no additional costs.

For more information, and to browse our catalog of over 250 OEL/ADE monographs, go to oelfastrac.com.

 

 

 

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Risk Assessments – The Forgotten Art workshop at HPAPI Summit 2013

risk assessment pharmaceuticalsDean M. Calhoun, CIH, President and CEO of Affygility Solutions will present Risk Assessments – The Forgotten Art workshop at the HPAPI Summit 2013 to be held May 28th – 30th, 2013 in Philadelphia, PA.

Risk Assessments – Why You need to Understand the Process

Often, in potent compound safety programs, the process of risk assessments is mistaken for the process of determining the toxicological hazards of an active pharmaceutical ingredient (API) and placement of that API into a specific hazard category. Unfortunately, while understanding the toxicological hazards of an API is very important, it is only one part of the overall risk assessment process. The determination of the hazard category for an API does not  tell you the overall scale of the process, the physical form that it will be handled, the type of systems that it will be handled, and many other factors that may influence the potential for occupational exposure to the API.

Risk Assessment Workshop – What You will Learn

In this highly interactive workshop, the attendees will be expected to leave with knowledge of:

  • The risk assessment process
  • Knowledge of governmental regulations that require risk assessment
  • Different types of risk assessment methodologies such as PHA, HAZOP, What- If, FEMA, AIHA’s qualitative exposure assessment model, and others
  • An understanding why risk assessments as an essential component of a potent compound safety program
  • Currently available tools to assist in the risk assessment process In addition, the attendees of the workshop will have the opportunity to practice the use of these tools on real-life examples.

To register for this workshop and the rest of the HPAPI Summit, go to http://hpapi-summit.com/

In addition, if you’re attending the HPAPI Summit and would like to arrange a meeting with Mr. Calhoun to discuss risk assessments or other elements of a potent compound safety program, please complete the contact us form on the Affygility Solutions website.

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Featured OEL Fastrac Monograph: Fingolimod

Affygility Solutions is pleased to present our featured OEL Fastrac monograph for Fingolimod, Fingolimod is a human therapeutic indicated for the treatment of relapsing forms of multiple sclerosis. To find out more go to the Fingolimod OEL Fastrac page.

Occupational exposure limits and acceptable daily exposure values for pharmaceuticals

OEL Fastrac monographs offer the following benefits:

  • Save time! Unsurpassed delivery with instant download.
  • Expert preparation. Industry experts with advance degrees, professional certifications, and decades of experience.
  • Fully documented. 8-11 pages in length, with calculations and cited references.
  • High quality. Proprietary 18-point quality process.
  • Save money. Similar documents cost 5-12 times as much.
  • Stay current. Automatic notification of revisions.

For more information, and to browse our catalog of over 249 monographs, visit oelfastrac.com today!

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