2019 round-up and looking forward to 2020

To ardent watchers of this blog - you know who you are - apologies for the pause in postings.  A lot has been happening since August 2019 as we follow our mission to accelerate process development and positively impact the development of every potential medicine.

We'll be posting more regularly in 2020, with lots of news and new capabilities in the pipeline.  In the meantime, here's a catch-up on some items from the latter part of 2019 and a picture that summarizes a few of them:

A few Scale-up Systems and Scale-up Suite highlights from the end of 2019; more details below.

• We presented our sponsored AIChE award for Outstanding Contribution to QbD for Drug Substance to the 2019 winner, Zoltan Nagy of Purdue University, at the Annual Meeting in Orlando [pic - top right]
• We nominated John Peterson of GSK for the corresponding Pfizer-sponsored Drug Product award, for his excellent work on statistics of design space, and he won.  Was great to catch up with John at the awards session [pic - top left]
• Andrew Bird presented statistically rigorous calculations of design space for three common unit operations; and ways to dramatically accelerate the calculations [pic - top centre]; watch for the details in a 2020 webinar
• A growing band of Dynochem and Reaction Lab users are keeping warm this winter in our 'beanie' hats, helping the environment with our keep-cups and looking forward to summer in our poloshirts [pic - bottom centre]
• And we've updated our certification programs to a fully automated on-line system with randomized questions.  Visit the Resources site and search for 'certified' to find out more and take the test.

Congratulations to Dr Jake Albrecht of BMS: Winner of AIChE QbD for Drug Substance Award, 2017

At AIChE Annual Meetings, Monday night is Awards night for the Pharma community, represented by PD2M.  This year in Minneapolis the award for Excellence in QbD for Drug Substance process development and scale-up went to Dr Jake Albrecht of Bristol-Myers Squibb.  Congratulations, Jake!

Winners are selected using a blinded judging panel selected by the Awards Chair, currently Bob Yule of GSK.  Awards criteria are:

• Requires contributions to the state of the art in the public domain (e.g. presentations, articles, publications, best practices)
• Winner may be in Industry, Academia, Regulatory or other relevant working environment
• Winner may be from any nation, working at any location
• There are no age or experience limits
• Preference is given to work that features chemical engineering

Jake was nominated by colleagues for:

• his innovative application of modeling methodologies and statistics to enable quality by design process development
• including one of the most downloaded papers in Computers and Chemical Engineering (2012-2013), “Estimating reaction model parameter uncertainty with Markov Chain Monte Carlo”
• his leadership and exemplary efforts to promote increasing adoption of modeling and statistical approaches by scientists within BMS and without
• his leadership in AIChE/PD2M through presentations, chairing meeting sessions, leading annual meeting programming and serving on the PD2M Steering Team

Scale-up Systems was delighted to be involved at the AIChE Annual Meeting this year in our continued sponsorship of this prize.  Some photos and video from the night made it onto our facebook page and more should appear soon on the PD2M website.

Jake is also a DynoChem power user and delivered a guest webinar in 2013 on connecting DynoChem to other programs, such as MatLab.

Congratulations to Dr Marty Johnson of Lilly

Congratulations to Dr Marty Johnson of Lilly, Indianapolis on being this year's winner of AIChE's prize for Outstanding Contribution to Quality by Design for Drug Substance process development and manufacturing.

Marty's nomination was based on a very strong record of innovation and publication related to continuous manufacturing (CM) of active pharmaceutical ingredients and their intermediates, including:

• being a driving force behind the pharmaceutical industry’s adoption of continuous processing
• advocating how continuous processing can transform the quality, safety and cost profile of the pharmaceutical manufacturing sector
• design of equipment platforms that are scalable and able to handle a range of process chemistries and conditions, and
• more than 25 external publications including innovative ways to run chemistry, equipment characterization, reactor development, process modelling.

Scale-up Systems was delighted to be involved at the AIChE Annual Meeting this year in our continued sponsorship of this prize.  Marty stopped off in San Francisco en route to Asia to collect his award.  Photographs of the awards session will be available here soon. 

Interested in knowing more about CM?  Attend the CM2017 Workshop in Ireland in February 2017.

AIChE 2015; QbD, Awards, Reception; honoured to be made a Fellow

Readers of this blog (and members of the DynoChem community in general) will be aware that the AIChE Annual Meeting is an excellent place to learn about the current practicalities of implementing QbD.

The 2015 Annual meeting took place in Salt Lake City earlier this month and three of our team attended, Peter, Marion and myself (Joe).  We attended the pharma sessions mostly, plus a few process development, green chemistry and mixing sessions.  We were delighted to see so many customers presenting their DynoChem work and you can download a list of papers that referenced DynoChem here (Microsoft OneDrive) or here (Dropbox).  We also presented on some lab reactor characterisation work carried out with Pfizer and this will be presented as a DynoChem webinar in 2016 and the slides will be made available in DynoChem Resources.

We participated in the QbD Awards presentation, where the drug substance prize sponsored by our company (Scale-up Systems) went to Dr Dan Hallow of J&J (formerly BMS).

And we held a reception/party for our customers, which we run every few years, featuring news and previews of forthcoming tools and the DynoChem Jeopardy game, in which the categories this year were Chemistry, Chemical Engineering, Ireland and DynoChem.  A team assembled from Hovione (Portugal), Dow (Freeport, TX) and Eastman (Kingsport, TN) won the prize.  For more pictures, see our Facebook page.

Winners of DynoChem Jeopardy at AIChE 2015

Finally, I had the honour this year of being made a Fellow of AIChE, a distinction that I will wear with pride and also leverage to spread the word about the power of excellent chemical engineering in today's world.

Here's what customers say when we support them on their projects

Here are a few quotations from customers during recent support cases.

• "Great! Thank you soooooooooooooo much for all your help"

• "I am finding your software and documentation very useful."

• "We are convinced of the added value this software tool can bring in our process development and scale-up work"

• "Fabulous ... thanks for your help ..."

• "This is definitely what I needed to answer some processing questions.  Thanks."

• "I have always found the support from Scale-up Systems to be rapid and attentive.  Keep up the good work!"

• "... thanks for your support. We are extremely grateful to you."

• "Thank you for helping ... with this model.  It has been a great asset for the project as it cut down the amount of time we could have spent trialling the equipment by giving us a ‘sweet spot’ of operating conditions that would yield the desired concentrations."  

• "That is brilliant - thank you so much for spending the time to find this very random error! I really appreciate it. The support we get from the DynoChem team is fantastic."

• "That’s the most complete answer I have ever gotten from any support team, thanks!"

If you're starting or working on a project with DynoChem, contact us anytime at support@scale-up.com and you'll soon be saying things like this.

And a big thanks from our team to all of the customers who provided the feedback above.

At least 14 industry talks to feature DynoChem applications at AIChE 2014 Annual Meeting: get the list here

We are looking forward to seeing so many of our global customers at the AIChE Annual Meeting in Atlanta next week.

Let us know if you would like to meet up.

You can now download a list of highlights and talks that feature DynoChem at AIChE 2014 from OneDrive here: http://1drv.ms/1wTJ9js.



In our own talk on solubility, we'll be showing (very quickly!) some new features that make automated screening and plotting of solvent mixtures a snap.

Are you certifiable? Take the test to become a Certified DynoChem User

DynoChem skills are a great asset to have in a pharmaceutical company.  They can make your job more interesting and satisfying while making you more effective and faster in completing projects.  They allow you to help others in your team to get the same benefits.  They're also great for your career progression and future employment prospects.

Now you can demonstrate these skills to all by becoming a Certified DynoChem User, on successful completion of a Certification Test.

We've anticipated a few of your questions and provided the answers below:

Q: What exactly do I have to do?
A: Take a 90-minute certification test using DynoChem at your own desk.

Q: How do I get the test questions?
A: Send an email to our support and training team with 'Certification' as the subject line.

Q: What do I get in return?
A: Several things:

• You can describe yourself as a Certified DynoChem User.  
• You receive an official signed and stamped certificate to this effect (hardcopy and PDF).  
• You can hang it on your office wall, use it  in your resume, list it in your LinkedIn profile, etc.

Q: Sounds great.  Let the games begin.
A: Steady on.  Email us now to get your copy of the test.

AIChE QbD Awards 2013: Nominations close on 14 June

There is just one week left in which to make further nominations for the AIChE QbD Awards this year.  

Awards Chair Bob Yule of GSK has been promoting the nomination process and more nominations are welcome.  Apart from the Drug Substance and Drug Product awards, the Integrated award goes to someone who is speaking at AIChE 2013.  So if you get time, please take one last look at the abstracts and see if any speaker merits a nomination for this award.

Please also spread the word via your own networks.  More info at http://www.aiche.org/community/divisions-forums/pd2m.

Winners of 2012 AIChE Awards for QbD

Congratulations to John Lepore and Christine Moore, winners of two of the 2012 AIChE Awards for Outstanding Contribution to QbD.

More details here: http://www.pharmaqbd.com/winners-of-2012-aiche-awards-for-qbd/

Nominations for AIChE QbD Awards: 2012 (Pittsburgh) now open at http://bit.ly/QbDNominate

Nominations for the AIChE QbD Awards, to be presented at the 2012 Annual Meeting in Pittsburgh, are now open to all at  http://bit.ly/QbDNominate.

There are three awards:
- Excellence in QbD for Drug Substance, sponsored by DynoChem
- Excellence in QbD for Drug Product, sponsored by Pfizer
- Excellence In Integrated QbD Practice, sponsored by Merck.

Please submit nominations by 11 May 2012. All nominations will be considered by the awards committees.

For information about previous winners, see articles on PharmaQbD.com:
http://www.pharmaqbd.com/aiche_qbd_awards_2011/
http://www.pharmaqbd.com/aiche_awards_seibert_garcia-munoz/

Photographs from AIChE: Integrated QbD Practice and QbD Awards session

On our facebook page we have shared a sample of photographs from the Merck-sponsored session on Integrated QbD Practice at last month's AIChE Annual Meeting. Photos by Greg Helgeson with thanks to AIChE. 

The pictures below show Dr Jose Tabora of BMS receiving the award for Outstanding Contribution to QbD for Drug Substance, sponsored by Scale-up Systems (DynoChem).