xCellarate Technology Consulting Inc.

And so it officially begins, for regulatory recognition of the AI revolution in our industry... I can't think of anything in recent memory in our industry that has as far reaching implications and impact, for better or worse, as AI... What do you think?!

For all the challenges and uncertainty we face in the world today, we wish prosperity and success to all of our partners, friends and network in 2025! #gmp #biomanufacturing #compliance

Hey everyone, the annual break from work this year for me is family vacationing in France! As part of this I fulfilled a bucket-list dream of mine this week to ride and summit Mt Ventoux in Provence! Anyone that follows the Tour de France knows of its legend as a fabled and epic climb. I’m so happy to claim that I made it to the top! It was an incredible experience and culmination of training and background preparation over the past months. The seeds of the dream were planted more than 20 years ago when I watched an unsullied Lance Armstrong race in an epic battle to the top against Marco Pantani. It was dramatically commentated by two other legends of the sport, Phil Leggett and Paul Sherwin. They set the scene and framed the medieval history of Mt Ventoux to the television viewing audience in a way that captured my imagination and stuck with me ever since. I finally got around to making it happen this summer. It was surreal to arrive in France and see the peak of the "Beast of Provence" for real with my own eyes after "seeing" it in my mind all these years! Needless to say, it was a long and hard climb for me, a formidable challenge. In my training I left 10% for Mt Ventoux and boy-o-boy that last 10% was HARD, making it ever so sweet when I finally reached the top. Upon reflection of the whole event afterwards, I can say that there are a lot of parallels between the Mt. Ventoux experience, entrepreneurship and working in biotech product development. Some nuggets of wisdom and virtues with relevance include: having a vision and goal; believing in yourself; staying focused; staying the course; being dedicated; rising to the challenge; facing and overcoming adversity & obstacles; having GRIT!; keeping your eye on the prize!; being scared and doing it anyways!; persevering; being patient; seeing the long game; the sweetness of success; putting in sustained effort; getting back on the horse when you fall off; working through pain; taking stock and looking behind once in awhile to see how far you’ve come!; honing your craft; working hard, …the list goes on!… In sport, as in business, relationships and LIFE! So, here’s to the big goals, dreams and aspirations that each and every one of us have!! There are reasons for them!! WHAT ARE YOURS?! I would love to hear, so share here! It is a gift to have them, may we all have the courage to pursue them! Go for it!

Hi all, I am looking for two lab analysts to work in Western Canada. If you or anyone you know is interested in finding out more info, please DM me. #collaboration #gmp

Nick Healy Looking forward to BIO 2024, and to seeing friends and colleagues next week! #collaboration #gmp

xCellarate Technology Consulting Inc. is pleased to be attending BIO 2024 in San Diego next week with colleagues and friends including strategic partner Brian Tham! The calendar is filling up 👍 You know what to do, let’s get together! #biopartnering #collaboration #community

In addition to the extraordinary advancements being made in C/GT, there are also the ongoing challenges and complexities….

xCellarate will be attending! Looking forward to planning and scheduling meetings with friends and colleagues old and new! DM me with your plans and we’ll meet up! #biotech

Here is the very recently issued FINAL FDA guidance document on CAR-T cell product development! When the DRAFT guidance was issued two years ago xCellarate was conducting a GMP compliance assessment of a CAR-T manufacturing site. In the 2-years since, there have been advancements on some fronts (ie. potency assay definitions) and ongoing questions/challenges on other fronts (division of/mixing of, performance verification standards in a healthcare setting vs a traditional pharma manufacturing environment). Exciting times! #cellandgenetherapy #gmp #cmc #qualitymanagement #regulatoryaffairs

xCellarate is pleased to announce the upcoming RAPS event in Vancouver! https://lnkd.in/gRZ8YfZZ