GMP LAB CONSTRUCTION COMPLETED
Magellan has completed the construction of the GMP laboratory facility, with the emphasis now on balancing and testing systems. The installation of the Environmental Monitoring System (EMS) is largely complete.
The research and development lab is being used to evaluate Bioreactor manufacturing methods and donor cells culturing, with a range of tests to ensure consistency of the manufactured cell product to meet therapeutic and regulatory standards across the globe.
An additional Quality Control (QC) laboratory is under construction. It will allow further testing that needs to be performed separately from the R&D lab.
Our QC lab will be the only such accredited lab in Australia for this type of testing.
Laboratory benches have been installed and the first equipment has been located for the GMP laboratories, with all equipment for TGA accreditation expected to be installed by mid-November.
LAB EQUIPMENT SOURCED
We are pleased to report that Magellan has been able to source a range of GMP-standard lab equipment at a significant discount from a company which has changed its operations focus.
This purchase includes an auto pack and fill system. With a total Magellan spend of $150K, we now have equipment that would have cost in excess of $500K.
BIO 101 AND REGISTRY DIRECT ACCESS
The share registry transfer from Minters to Registry Direct via Bio 101 is complete and all shareholders will have received email details to allow access to their Magellan Shareholding details.
There has been only one shareholder query to date, so the transfer process seems to have been successful.
The aim is to use more Bio 101 services going forward to assist with other Company Secretary/administration matters. Magellan also intends to use this service to store and record Magellan reports and shareholder information for easy Shareholder access.
MEET MAGELLAN’S HEAD OF LABORATORY
Ms Nirali Shah (pictured in Magellan’s R&D lab) is one of Magellan’s key laboratory scientists.
Nirali joined Magellan eight years ago. She has taken on the role of Head of Laboratory while Head Scientist Ms Kiran Shah is on maternity leave.
“I’m excited to step into Kiran’s shoes while she is on maternity leave. I’m enjoying immensely working closely with Magellan Quality Manager David and the whole Lab team at the new facility in Braeside,” Nirali said.
PREPARATION FOR TGA VISIT
Magellan Quality Manager David Petrie and the Magellan lab staff have continued their work with Seer Pharma re the drafting of CMC/SOP documentation.
David has co-ordinated and progressed the completion of this documentation and is working with all of the lab staff to prepare for the TGA accreditation visit in December.
David and Peter Hansen have also been working with the Centre for Biopharmaceutical Excellence (CBE) to compile all of the documentation required for TGA accreditation and validation of the GMP facility.
We are happy with the progress on this massive task.
CDMO ACTIVITY
Initial concept plans have been agreed on how to add two more GMP labs to the Braeside facility, targeting external Contract Development and Manufacturing Organisation (CDMO) culturing and supply of GMP standard product to universities, government departments and other companies undertaking trials in Australia.
There is a large supply issue worldwide for such product, and Magellan will explore this market further in 2024 after it has cultured all MAG200 MSC’s for its trial.
FROM THE CHAIR
The Magellan CAB is due to meet in November to review progress and provide input on our Fundraising activities to date, assess our current prospective new shareholders and provide input into our proposed CDMO venture.
This venture will be resourced separately from our P3 trial and will not impact or cause any delays with the trial process.
The Magellan Medical Advisory Board (MAB) has been active in its input into the Osteoarthritis Phase 3 trial protocol. This lengthy document is now completed and under final review.
On behalf of shareholders, I have requested that Board members meet for a strategic discussion on the various options available to us for further capital raising.
I am very pleased with progress to date but wish to explore any and all options that can help ensure the continued success of Magellan.
Many of the lab team are now located in the Braeside facility and are attending to the process of developing the extensive range of SOPs needed for the GMP Lab operations next year.
At this stage, Magellan is planning to hold its AGM at Braeside in late December 2023 to provide Shareholders with the opportunity to join a tour of the facility.
Yours sincerely
Lou Panaccio
Chair
Magellan Stem Cells
