Aptahem AB, a leading developer of aptamer-based drugs, has announced that the company is now starting large-scale manufacturing after LGC completed the Process Development (PD) work enabling larger Pilot scale production campaigns of Apta -1.
This campaign is now the first larger scale production run of Apta-1 as a non-GMP material, intended for use in GLP toxicology studies. The preceding PD work also enables LGC to manufacture Apta-1 under GMP for use in the first human clinical trial. However, continuous PD work will focus on optimisation of manufacturing cost, and to further improve process, such as yield and purity. The progress made in process optimisation is also a result of long and careful analytical development work by LGC's AxoLabs. This analytical development has been key to assess the set-up parameters necessary for the scale-up and in process control.
“We are excited to announce that the collaboration with LGC as our long-term partner to scale up production of Apta-1 for our development program, which has now reached a first milestone in production settings,” says Mikael Lindstam, CEO of Aptahem, who continues, “We will not rest at this as together with LGC we will continue to optimise the process for forthcoming manufacturing but we have now reached a good starting point.”
Thomas Rupp, Subject Matter Expert on Nucleic Acid manufacturing, CMC consultant to Aptahem, says, “Because of its highly structured aptamer nature, the manufacturing and analytical characterisation of Apta-1 proved unexpectedly challenging. LGC has utilised their outstanding experience in the field of Nucleic Acids to deliver tremendous analytical and process development work facilitating the manufacturing of the Aptahem lead compound, whilst maintaining scaleability and cost of the process.”
David Griffiths, Ph.D., Managing Director, Nucleic Acid Therapeutics Solutions, LGC, says, “Aptahem is a dynamic company and leader in an exciting and innovative field. The LGC team is delighted by the collaboration with Aptahem to develop the Apta-1 programme. Our core purpose is science for a safer world and we have applied all our specialist knowledge and capabilities to help Aptahem progress with their mission.”
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