Catalent, the chief in enabling the event and provide of higher therapies for sufferers worldwide, at this time introduced that it has expanded its built-in growth, manufacturing and provide answer, OneBio® Suite, throughout a spread of biologic modalities, together with antibody and recombinant proteins, cell and gene therapies, and mRNA. The launch of the expanded providing will coincide with Catalent exhibiting on the BIO Worldwide Conference (sales space 785), which takes place on the Boston Conference & Exhibition Middle, from June 5-8, 2023.
Initially launched in 2019 for early-phase protein remedy growth, OneBio Suite affords clients an built-in service to speed up applications from growth to manufacturing, together with fill/end and packaging, and help for scientific provide and business launch. Underneath the newly expanded OneBio providing, clients will proceed to profit from an built-in contract and proposal, harmonized mission administration, a worldwide growth and manufacturing community, and various experience, now throughout biologic modalities and repair choices.
“Since its launch, now we have been in a position to reveal how useful the OneBio built-in biologics growth answer could be to sponsors, saving them time on managing a number of companions, and handoffs between firms,” stated Karen Flynn, Catalent’s Interim President, Division Head for BioModalities (Cell, Gene and Protein Therapies). “By increasing these companies throughout a number of biologic therapies, Catalent is providing clients the chance to leverage its end-to-end capabilities in these areas and speed up their applications to the clinic and past, mitigating potential dangers and delays by offering planning efficiencies, an built-in contract, streamlined mission administration help, and harmonized high quality programs.”
And for early-stage clients that have to develop and/or optimize their course of in direction of GMP manufacturing, Catalent’s OneBio providing will embrace multi-modality, turn-key platforms aimed to supply velocity to scientific trial provide underneath the UpTempoSM model.
On the BIO Worldwide Conference, Carey Connelly, Ph.D., Catalent’s Senior Director, Course of Improvement, will current ‘One-Cease Built-in Viral Vector Platform for Velocity to Clinic’ on Tuesday, June 5, from 11 a.m. – 11:20 a.m. on the BioProcess Worldwide Theater. In her discuss, Dr. Connolly will the built-in companies inside the UpTempo AAV growth platform and using standardized protocols for cell tradition, transfection, and downstream purification to save lots of time, in addition to the benefits it now has with an in-house, clonal HEK293 cell line, and off-the-shelf plasmids to help a strong provide chain. Initially launched in 2022, the UpTempo AAV platform was expanded in March of 2023 to incorporate Catalent’s personal HEK293 producer cell line and off-the-shelf plasmids, together with pHelper and rep/cap. Further UpTempo platforms will comply with for different modalities.
Catalent specialists will likely be out there to debate different current developments throughout the Biologics section, together with high-speed syringe filling line investments at its websites in Anagni, Italy, and Bloomington, Indiana. As well as, Catalent Biologics’ European drug product community additionally not too long ago noticed the completion of upgrades to its web site in Limoges, France, making it the corporate’s European center-of-excellence for early-phase scientific and small-scale business biologics formulation growth and drug product fill/end.
To search out out extra about Catalent’s actions at BIO, go to https://www.catalent.com/occasions/2023-bio-international-convention/ and to seek out out extra about OneBio Suite and the UpTempo platform, go to https://biologics.catalent.com/.
