Catalent reports that it has expanded its UpTempoSM platform process for the development and CGMP manufacturing of adeno-associated viral (AAV) vectors. The platform now includes an in-house, clonal HEK293 cell line, and off-the-shelf plasmids to support a supply chain for the development and manufacture of gene therapies, both moves put in place to reduce timelines to first-in-human clinical evaluation.
Catalent launched its UpTempo platform in 2022 to standardize protocols for cell culture, transfection, and downstream purification, as well as to implement a single, uniform bill of materials to simplify the critical supply chain and material qualification.
By adding Catalent’s off-the-shelf pHelper and rep/cap plasmids, along with a new, in-house clonal HEK293 production cell line, processes can now benefit through increased consistency and efficiency, potentially reducing the time to manufacture clinical-quality drug product to just nine months, explained Manja Boerman, PhD, president, BioModalities (Cell, Gene, and Protein Therapies).
“Speed to patients is paramount for gene therapy innovators, and as such, we’ve seen multiple customers requesting and signing up for the UpTempo platform. We are pleased to now include HEK293 producer cell line and off-the-shelf plasmids as part of the platform, enabling improved efficiency and simplicity for our customers as they prepare to enter clinical trials,” she added.
Catalent created a global network of pDNA and viral vector clinical and commercial facilities to offer horizontally integrated solutions to support advanced therapy programs from gene to clinic. Its Maryland-based network includes a viral vector development facility in Baltimore and CGMP commercial manufacturing at its FDA- and EMA-approved facility in Harmans/BWI. Production of pDNA from research grade through to CGMP quality material is carried out at the company’s European Center of Excellence in Gosselies, Belgium.
Officials at Arranta Bio, a Recipharm company and CDMO, announced that capacity has been doubled at its Watertown, MA, facility for process development services supporting RNA therapeutics. This development comes less than a year after the acquisition of Arranta Bio by Recipharm, demonstrating Recipharm’s continued focus on the advanced therapeutics market, according to David Stevens, CEO of Arranta Bio.
The expansion includes the fit-out of approximately 2,000 ft2 of lab space with flexible, modular small-scale and pilot-scale equipment to enable development and scaleup to GMP manufacturing.
The Watertown facility is an 80,000 ft2 commercial-ready GMP manufacturing facility with Grade C production suites for the end-to-end production of mRNA, lipid nanoparticle formulation, and automated sterile fill finish into vials or syringes within a gloveless, robotic isolator. The facility reportedly has capabilities for process and analytical development and GMP manufacturing for drug substances and drug products.
Recipharm completed the acquisition of Arranta in April 2022, building on its presence in the biologics market, with a particular focus on drug substance manufacturing of novel advanced therapy medicinal products.
Lonza enhanced its powder characterization capabilities at its small molecules site in Tampa. The facility has been upgraded to include universal powder flow testing alongside automated particle size and shape analysis capabilities. The addition of new instruments at the site is enabling a greater understanding of the behavior of powdered drug substances, excipients, and blends used in the development of new dosage units, according to Mark Cappucci, pre-formulation team lead, who added that the new powder flow tester can characterize powder flow properties, offering insights for pharmaceutical processing and formulation.
The tool can test samples in various states by simulating a range of powder processing conditions. Examining different aspects of a powder’s behavior can unlock a more comprehensive understanding of its dynamic flow, bulk, and shear properties, continued Cappucci. These enhanced capabilities are intended to support Lonza’s scientists and customers when filling capsules with powders and blends, both for solid oral dosage forms and inhalation drug products.
The site has also installed a new instrument that uses static image analysis techniques to characterize particles. Its capability to map the size and shape of powder particles will be advantageous when designing and manufacturing new dosage forms, noted Cappucci, who also pointed out that this upgrade will improve the evaluation of powders used in inhalers, where the identification of particle size and shape can be critical.