Plasmid DNA (pDNA) is used for a wide range of applications in research, preclinical and clinical studies. Most commonly known in the context of COVID-19 vaccines, pDNA serves as a starting material for the production of mRNA, but also for producing viral vectors, such as AAVs (Adeno-Associated Virus Vectors) and Lentiviral Vectors.
Using E. coli fermentation, Plasmid DNA is produced in large bioreactors to generate enough biomass to inoculate a larger fermenter, followed by clarification, filtration steps in downstream bioprocessing.
The manufacturing process is typically slow, expensive, has limited capacity, and is vulnerable to batch failure. Flexible and scalable platforms for GMP-compliant plasmid DNA manufacturing improve commercial production.
Plasmid DNA (pDNA) is a critical starting marterial during the mRNA production. Here it is important to consider controlled and reliable processes for aliquotation & filtration, freeze & thaw, ultra cold storage and shipment of your substances between the major production steps of pDNA like Fermentation, Cell Harvest and Clarification and the following mRNA manufacturing processes.
Primary Packaging
Feed Source for Aliquotation
Automated Aliquotation
Robust Protection
Controlled Rate Freezing
Cold Storage
Shipping
Store and ship anything from cell culture samples to large drug substance volumes reliably and on time. 2D or 3D single-use bioprocess containers in any size.
RoSS.PADL is a platform to standardize cooling of your single-use bag whilst gently massaging it to ensure a homogeneous mixture of your substance.
RoSS.FILL is compatible to all single use bags and bottles and can be scaled up by attaching multiple racks. Fully automated aliquoting into multiple small single use bags at highest accuracy. Applicable for cell & gene therapies, LNPs and plasmid DNA.
Accuracy is key: Fully automated platform system for aseptic filling of up to 12 single-use bags in standard configuration and is extendable to higher bag quantities. Most suitable for filling small volumes in cell & gene therapies or seed train intensification.
Single use bags with a volume of less than 250ml are covered with a first layer of soft 3D foam which is complemented by an innovative and intuitive locking mechanism. Its robust stainless steel frame protects the single use bag during freezing and shipping.
With the RoSS Shell system, the sensitive single use bag is covered in 3D foam, which is held by a highly robust plastic frame. Bottom and top are made of stainless steel – ideal for the freezeing process and absolutely robust.
RoSS.LN2F is a powerful cryogenic controlled rate freezer for temperatures down to -180°C/-292°F. An enclosed and innovative platform system for dosed freezing for cell and gene therapies enables no direct exposure, and no mechanical compressors are needed. This ensures a safe, low-maintenance and energy-saving handling.
Controlled freezeing and thawing of small batches - more important than ever for cell & gene therapies and clinical studies! The plate-based freeze & thaw platform for labs RoSS.pFTU Lab Scale is the perfect solution for one or multiple single use bags of up to in total 10L. GMP-compliant computerized system optional.
The freeze & thaw system RoSS.pFTU is a fully automated and scalable plate-based freezing unit. Both economically and in terms of product stability this cGMP compliant platform enables full control over freezing with optional connection to your MES. The plate freezer RoSS.pFTU Mid Scale is adapted to single-use bags in RoSS shells and RoSS.KSET with smaller volumes of 1L and less for a batch sizes of up to 100L.
Ultra-Cold Storage for frozen drug substances in different sizes. RoSS.FRDG keeps the desired set point temperature down to -80°C.
Storage at -80°C/-150°C & shipment. 100% protection from external mechanical influences and different possible sizes will fulfil your individualized need. Also monitoring temperature and location-tracking are no problems.
The fluid management process for mRNA, pDNA and viral vectors for cryopreservation are often performed manually and in an uncontrolled manner. As a result, they are prone to inefficiencies and increased product loss. Learn how modular and flexible single-use technologies optimize the manufacturing process in the following App Note.
