mobius single-use manufacturing

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In addition we recently launched the Millipak Final Fill Filter for high-value small-volume processing and the Mobius Power MIX 2 500-Liter and 3 000-Liter large-scale single-use mixers Another new solution Merck has introduced to the bioproduction process is the Viresolve Barrier capsule filters which are used to protect against bioreactor contamination The Allegro single-use mixer biocontainers are leak tested at manufacture All Allegro biocontainers including the mixer are manufactured in a controlled environment (Class 10 000) certified to ISO 13485 and ISO9001 The materials of construction of the Allegro mixer biocontainer meet: USP88 Biological reactivity test In Vivo for Class VI - 50 C Plastics USP87 Biological

Process Design for an All Single

• Manufacturing experience with multiple single-use vendors and equipment Chrom Skids Pre-packed Columns Single Use TFF Skids Single Use Mixers GE AKTAReady GE ReadytoProcess Pall SU TFF GE XDM / XDUO Repligen Opus Sartorius FlexAct Sartorius Palletank Millipore Mobius Downstream Learning from Early Adoption • Design Limitations – Skids: flow rates mixing temperature control

Mobius€Power MIX 2 500-Litre and 3 000-Litre€large-scale single-use mixers "The biopharmaceutical industry needs flexible manufacturing solutions that reduce long drug development timelines and accommodate shifts in demand while protecting employees and the environment " said€Andrew Bulpin head of the Process Solutions business unit Life Science at€Merck €"Merck's new

As a full-service RD and manufacturing company we are committed to: OR/Mobius RUMI II single-use intrauterine tips are available in six sizes to accommodate individual patient anatomy Made from flexible silicone RUMI II tips have a soft flexible distal end to reduce the risk of uterine perforation and trauma Their strength and flexibility allow the intrauterine balloon to be

Scalable Simple Smart and Reliable Mobius Single-Use Bioreactors are a scalable portfolio of stirred tank bioreactors that provide flexibility by configuring software hardware and single-use assemblies for use in fed-batch and perfusion applications The Mobius Bioreactor family includes the bench scale (3 L) pilot-scale (50 L and 200 L) and clinical scale (1000 L and 2000 L

Coupling the drive unit with single-use mixing systems and their containers is simple and quick to complete The Magnetic Mixer utilizes single-use mixing biocontainers made from Allegro™ TK8 bioprocess film The product-contacting layer of Allegro TK8 film is blow-extruded in-house by Pall Life Sciences under cleanroom conditions It is then laminated to create a gas barrier film of

Bioprocessing of human mesenchymal stem/stromal cells

Mobius CellReady (EMD Millipore) requirements of a particular manufacturing process Other single-use technologies which have been established for many traditional cell-based recombinant protein manufacturing processes can be readily applied to regenerative medicine applications such as containers for preparation of media buffer and microcarriers customizable storage and transport

May 01 2017: MilliporeSigma's Mobius 2 000-liter Single-use Bioreactors to Expand Avid Bioservices' Manufacturing Capabilities 50 01/20/2016: Peregrine Pharmaceuticals to Present at Two Upcoming Cancer Immunotherapy Conferences 51 Clinical Trials 53 Nov 14 2016: New Study Demonstrates Anti-Tumor Advantages for Combination Treatment Featuring Peregrine Pharmaceuticals PS-Targeting

Mobius Choice Single-Use Assemblies Next higher product group: bioreactor disposable: Status: 2017-03-21 sales start Organisation: Merck KGaA : Group: Merck (DE) (Group) Merck KGaA (3/21/17) Press Release: Merck Introduces Mobius MyWay Portfolio for Customized Single-Use Assemblies Darmstadt New portfolio provides shorter lead times for more rapid biomanufacturing Optimizes

The client is upgrading its manufacturing facility in Basel with five of Merck's Mobius single-use bioreactors with 50 200 and 2 000-litre bioreactors to augment its development and manufacturing capabilities "Merck is providing five of its Mobius single-use bioreactors to the contract development and manufacturing organisation Celonic " It is expected that this upgrade will expand

2 Mobius Standard Assemblies Mobius standard assemblies are convenient single-use solutions for a wide range of biopharmaceutical applications such as formulation processing of sterile fluids or buffer and storage The assemblies are animal-derived component free and delivered pre-sterilized by gamma irradiation ready to use in your existing processes—

Single use technology -Where in Vaccine Process Media Preparation Fermentation/ Cell Culture Cell Harvest/ Clarification Formulation/ Sterile Finish Fill Compounding Filtration Buffer Preparation 6 Aseptic Applications for Disposable Technologies • Sampling – Aseptic sampling of bioreactors and other sterile vessels • Aseptic product transfer – Transfer of fluids from vessel to vessel

In addition we recently launched the Millipak Final Fill Filter for high-value small-volume processing and the Mobius Power MIX 2 500-Liter and 3 000-Liter large-scale single-use mixers Another new solution Merck has introduced to the bioproduction process is the Viresolve Barrier capsule filters which are used to protect against bioreactor contamination

People often confuse the 'resin identification code' for the general recycling symbol (mobius loop) which looks like three chasing arrows Paper and cardboard Such as office paper envelopes pizza boxes egg cartons newspaper and magazines Cardboard milk and juice cartons This material is also called liquid paper board Glass bottles and jars Such as sauce and jam jars and soft drink

Plastic

Hard plastics coded 1–7 can be recycled in the yellow lidded recycling bin except for polystyrene and plastic bags People often confuse the 'resin identification code' for the general recycling symbol (mobius loop) which involves three chasing arrows Plastic bags Twenty million Australians still use over 3 9 billion plastic checkout bags

• Prove the safety of the single-use system and approve it to be used within your manufacturing process • Identify the need for a process change You will receive a report with data supporting this outcome • Mobius Validation Services tech brief TB10010000 • Extractables and Leachables for Filters Bags and

manufacturing Validation of single use systems 2 Overview of SU Products •SU products –Single use containers or bags for storage and sampling –Filter assemblies with tubing (silicone and /or C-Flex) –Non-sterile and sterile connectors –Disposable mixing system for solution preparation and formulation –Final filtration assemblies for final filling –Single use systems 3 Film

This is critical to customers from contract manufacturing organizations to big pharma whose biggest challenge is getting custom assemblies with fast reliable lead times for quicker turnarounds and more rapid biomanufacturing For commercial manufacturers Merck's Mobius() MyWay portfolio helps minimize schedule disruptions and delays Pilot plants benefit from faster assembly design and

Our set up involves Sartorius DCU with disposable 3L Mobius bioreactors as well as 5L 15L and 50L from New Brunswick/Eppendorf With a productivity between 2-5 g/L a 50 L bioreactor run can yield up to 250 g of protein which is often sufficient to support pre-clinical and toxicology studies in animals Downstream process development is conducted in parallel by generating feeds at 1-3L

MSC propagated in the single-use 3 L bioreactor (Mobius EMD Millipore) for five days with a 5 2-fold increase in total cell number from 30 to 150 million cells Similarly BM-MSC were propagated in a disposable stirred tank bioreactor (Mobius CellReady 3 L bioreactor Millipore) achieving viable cell densities of 2 5–2 7 10 5 cells/mL during 12–14 days of culture [ 51 77 ]