systems gaining popularity in bioprocessing
G Somasundaram is the manager - technology
support at Millipore India.
Manufacturing plants must be able to add new products to the mix,
rapidly convert processes, and quickly make operational adjustments as
needed. These changeovers must be executed while meeting required
safety, time-to-market and efficiency goals. Many manufacturers are
implanting single-use systems to meet these deliverables, which are
gaining ground in biopharmaceutical manufacturing facilities in India
as the advantages of disposable process equipment over traditional
stainless steel process equipment become obvious.
Indian biopharmaceutical companies are now using disposable assemblies
at an ever increasing rate. Single-use technologies are becoming
available for an increasing number and range of applications, with all
its inherent advantages over traditional equipment.
Early adoption of single-use process equipment depends on the
manufacturing environments that require bioprocessing flexibility such
as in the development and manufacture of biologics. Particularly when
the unit needs to quickly accommodate new products and process
modifications. Speedy installation, startup and flexibility in
switching products are the obvious advantages for speed-to-market.
Under such conditions, manufacturers of oncology drugs and other high
value biologics are finding traditional stainless steel
equipment like storage tanks and transfer lines cumbersome because of
the amount of time taken in installing, starting, cleaning, sterilizing
and validating them. Another significant advantage seen is the reduced
risks of product contamination.
Instances of integrating single use solutions i.e plastics and existing
steel equipment, as in hybrid systems are also very prevalent in the
biotech industry as companies seek to protect their capital investments
in traditional systems. In some cases, manufacturers seeking to ensure
product safety by eliminating the risks of product cross contamination,
have moved to disposable systems completely or incorporated hybrid
solutions at critical stages in their production processes.
Single-use solutions have proved useful in facilities requiring
extensive revamping in terms of:
- Reducing the risk of cross contamination to a minimum. No
product carryover validation study.
- Reducing the risk of microbial contamination by limiting
the use of valves and manifolds traditionally used for transport of
product and buffers.
- Flexibility of movement from one product to another i.e. no
- Minimum validation prior to start up.
Mobius mixing systems have demonstrated that by reducing downtime for
cleaning validation and process engineering, manufacturers can increase
production capacity in multi-product facilities. Reduced downtime for
validation, cleaning-in-place (CIP) and sterilization-in-place (SIP)
automatically increase the number of days the production line is
available for manufacturing every month. Mobius pre-sterilized bags
have proved handy for sterile applications like sampling, transfers and
storage. NovaSeal sealing technology is a boon to securely crimp and
cut the disposable assembly into two sterile fluid paths. Sterile
capsules that are gamma-irradiated, available in a wide range of media,
membranes and sizes for flexibility, make scale-up easy while
minimizing hold-up volumes and other production losses.
Perhaps, one of the biggest concern areas in traditional processes has
been that of quick and contamination-free installation and cleaning of
fluid pathways. Piping bends, joints and on-line sampling ports are
difficult to install and clean. Single-use Lynx connectors allow the
integration of steamable hard-piped process equipment with disposable
sterile fluid paths. This results in economical, easy and reliable
sterile connections for secure transfer or sampling of sterile fluids.
Early adopters of this technology are realizing the savings accruing
from quicker installation as compared to stainless steel, the
relatively lower capital and operating costs and the tremendous savings
from lower utilities demand, particularly for clean steam and water for
injection (WFI). There are significant savings from reduced labor and
time spent on CIP and SIP.
While there are many suppliers of single-use solutions, the crux of the
problem is to get integrators and not just vendors of different
components. Companies such as Millipore address this need by partnering
the industry with the widest range of integrated solutions for
mixing/compounding, storage/holding, filtration, sterile connections,
sterile transfers and filling including the critical expertise in
validation. Validation of single-use solutions demands a different kind
of validation. Validation here, requires expertise on product
compatibility, leachables and extractables testing. The advantage of
films from companies such as Millipore is that product contact layers
are kept the same from sampling to filling systems, hence single
product contact validation study is sufficient.
A new innovation in the industry in the form of Mobius FlexReady
combines single-use assemblies (Flexware), innovative separation
devices, and process-ready hardware systems. The platform can be
wheeled quickly to wherever the process requires it and can be quickly
and safely adapted to the process requirements.
The disposable single-use technology has arrived in India. Particularly
in manufacturing environments (CRAMS) where speed-to-market, product
safety for regulated markets and flexibility are key concerns. More so
in the manufacture and development of biologics and anti-cancer drugs.