The preparation of process liquids and buffers for in-house bioprocessing can be complex and face many logistical challenges. Additionally, a failure to optimize operational efficiency can result in supply chain disruption, total cost of ownership (TCO) and quality control challenges.
By selecting high-quality yet affordable process-related chemicals, biopharmaceutical companies can ensure compliance, enhance workflow economy and reduce TCO beyond capital and operational expenditures.
This whitepaper highlights tailored solutions to minimize workflow costs, improve productivity and mitigate risk.
Download this whitepaper to learn more about:
Hidden costs that can adversely impact workflow speed and time to clinical trials
Managing unexpected demand, chemical shortages and supply chain delays
Solutions that can support manufacturing workflows and reduce TCO
Plan for success with your process liquid and buffer preparation.
Preparation for manufacturing is a complex and challenging
undertaking. Process liquids and buffers are important
components within the bioprocessing workflow, and
preparation of these solutions can be very resource
intensive. The fiscal impact of process liquid and buffer
preparation in the total cost of ownership (TCO) goes
beyond capital and operational expenditures. There are
numerous hidden costs associated with inefficiencies,
contamination, batch failures, and personnel devoted to
manufacturing process liquids and buffers.
Setting the groundwork for successful scale-up is essential
for getting a therapeutic to market quickly and efficiently, but
navigating the unknowns associated with this process can
be challenging. A greater awareness of common operational
inefficiencies, risks, and financial burdens can improve the
overall spend visibility to obtain a more accurate assessment
of the TCO. In addition to “known” costs such as personnel,
equipment, and physical space, TCO includes “hidden” costs
such as process inefficiencies and quality errors. Greater
visibility and awareness of hidden costs can inform how you
approach the next stages as your business expands and
your production demands increase.
Plan for operational efficiency
Sourcing from a reliable chemical supplier is an essential
component in scaling up your process liquids and buffers.
Often, several suppliers will be needed to obtain all the raw
materials required for various buffers and process liquids.
In times of chemical shortages and delays, or unexpected
increases in demand, managing the logistics of alternate
sources requires additional time and labor. Managing multiple
supplier relationships individually and coordinating inbound
material receipt can be a very resource-intensive process.
Without consolidated orders, freight and shipping expenses
will be higher, for multiple individual shipments.
Beyond procurement challenges, raw materials need to
undergo quality control (QC) testing prior to preparation for
process liquids and buffers. The documentation, validation,
and training associated with these processes also present
challenges to facilities that must allocate personnel and
equipment. Inefficiencies in any step of this process can
increase the risk of production delays.
Outsourcing process liquid and buffer preparation can
increase workflow efficiencies and support scale-up. The
right partner can help reduce total costs by managing
your supply chain and identifying compliant suppliers to
ensure quality standards are maintained when sourcing raw
materials for buffer production. With the right support, you
can mitigate supply disruptions, increase order accuracy, and
improve productivity. Depending on your scale-up needs,
the right partner can provide ready-to-hydrate dry powders
in standard or custom packaging or ready-to-use process
liquids in bioprocess containers. They can further support by
handling multiple buffer solution calculations to help reduce
risk of pH errors, performing audits, and testing multiple lots.
With extensive knowledge in liquid stability, the right partner
can confidently deliver large volumes of liquids and buffer
concentrates suited for your needs. With larger batch sizes,
QC testing can be consolidated, further increasing
Mitigate your risks
When handling chemicals, you must comply with and adhere
to Environmental, Health and Safety (EHS) regulations. Buffer
formulations that include corrosive or hazardous chemicals
require additional processes, protocols, and special equipment
that pose potential safety risks for personnel. Furthermore, the
tendency for some powders to clump or be prone to static
charge increases the labor associated with preparation and
cleanup. To reduce the possibility of cross-contamination and
particulate risk exposure, most material handling takes place
under a laminar flow hood or in a ventilated space, which
has the potential to conflict with other core activities. Manual
material handling of large drums, along with repetitive motions,
are safety risks with in-house preparation.
Misformulations and batch failures are common and can
be costly due to the waste that is generated. Identifying the
primary causes of these issues will give you visibility into
how to improve processes and reduce waste. To reduce
production delays when there is batch failure or unplanned
demand, a safety stock is often stored on-site. However,
safety stock requires sufficient warehouse space for storage
and careful management to ensure the right amount is
maintained. Additional costs can arise if too much material is
kept and expires before it is used.
Contamination and operator error are primary causes
of batch failure. Finding qualified personnel for buffer
preparation activities may require additional time and effort
due to talent shortages affecting many industries. An
experienced outsourcing partner can help ensure accurate
preparation of process liquids and buffers and reduce risks,
allowing you to allocate resources to core activities. The
right partner understands the careful calculations required to
make quality process liquids and buffers, has the expertise
to evaluate stability profiles, and can determine appropriate
packaging for chemical class.
Maximize your facility and processes
The capital investment for a facility suitable for manufacturing
vaccines and therapeutic products can range from $500
million to $1 billion . Setting up a new facility can take 5 to
10 years. If scale-up is needed, capacity is often expanded
by setting up suites in parallel or investing in equipment.
Financial loss is a risk if these facilities are underutilized.
Buffer preparation is a highly resource-intensive activity that
requires significant floor space. Buffers make up the largest
volume of downstream processing components, and thus
can be challenging to store . Outsourcing process liquids
and buffers and utilizing in-line dilution (ILD) technologies
can help reduce your resource and space constraints while
reducing capital costs. Although tank volumes are reduced
with concentrated buffers and ILD, the overall number
of tanks remains the same and the floor space required
to house those tanks will always be a capacity limitation.
Outsourcing buffer preparation can help biomanufacturers
save time and reduce or avoid capital expenditures.
Biomanufacturers can then consider investments in
resources and activities to help scale growth.
Preparing process liquids and buffers requires personnel
who are experienced in handling large liquid volumes
and pre-blended powders. When talent shortages are an
issue, hiring a qualified team may be challenging. Some
facilities are unable to divert personnel for buffer preparation
activities and find support through outsourcing. Outsourcing
to an experienced partner can provide qualified personnel
who work as an extension of the team.
There are opportunities to assess workflows for areas for
potential improvement by conducting a Gemba walk. The
right outsourcing partner will have lean specialists that can
work directly with front-line personnel to identify areas of
waste, risk, and value to develop a plan of action to eliminate
key pain points and increase efficiencies. Depending on
needs, they can provide the facility space and skilled staff
to create quality buffers offsite for just-in-time (JIT) delivery.
When buffer preparation is outsourced, facilities can devote
personnel and equipment to high-value core activities
Preparation of process liquids and buffers shifts resources
away from core activities. The weigh-dispense-hydration
process is filled with inefficiencies, risks, and failures that can
increase time and costs across your workflows and result in
production delays. Setting a strong foundation to establish
a scalable process for buffer preparation while navigating
the myriad resource challenges from time, personnel,
investments, and space can be a daunting task.
Outsourcing buffer preparation to an experienced partner like
Thermo Fisher Scientific helps ensure accuracy in formulation
and consistency to minimize risks in your weigh-dispensehydration workflow. The lean specialists at Thermo Fisher can
provide key insights across your process workflow, reducing
your need for large capital and operational expenditures. The
process liquid and buffer preparation chemical specialists
will help you improve efficiencies and ensure accuracy of
your buffer formulations so you can focus on producing lifechanging therapies.
• Batch failures and unplanned demand
• Variable production schedules as a result of
• Delayed timelines to accommodate desired growth
and production increases
• Change notifications and MOC from suppliers
• Resources, time, and space required to support
supply chain and product pre-production activities
• Managing multiple suppliers and shifting lead times
• Long durations from product receipt to
• Excessive safety stock volumes that reduce
• Difficulties with product supply planning, poor
on-time-in-full (OTIF) performance, and JIT
• Significant capital expenditures on raw material and
safety stock inventory
• High overhead costs for personnel not directly
involved in quality and manufacturing activities
• Inefficient capital expenditure in warehouse space
• High operating expenses for preparing chemicals to
be used in manufacturing
• High supply chain management operational expenses
A clinical-stage biotherapeutics company faced challenges in
scaling its manufacturing operations with existing resources
to expedite development of its SARS-CoV-2 immunotherapy.
To support the desired rapid pace of development, the
company had decided to outsource manufacturing of
10 different buffers. However, the company received delayed
communications regarding lead time issues and any small
volume (<200 L) requests from the supplier. As a result, the
company faced the following challenges:
• Operational inefficiencies in the weigh-dispensehydration suites while preparing buffers, causing delays
• Inefficient supply chain and lack of communications
regarding poor lead times, affecting planned
• Warehouse was over capacity and unable to support
storage of buffers; a 10,000 ft2
expansion would be
needed to support the scale-up
There was a strong possibility of delay in first-in-human (FIH)
trials; thus, management sought alternative partners who
could reliably supply the outsourced buffers to advance the
development of their product without incurring additional
capital (CapEx) and operational (OpEx) expenditures.
Thermo Fisher collaborated with the company’s Chief Scientific
Officer and Purification Manager to better understand the
unique needs for their highest-priority buffers. Premade
process liquids ready to use in manufacturing offered the best
solution for this situation. By partnering with Thermo Fisher,
the customer received premade buffers through Thermo
Scientific™ Process Liquid Preparation Services.
Brought to you by
Download this FREE Whitepaper below
Information you provide will be shared with the sponsors for this content.
Technology Networks or its sponsors may contact you to offer you content or products based on your interest in this topic. You may opt-out at any time.