APR Nov/Dec 2022 - 76

» ROUNDTABLE
»
Briana Nunez, Lead Researcher, Sievers Instruments' Microbiology
Center of Excellence: Supply chain issues have touched many facets
of production in biopharmaceutical companies which impact the
greater market. From validating alternates sources and vendors to
increasing financial commitments to secure parts and materials,
biopharmaceutical companies have been forced to become more
dynamic. Customers in the biopharmaceutical markets have been
forced to accept longer lead times which could potentially reduce the
overall growth of their company.
Another issue that has been brought into focus by the pandemic is
hiring and staffing. Has this been a problem for the biopharmaceutical
industry? What can the industry do to alleviate this moving forward?
Treichler: Hiring and retaining staff has undoubtedly been a
challenge in the biopharma industry these past few years. Biologic
development and manufacturing requires workers to have a unique
skill set, and it can be hard to find people who are already equipped
with all the necessary skills for the job. Some of the ways that
biopharma companies have tried to address this are by partnering
with universities to train students in the skills they need when they
graduate. It has been important too to develop robust internal training
programs for new hires who may not have the full complement of skills
they will need, and will, as with any fresh recruit, require training in a
company's own individual culture, procedures and practices.
Vap: The biopharmaceutical industry struggled with hiring and
staffing for some time before the pandemic as sectors within the
industry such as cell and gene therapy were just beginning to grow
out of their infancy. With that being said, historically there has only
been a small fraction of individuals with the technical expertise
necessary to excel in these fields, making it difficult to both hire and
retain these individuals. There are now graduate programs specific to
biopharmaceutical career paths along with experienced/seasoned
individuals leading the effort to bring new cell and gene therapies
to the market. Academic institutions operate similar to businesses
in the sense that market demand needs to be present in order to
pursue a business project, or in this case a degree field; therefore, in
order to institute bachelor's degrees specific to a biopharmaceutical
career path, younger populations need to be made aware of the
biopharmaceutical industry and its function. In doing so, this has the
potential to broaden the candidate pool for hires into the cell and
gene therapy industry.
Hayden Skalski, Life Sciences Product Application Specialist for
the Sievers Instruments product line at Veolia Water Technologies
& Solutions: The biopharmaceutical industry has battled this issue
since the onset of the pandemic, and it has not been resolved currently.
High turnover rates made it extremely difficult for companies in this
industry to retain talent, especially in growing fields like cell and
gene therapy due to the rapid expansion of this sector and a growing
number of opportunities. If companies are worried about retaining
employees to get their products out to market on time, they can look
for ways to automate processes in quality control and manufacturing
departments. For example, there are numerous automated assays for
critical release tests that require less training, thus alleviating some
of the strain on staffing. As turnover rates continue to be a concern,
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companies seek to implement simpler, automated instruments where
training for departments can be conducted in less than a day.
Looking ahead, where do you see the
biopharmaceutical segment of the industry
heading in the next five years?
Treichler: I believe we will see more complexity in the types of biologics
that are being developed. Multi-specific antibodies, antibody-drug
conjugates, and antibody fusions are just some examples of complex
proteins that I believe will continue to take a larger share of the
biologics pipeline. As these modalities become more complex, it will
become increasingly important to continue to develop expertise,
technologies, and processes that will enable efficient development,
scale up, analytical capabilities, and manufacturing to bring these
therapies to patients quickly.
Vap: The accessibility and affordability of biosimilars to the patient
populations needs to be addressed. To confront
this problem,
biopharmaceutical development and manufacturing practices
need to be more efficient to control the consistency and scalability
of drug product. For this reason, the development and adoption
of continuous manufacturing and integrated software platforms
will likely be an industry focus over the next five years. Instruments,
controllers, and data warehouses need to speak the same language to
aggregate, analyze, and distribute data. Building in machine learning,
artificial intelligence, and predictive analytic capabilities will be key
to design agile operations with the ability to automatically diagnose
failures and optimize processes. With these things in mind, it will be
critical for vendors/suppliers to collaborate to enable technological
advancement for the biopharmaceutical industry with the intent of
driving efficiency gains.
Nunez: The biopharmaceutical industry will continue to drive progress
in automation, not only for efficiency, but also for data integrity.
Subjective testing versus objective testing does not require struggling
with decisions. A shortage of laboratory personnel has also increased
the interest in automation. The ability to manage many laboratories at
once, while balancing the reduced number of analysts has created a
need to lean out many repetitive tasks such as pipetting and counting
plates to decrease worker burnout.
Skalski: As the industry looks for ways to reduce human intervention
in many processes, it's safe to say that biopharmaceutical companies
will be heading toward innovative automation and pharma 4.0
concepts. Automated processes allow users to maintain a state of
control in their laboratories or manufacturing suites. Most often,
with automation comes an increase in data connectivity. In order
to lean out processes and reduce the potential for human error,
companies must assess the capabilities of their processes to analyze
data and predict/diagnose errors before they happen. Adopting new
automated technologies and implementing processes that reduce
the user footprint will be crucial in how the ever-evolving biopharma
industry adapts in the future.
APR Nov/Dec 2022

Table of Contents for the Digital Edition of APR Nov/Dec 2022
