Lecture 1.

Introduction to
Bioprocess Engineering
CH148 Biochemical Engineering
Introduction
We have come a long way with genetic manipulation. For thousands of years, genetic engineering
has been practiced at the level of breeding and selection.

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Introduction
Now, genetic engineering is done in a purposeful, predetermined manner with the advent of
techniques to manipulate DNA at the molecular level.

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Introduction
With this revolution, new visions and new hopes have emerged.

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Introduction
Biological systems are very complex and beautifully
constructed, but they obey the rules of chemistry and
physics and are thus susceptible to engineering analysis.
Living cells are, to a degree, predictable—processes to
use them can be rationally designed and constructed on
commercial (large) scales.
This is the job of the bioprocess engineer.

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Biotechnology and Bioprocess Engineering
Biotechnology implies the use or development of methods of direct genetic manipulation for a
socially desirable goal, examples of which are:
• production of a particular chemical
• production of better plants or seeds
• gene therapy
• use of specially designed organisms to degrade wastes
Bioengineers or biological engineers are engineers working with biotechnology as applied to
medical and agricultural systems. It is a very broad field and is thought to comprise of many, more
specific sub-disciplines.
Biochemical engineers are chemical engineers who extend engineering principles to systems
using biological catalysts to bring about desired chemical transformations. Biochemical engineers
may be either bioreactor engineers or bioseparations engineers.
Biomedical engineers apply engineering and biological principles to medicine and healthcare,
mostly focused on the development of biomedical devices or implants.

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Biotechnology and Bioprocess Engineering
Also, there is a difference between bioprocess engineering and biochemical engineering.
Biochemical engineers may be thought of as mainly interested in the analysis of biological reactions
and the design of suitable bioreactors, whereas bioprocess engineers would include the work of
mechanical, electrical, and industrial engineers to apply the principles of their disciplines to whole
processes centered on bioreactors.
The problems of detailed equipment design, piping, sensor development, control system design,
control algorithms, and manufacturing strategies utilize principles from these disciplines.

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Biologists and Engineers
The fundamental trainings of biologists and engineers are distinctly different.
In the life sciences, most progress has been due to improvements in experimental tools;
mathematical theories and quantitative methods have played a secondary role. Results are
qualitative and descriptive models are formulated and tested.
Consequently, biologists are very strong with respect to laboratory tools and the interpretation
of laboratory data from complex systems.
In engineering, there is emphasis on the physical and mathematical sciences. Theories lead to
mathematical formulations, and the validity of these theories is tested by comparing predicted
responses to those in experiments. Results are quantitative and modeling of even complex systems
is a strength.
Engineers are typically unfamiliar with the experimental techniques and strategies used by life
scientists, but are able to perform complex mathematical procedures as needed in support of
hypotheses.
The skills of the life scientist and engineer are complementary; bioprocess design involves both.

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 A broad range of
disciplines is involved
in bioprocessing.
Scientists working in
this area are
constantly confronted
with biological,
chemical, physical,
engineering, and
sometimes medical
questions.

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Alexander
Fleming,
discoverer
of penicillin

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Regulatory Constraints
Every country’s FDA must ensure the safety and efficacy of medicines. For bioprocess engineers
working in the pharmaceutical or biotechnology industry, the primary concern is not reduction of
manufacturing cost, but the production of a bioproduct of consistently high quality in amounts to
satisfy the medical needs of the population.
FDA approval for a product, including its production process, takes a lot of time and money. Pre-
clinical testing must be done in animals before human clinical trials start.
There have been tragic examples where a small process change has allowed a toxic trace compound
to form or become incorporated in the final product, resulting in severe side effects, including
death.
Thus, even slight process changes may require new clinical trials to test the safety of the resulting
product. Since clinical trials are very lengthy and expensive, process improvements are made under
a limited set of circumstances.

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Regulatory Constraints
Drugs sold on the market or used in clinical trials must come from facilities that are certified as
GMP – Good Manufacturing Practice.
GMP concerns the actual manufacturing facility design and layout, the equipment and procedures,
training of production personnel, control of process inputs, and handling of product. Equipment
and procedures (including cleaning and sterilization) must be validated. Even computer software
used to monitor and control processes must be validated.
Offline assays done in laboratories must be certified as GLP – Good Laboratory Practice.
Procedures are documented by SOPs – Standard Operating Procedures.
The actual validation procedure is often complex, particularly when a whole facility design is
considered. The key point, however, is that process changes cannot be made without considering
their considerable regulatory impact.

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 Lecture 1.1

Introduction to
Bioprocess Engineering
CH148 Biochemical Engineering
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