My former research career was spent in academic laboratories, and I don’t have first-hand experience in the world of bioprocessing. However in my current job as a science writer/copy editor, I create product information and literature about products that are useful to bioprocessing engineers and technicians, and thus wanted to learn more about this diverse area, where discovery and processing of biomaterials results in better therapeutic drugs, better biofuels and even healthier foods.
Bioprocessing is a combination of biological science and chemistry, and a burgeoning science field. Burgeoning is an understatement. Exploding is a much more apt description.
This 2011 Science magazine careers article defines bioprocessing thusly:
“Bioprocessing is an expanding field encompassing any process that uses living cells or their components (e.g., bacteria, enzymes, or chloroplasts) to obtain desired products, such as biofuels and therapeutics.”
Today, late in 2016, bioprocessing includes the rapidly growing area of nutraceuticals (isolation of beneficial compounds from plants such as polyphenols from cacao; here is a 2016 cacao reference.
A more mature area of bioprocessing, biopharmaceuticals, specifically immunotherapeutics, has advanced to the stage of post-clinical-trial/in-the-pharmacy immunology-based drugs. Immunotherapeutic drugs have saved lives from cancers such as melanoma (see former President Jimmy Carter’s story ).
Bioprocessing encompasses a wide and growing world of products. There are a wide variety of types of jobs in the growing fields of biofuels, biopharmaceuticals and nutraceuticals, and for the scientist that wants to help make the world a better place, opportunities exist at educational levels from associates’ degree to PhD-level work. (See the links at the end of this article to learn more about careers and training available in bioprocessing.)
Biopharmaceutical development is divided into several preclinical stages, when discussing identification and development of new compounds (new chemical entities or NCEs) for use as therapeutic drugs. Bioprospecting or identification of compounds with activity against a particular target is the first stage. This involves first compound isolation, then screening of thousands to hundreds of thousands of compounds for activity against a specific target.
In the next phase, early drug characterization, a smaller number, let’s say tens to hundreds of compounds that showed the desired activity on initial screens, are further evaluated using liquid chromatography and mass spectrometry (LC/MS), to analyze their chemical composition, safety profile, and to examine compound pharmacokinetics in vivo. This characterization narrows the potential drug candidate list further.
Then the drug candidates with suitable safety profiles move to another specialized group, the process development scientists. These scientists determine the optimal ways to manufacture the selected drug candidates. Extensive method development, testing and documentation characterizes the process development scientists’ work. Their rigorous testing and protocols helps determine how the drug will be dosed and used going forward.
Development of a therapeutic antibody follows a similar lengthy and careful development, albeit a separate process. Here, protein characterization and modification are required to produce immunotherapeutic drugs.
In this process an antibody producing cell line, such as CHO (Chinese Hamster Ovary) cells are treated with the antigen of interest (e.g., a tumor antigen) during cell culture, or by transfection of nucleic acid into the CHO cells, in order to generate antibodies that are specific to or target that antigen. The cell supernatant is then collected and the antibodies isolated.
Next, the antibodies are characterized to determine attributes including the protein sequence, in particular the sequence for the portion of the antibody (immunoglobulin or Ig) that is specific for the target. Once this sequence is identified, it can move to large-scale production and purification, optimization, safety profiling, as well as pharmacokinetics and dosing studies.
At Promega, we are continuously producing products for the processing and characterization of antibodies (and other proteins). For instance magnetic affinity beads, Magne® Protein A and Magne® Protein G Beads and High-Capacity Streptavidin Magne Beads are available for use at variously-sized scales for antibody capture.
For protein characterization, IdeS Protease and IdeZ Protease can be used to cleave Igs at specific sites, enabling antibody characterization and preparation for mass spec (see figure). The special trypsin formulation, Trypsin/Lys-C Mix, is designed for peptide mapping and to prepare protein samples for liquid chromatography-mass spec (LC/MS) analysis. And an exciting new trypsin will be available early in 2017 for improved prep of antibodies for mass spec.
If you have a particular interest in our latest trypsin formulations, they are available from Custom Assay Services at Promega. See the CAS website for more information.
You’re interesting in making a difference, in making the world a better place through your scientific research studies, whether with new drugs, or better biofuels. We want to help you achieve your research goals.
To learn more about the general field of bioprocessing and related careers, see at the Biotech Careers page.