David Blicq  dblicq@rrc.mb.ca  update (05/15/2013)     DIRECTORY I BIO I NOTICE BOARD

When a new employee enters the field of biosciences, often their focus involves a particular processing area or step. This course is intended to provide an overview of some of the many job functions in an industrial biosciences setting so that the new employee sees their responsibilities in the context of the entire process.

While a comprehensive understanding of all aspects of bioscience is clearly difficult to achieve, a sound knowledge of how the various systems operate together is valuable in many different settings. Although many individuals have the necessary technical skills to contribute through specific job functions, it is through the understanding of the various responsibilities which can empower a technical employee to make exceptional contributions.

As part of the introduction, let's examine a few basic questions:

Q: Just what is industrial bioscience?

Industrial bioscience is the production, control, development and maintenance of processes to produce the many products of biosciences. Often of biological origin, these materials can be sensitive to both contamination and degradation during processing. Controls are especially important since the final products of biosciences / technology are often intended for direct human consumption. Many different tools are used (from the bench top laboratory to the industrial warehouse), many new technologies are commercially applied and new products / processes are continually being developed. Employment in the field of industrial biosciences can often require an individual to "wear many hats" and incorporate many activities into otherwise "routine" procedures.  Industrial bioscience represents a dynamic union of scientific technology and commercial enterprise:  there are many opportunities for enthusiastic, qualified people to develop and use their technical skills in a variety of challenging environments.  

Q: What are some of the products of bioscience?

The range of products which can be described as "industrial biosciences" is large indeed. Some of the products which could be described as products of bioscience might include:

	antibiotics / antimicrobials that stem microbial infections
	extracts of high-activity enzymatic preparations (for diagnostic kits / automated analyzers ELISA's(enzyme-linked immunosorbent assays)
	pharmaceuticals, medications and other drugs
	the development  and amplification of genetic materials / products
	nutraceuticals / vitamins or other health supplements
	specialized reagents/chemicals
	novel plant products / phenotypes, pesticides,
	"simple" food / agricultural products and commodities

These products are often referred to as "value-added products" since their source materials are often of lower-value (such as "raw" agricultural commodities). Through diligent processing, purification and treatment these products gain considerable economic value and are used for many specific applications.

Obviously, there is an enormous range of products which fall under the umbrella of industrial biosciences, and the list continues to grow. Despite this apparently wide diversity of different bioscience products there are striking similarities between what can appear (on the surface) to be quite different industries. The manufacture of all these bioscience products requires a high degree of process control, solid management skills, extremely accurate record-keeping and considerable process maintenance to ensure rigid quality standards are reached during production.

Q: What does management want from new technicians / employees?

A: Management wants employees to join their team and make real contributions as quickly as possible. The longer / more intensive the training (for a given employee), the greater the "downtime" and "overhead" costs (for management). With a better understanding of system interactions and technical roles a new employee is positioned to begin making "real contributions" as soon as possible.

Q: Why should a new employee acquire an overview of the regulated bioscience environment?

A: Typically, a new employee is assigned a specific job function: make specific buffer; analyze specific samples. There is a high degree of focus but a lack of understanding of the system as a whole! The new employee might well wonder:

	Is all this training necessary when I already have considerable technical skills?
	Why all the concern over my records / record-keeping?
	Why are there so many second-party sign-offs? Don’t they trust me?
	Why not take a few obvious "shortcuts" to simplify a procedure?

These very questions (seen in the context of the bioscience industry as a whole) have concrete answers that are not obvious without a knowledge of how the production, analytical and quality functions work together. While all potential employees who merit an interview likely have adequate technical skills, management often prefers team-oriented individuals who perform well with or without supervision who posses a combination of technical prowess, systems awareness and any valuable peripheral skills such as computer proficiency.

Three Major Areas of Focus:

This course will examine the industrial bioscience production environment as being composed of three major areas of activity (although each area can certainly be further subdivided depending on the nature and requirements of a specific process).

These three general areas of responsibility include: Production (manufacturing); Analysis and Quality Control. There a distinct fourth area of activity: Research and Development which interacts with all three major functions to meet specific needs. These three areas are highly inter-dependant:

     

All of these "entities" must continuously interact to ensure that high quality products are produced both consistently as well as predictably with minimal variation. This includes establishing (and adhering to) strict timelines, maintaining the quality of incoming materials and outgoing products and the monitoring of quality targets at various stages of the manufacture process. As well, it is the responsibility of individuals working in each of these areas to help ensure that a high level of accountability / traceability is continuously maintained throughout the manufacturing procedures.

Although each of these areas (production, quality control, analysis) may have quite different specific responsibilities, they are inseparably linked to one another - each interacting on many levels.

Lets continue by examining these three significant areas of responsibility in a little more detail. We will examine some of the tools, responsibilities and considerations for each area.