Eric Russell looks at the influence of internal and external drivers on biotechnology equipment development and the role of the laboratory scientist.
Equipment manufacturers develop new products under pressure from internal and external driving forces. Internal drivers include pressure from the sales department for new products to keep customers interested in the company; from the financial side, which is always looking for improved profit margins through better production methods; and general pressure for a company to keep up with the competition.
But laboratory scientists are part of the network that enforces change as an external driver. They develop new technologies that require new products to convert the experiment into a commercial offering; they either request new products or improvements to existing products so the laboratory can function more efficiently; or they bring into the laboratory commercial developments that require new equipment to implement.
Andy O'Toole, Nova Biomedical, says one change in technology that has required new products is the move from bacterial to mammalian cell culture. The pH, for example, has to be better controlled, and the company has developed its BioProfile series of analysers to meet these new needs.
This development reflects just one of the recent advances in cell culture systems that enable laboratory scientists to better circumvent problems associated with bacterial systems. These include incomplete protein expression, toxin contamination and incompatibility.
Animal cell technology also decreases considerably the total number of animals used for preventive, therapeutic or diagnostic purposes, and provides a greater potential to develop useful products.
Bacterial evaluations
Bacterial cells that have been evaluated include Escherichia coli, Bacillus subtilis, yeast as Saccharomyces cerevisiae, streptomycetes and filamentous fungi. But while micro-organisms are easier to cultivate than animal cells the latter have some useful characteristics.
Recombinant animal cells are able to modify and secrete proteins in the same way as the original sources. But in microbial systems these modifications are seldom performed completely or correctly.
In mammalian cell culture, the desired product is usually secreted into the growth media, so the cells can be removed intact, leaving behind a broth that is relatively easy to clarify.
But, in bacterial cell culture, the product is inside the cells and the cell membranes must be disrupted to remove it. The sticky nucleic acids that are released create a highly viscous mixture that can be difficult and time consuming to clarify.
BioProfile is a complete chemistry measurement system for monitoring cell culture media status (Fig. 1). This enables improved control of bioreactor chemistries leading to better product yield and quality. It significantly reduces the cost of assays, says the company.
Nova Biomedical also manufactures advanced analysers particularly for point of care and routine laboratory diagnostic testing in hospitals. The driver for the development of these products has been the demand to speed up analysis and improve efficiency by reducing the workload on a central laboratory and bringing whole blood analysis onto the ward.
This required equipment to be simple, robust, easy to learn and quick in response, which meant a different approach to design from the company's established role of producing laboratory-based equipment.
Pre-prepared plates
Improvement in efficiency has been the driver at Cherwell Laboratories where Andrew Whittard, sales director, says a growth area for the company is the pre-poured plate, supplied under the Redipor name.
Whittard says this meets the changing needs of laboratories which no longer want to pour their own plates and carry out their own quality checking. It is now more cost effective to purchase a ready-poured plate that comes with certificates of conformity and quality, enabling laboratory personnel to concentrate on other tasks.
Cherwell supplies microbiology labs which perform the routine functions of industrial analysis and environmental monitoring where agar plates are used.
This is an area when the principles remain the same but there are changes in the types of agar now available. These provide improved colour differentiation as one benefit.
The company offers over 1100 product specifications as well as dehydrated, irradiated and customer specific formulations. Support media includes Petri dish, contact plate or a variety of containers (Fig. 2).
Also seeing the effect of the improved efficiency driver, Thermo Life Sciences' Labsystems division is being asked more frequently for its Assist development. This provides a robot arm to automate its Multidrop family of high speed dispensers for microplates.
Although automation is not a core expertise for the company, these requests are a pointer to the requirements of laboratories which need accurate dispensing and high speed throughput.
Computerisation
In terms of the drivers that result from general developments worldwide, the advent of computer networking is a typical example. But that has required special software to be written for controlling and supervising laboratory systems and tasks from a central office.
Now the internet is entering the laboratory. Firstly, as a low cost way to transfer data between different sites and, secondly, as an immediate source of product information for equipment buyers.
But hopes of the internet developing as a mainstream way of purchasing goods have definitely been dented. Dotcom failures have been well publicised and confirm the findings of distribution company Camlab.
Colin Day, internal sales manager, says the company recently carried out a survey of some 500 customers on their use of the internet amongst other marketing subjects.It found that many people were accessing the company web site to survey the range of containers, refrigerators, freezers, shakers, stirrers, hotplates, glassware, washing machines and other laboratory equipment that the company supplies. But viewers were not purchasing through the internet. Buyers still like to discuss products before committing themselves and Day feels this will be the practice for a long time to come.
This finding is common to a number of companies over a range of industries. Company accountants are also concerned that the costs of setting up and maintaining a web site cannot be tied in to an increase of sales and so they cannot calculate the payback time of the investment.
But many benefits are indirect. A company should be spending less on printed brochures and also using the site to show the latest products as soon as they are available. This should mean early sales for new items instead of waiting until the annual brochure reprint to boost sales.
Day finds that laboratory personnel are a conservative breed and will only accept new products and technologies after they have been tried and tested successfully, and this could apply to use of the internet.
But internet purchasing could be changed once buying malls are established, so buyers can visit just one site to keep up to date with new products from a wide range of companies.
A change that laboratory scientists can take advantage of is the trend to create intermediate production plants between laboratory scale and mainstream production facilities.
Greg Smith, operations director of Lab-Plant, says there has been a recent upsurge of interest in kilo lab and scale up equipment. This intermediate stage between the research laboratory and full scale manufacturing has developed as a result of the huge costs of product development.
It minimises the risk that a research idea will not transfer into production, or may need substantial re-engineering to be commercially successful, by creating a pilot production plant. Lab-Plant specialises in this area with a wide range of kilo-size products and reactors in the 50100l range.
The laboratory scientist has to be aware of the potential of kilo lab production. It provides more scope for changes in a product because less capital investment is involved and there is less pressure to achieve payback.
Smaller plant also means change to capital equipment is easier, so a product could emerge from the laboratory with a number of possible variants. But there is generally not the opportunity to change once full scale production facilities have been established.
And with global trading providing an all-pervading driver, Paul Daga, a sales manager with Trek Diagnostics, says manufacturers have to match their products to the country they are supplying. In Eastern Europe, for example, wages are relatively low so automation is not as attractive a proposition.
Quality is also a variable issue around the world but this again depends on local economies. The higher the quality and accuracy, the higher the cost and laboratories have to decide the level that is acceptable for their markets.
Some countries have bought a great deal of new equipment, but cannot afford to operate it. The reason is that government grants have financedthe purchase, but running costs, such as consumables, have to come from the laboratory's revenue, which may not run to such sophistication. Trek Diagnostics is a dedicated microbiology company working to provide better solutions for better patient care.
These examples show that the laboratory scientist has a key role in shaping the products that come on to the market, either by communicating the laboratory's technical needs or its wish to develop commercially. But it is a pity that these behind-the-scenes developments by product manufacturers do not attract the attention given to developments from the laboratories themselves.
