Product Packaging

Product packaging is usually considered from a marketing perspective only. However, it is intrinsic to the success of a microbiological control product. The final formulation needs to be packaged in an appropriate package. The packaging material needs to be compatible with the formulation and its shelf-life. Registration requirements demand evidence hereof by means of shelf-life studies in the final packaging. Other general requirements are that the packaging be well-designed and constructed, that its content cannot escape, that it be strong and solid and will safely withstand normal handling, and that opening and closing be easy. Minimizing product contact and creating convenience to the user are other desirable elements. The material of the package needs to protect the formulation in order to maintain its shelf-life. This is important with biological products, particularly fungi, which are less stable than chemical products. Biocontrol products are more vulnerable to changes in moisture content (clumping or desiccation), oxidation and microbial contaminants. It may be necessary to keep out daylight and it needs to be air-tight to maintain the formulation's moisture level. Products could be packaged in an inert atmosphere (N2 or CO2) although I have not yet seen examples with MPCPs. In the case of EPNs, gas exchange is required, however.

Shelf-life, as defined by registration requirements, is the period that the product in the final packaging remains stable under certain conditions. Storage stability of unformulated technical product, often called the technical grade active ingredient (TGAI), and formulated product may differ, as well as the storage stability of formulated product in bulk containers versus in the final packaging. This will differ per pathogen, per type of propagule and per formulation type. Sometimes bulk storage of the TGAI or the formulated product has better storage stability than the end-use product. This will affect operational decisions such as whether, what, when, and how to store and package. In-house and distributor storage of the end-use product uses up part of the shelf-life period which is unfortunate for the end-user and this period should be kept as short as possible. Therefore, in the process of packaging, the timing of making the end-use product is related to the product's shelf-life. The actual shelf-life length determines this decision, especially when shelf-life is relatively short. For instance, DJs of EPNs are usually stored in aerated vessels before formulation. They are formulated upon demand and from this point on packaged in the commercial packaging. The shelf-life period starts here. In the case of some fungi our group has found that bulk storage is better than storage in the final package. Some formulations and pathogens have more flexibility considering this than others; thus, it needs to be approached on a case by case basis. Further, the moment of packaging depends on the frequency of production runs and the demand of the market.

Other relevant considerations to the packaging are user-friendliness, size and costs. It is easy to underestimate the costs of packaging, especially the labour component. Whether this requires manual labour or the use of costly specialized packaging machinery, these costs need to be anticipated. Other costs are cold room storage and stock management. Size and weight of the packaging should be manageable. Handling and using the package should be easy as well as (repeatedly) opening and closing, including measuring off partial amounts of the product. Marketing is an indispensible part of the game. The packaging of the product including the label must look professional instead of amateurish. The user's first impression comes from the product's appearance, i.e. the packaging. Here we are competing with the chemical industry and the image that the product produces in the customer's mind. On the other hand, the biological industry wants to emphasize that it is a biological product and not a chemical one. Biopesticides are innovative products and creative packaging offers an opportunity to deliver this message. This is a challenge for the product developer and the marketer. Rarely is the biopesticide package employed to emphasize the innovative and environmentally-friendly character of the product. The biocontrol industry has largely ignored this element. Improvements call out to be made in this area. In the development of product packaging, commercial as well as biological aspects need to be considered. Product quality and cost of packaging are key factors. Packaging is an imperative element of overall product quality in terms of efficacy, handling, economics and image.

3.3 Field Testing

Field testing the MPCA serves a number of purposes. After the strain has been selected in a bio-assay, its effectiveness needs to be studied under more natural conditions. At the same time, it is necessary to evaluate the quality of the propagules from the mass production and to develop the formulation. Further, testing is needed to determine the dose and the best application method and strategy. All these factors are interlinked and form a complex matrix. Finally, field testing needs to deliver proof of efficacy of the final product for registration purposes and for marketing purposes.

In the development of pathogens for control of greenhouse pests, testing can be done on small plants in a greenhouse setting, ranging from small plots to large blocks in commercial greenhouses, respectively from small plants to mature crops. The advantage of working in greenhouses is that testing can be done more or less year-round and climate conditions can be controlled within certain limits. There is no need for outdoor testing and thus much less need to consider variable climatic conditions and influence of rain and UV.

Considerations for testing microbials against greenhouse pests are provided by Burges (2007), illustrated by examples with Bt and L. longisporum. He focused on experimental design, infestation with pests, and spraying methods. Evans (1999) described the parameters involved in dose acquisition and relevant considerations needed on field dose rate determination, and on the importance of persistence of primary inoculum and the role of secondary inoculum. To evaluate the use of ento-mopathogens against pests, many methods can be used, depending on the microbial agent, the target pest and the crop and the environment. An excellent overview providing methods and tools for experiments with entomopathogens is given in the Field Manual of techniques in invertebrate pathology of Lacey and Kaya (2007). Several chapters focus on evaluation considerations with each of the pathogen groups, while others focus on the use of pathogens in specific systems, like greenhouse, mushrooms, nursery, lawns, etc. Particularly useful is the chapter by Chapple et al. (2007) that discusses the application of MPCPs as particulate products in relation to spray application, equipment, and dose transfer to the crop canopy. Most of their considerations are theoretical. Still, product developers need to be aware of the application variables in order to optimize formulation and application.

A vast amount of papers has been published on testing entomopathogens under semi-field conditions and, to a lesser extent, under commercial conditions. Most of these focus on a particular aspect such as strain comparison, product comparison, determination of dose, formulation aspects, influence of abiotic factors, etc. The challenge for the product developer is to integrate in a testing programme all the aspects that need to be studied to bring about an economic, effective, and user-friendly product. This testing programme should not take too long and should be affordable in terms of time and money. This requires a very good understanding of the crops, targets and the microbial product that is under development, including the delivery system. It is necessary for the product developer to have a good idea of what the ultimate product should become. Each case demands a specific approach and a good understanding of the relevant issues. Organisms with a per oral mode of action, Bt's and baculoviruses, are quite different from organisms with a contact mode of action (entomopathogenic fungi) and demand another approach. EPNs have a searching and penetration mode of action and clearly require different testing methods. An overview of testing methods for EPNs is given by Koppenhofer (2007). Most entomopathogens are sprayed on the foliar part of the crop, but sometimes they are applied to the soil. EPNs in general are soil-applied.

For all pathogens field testing is required in the development of the final product and to arrive at end-users' recommendations. A list of the essential considerations is given below:

(1) to demonstrate the suitability of the selected strain(s) in a situation mimicking as closely as possible the commercial crop. The strain selection has taken place with the help of bio-assays and must be seen as an initial phase in the selection process. Ideally, all strains are compared under more natural conditions, but that is impossible for reasons of space, time and costs. Nevertheless, this should be done with the strain or a small number of strains that were selected in the first selection phase. Testing on whole plants, or even better in a crop system, should prove that the selected strain is also effective under these conditions or that further selection between strains should be conducted. This can initially be done with propagules from laboratory cultures, but must be followed by mass-produced propagules and the formulated product. It is not possible to give detailed information on the testing methods as they vary greatly between entomopathogens and crop systems. Information can be found in Lacey and Kaya (2007), and particularly in Burges (2007) for greenhouse pests;

(2) to identify whether mass-produced propagules are effective and of good quality. Mass production must deliver infective propagules that are able to kill the target. Production on artificial media or in artificial systems may influence the effectiveness of the propagules. In the process of optimizing the mass production, many variables are studied, usually focussing on improving yield. Downstream processes may be hard on the propagules and negatively influence them. Field testing is needed to see whether the output still performs as is expected;

(3) to improve the formulation. As described above, the formulation should, amongst others, optimize application to the target and protect the pathogen after application (Jones and Burges 1998). This is true for the products based on bacteria, baculoviruses and fungi which are foliar-applied. It plays no role in the case of soil applications of EPNs, but it is relevant however for formulations which are suitable for foliar use of EPNs. Testing formulations can be done in bio-assays and in field tests or in an in-between assay, the "plant-to-tray" assay. Our group often uses this test when testing formulations, particularly when we are looking at field persistence, thus at the protecting abilities of the formulation. The formulation is then sprayed on the plant and after a variable number of days leaf discs are taken and put in the bio-assay trays on water-agar. Insects are then transferred onto the leaf discs and efficacy is assessed after the appropriate amount of time. In this way deposit of the formulated product ages under natural conditions on the plants and many tests can be done with the same deposit over time. The plant does not have to be infested with insects, only the bio-assayed leaf discs. This proves to be a simple and easy assay. But it is also important to test the formulation on plant or crop level, assessed by mortality. First, to test direct effects of the formulation such as coverage, and targeting. Second, to test protection of the propagules, and field persistence. Persistence can be strongly influenced by the relative humidity on the plant and therefore whole-plant testing is required. There may be other plant-related effects such as anti-fungal compounds or micro-flora effects, but these are more difficult to assess and generally less relevant;

(4) to determine the optimal dose and spray volume. The most important factor determined by field testing is the optimal dose. The goal is to find the highest mortality with the lowest possible amount of formulated product using the optimal application method. Application equipment should be similar to equipment used by the grower. In these tests the optimal spray volume needed to deliver the dose in the best way should also be studied, and this may vary depending on the crop and how it is cultivated. Establishing the dose is crucial to the economics of the product and it should answer the question: "can a product be developed that satisfies the grower and the producer in terms of results, and economics?" The initial data on the dose-mortality relationship originating from bio-assay tests should be followed by semi-field tests and finally confirmed by testing in commercial greenhouses with the final formulation;

(5) to determine the optimal application. This refers to the method of application, the timing of the application, the frequency of the application and intervals between applications. It actually concerns the application strategy for the product. The method of application is usually spraying with the equipment that is available to the grower. It is unlikely that growers will buy specific equipment for a new product; in that case he will choose for a conventional product. To my knowledge there is no commercial equipment specifically designed for the application of microbial products available on the market. Adoption of a MPCP will only be done if it does not require extra efforts or costs for the grower. The timing of the treatment is relevant with respect to the level of the pest and the age structure of its population and the position of the pest on the plant and leaves. Insects can be all over the plant or only on the growing top, on the underside of leaves only, in flowers, etc. This varies per pest and can be dependent on the crop. Often treatments have to be targeted at the most susceptible insect stages. Pathogens may have a slow killing activity and this may demand repeated applications with certain intervals. The optimal interval needs to be established as well as the number of consecutive treatments to control the population. This should lead to the final label recommendations;

(6) to demonstrate efficacy for registration purposes. In order to get approval for a product, efficacy has to be proven with a certain number of tests performed under commercial crop conditions and compared with a reference product. In the EU these tests are only accepted by the registration authorities when they are done according to accepted guidelines, often EPPO guidelines, and executed by GEP (good experimental practice) certified organizations. The testing has to be done with the final formulation and following label recommendations. Selectivity tests have to be performed also, showing that the product does not cause any phytotoxic effects to a variety of plants;

(7) to demonstrate efficacy for marketing purposes. Field tests will be used to show to growers, but also to distributors and sales people, that the product works in commercial greenhouses and that it fits in with all the other cultural practices. Actually, these are all demonstration trials that are not only needed to convince growers to use the product, but it is just as compelling for the company who developed the product to convince its own sales people that the product works when applied by growers on a large scale. There is always the unexpected and the unforeseen. Feedback from others, who have no experience with the product, is more than useful and can be used to improve the product and its application strategy before the product is definitively launched on the market.

From the above it is clear that a good field testing method is imperative. It should be a test that can be performed easily, quickly, cheaply, year-round and give reliable

3 Mass Production and Product Development of a Microbial Pest Control Agent Table 3.8 Purposes of field testing in product development

• Demonstrate effectiveness of selected strain(s)

• Demonstrate efficacy of mass-produced propagules

• Improve the formulation and demonstrate its effectiveness

• Determine the optimal dose and spraying volume

• Determine the optimal application strategy, incl. equipment, timing, repeated treatments and interval

• Prove efficacy for registration purposes

• Demonstrate efficacy for marketing purposes and reproducible results. Our research group has found that cucumbers can be used for several pathogens and many pests develop well on it. It germinates easily, grows quickly in various growing substrates, and it does not require specific climate conditions or fertilizers. Diseases are usually not a problem, although powdery mildew is always a risk and resistant varieties should be used. Cucumber forms a big plant in a few weeks, mimicking a commercial crop. It needs only a little labour and can be easily pruned. It also shows an intermediate sensitivity to phytotoxic effects thereby proving to be useful in testing formulation types.

Field testing consists of a series of tests, focussing on the issues that need to be studied step by step. It should be done in a logical order, as presented in Table 3.8, although frequently, one will have to go back a step and adapt or change something, e.g. in the formulation, and repeated testing will be needed to optimize a certain aspect. After this series of testing the product has been developed and the label recommendations established. With this in hand registration trials can be initiated. Field testing should give answers to all the issues mentioned above and should confirm that the final product with the right recommendations for use is an effective product.

3.4 Product Specifications and Quality Control

During the development of a product the product characteristics need to be established, ultimately resulting in product specifications. Every product batch must conform to these "specs" and product batches that do not meet the "specs" must be improved or discarded. Products need to be routinely checked on these criteria, testing methods need to be developed and a quality control protocol needs to be designed. Product specification implies a number of aspects given in Table 3.9. For

Table 3.9 Product specifications and quality control aspects

• Number of propagules or CFU's per gr or ml product

• Virulence (efficacy)

• Purity (microbial contaminants)

• Physical parameters (moisture level, particle size, etc. depending on the type of formulation)

every aspect a limit has to be set, including a tolerance range, and what measures should be taken if the limit within the range is not met. Procedures should comply with ISO working methods including tracing and tracking possibilities. Product "specs" need to be checked before product is sold. This is directly after packaging, but also after certain storage times. Product "specs" need to be set in such a way that the product still performs at the end of the shelf-life. Quality control needs to be carried out a number of times during various phases of the product. "Specs" refer to all types of intermediate products too. If "technical product" is produced and stored, "specs" need to be developed. The same holds for bulk-stored formulated product and the packaged final product. Details of quality control will be discussed in Chap. 4.

4 Production Economics and Final Product Costs 4.1 A Cost Price Model for Biopesticides

Decisive for the success of a biopesticide is its price in the market where it needs to be a good alternative in terms of costs and efficacy. If one of these two features does not meet the user's expectations, the product will not be used or used again. "Can the product be produced for an acceptable price in the market?" This essential question needs to be answered in an early stage of the developmental process. Which factors determine the costs of the product? And which factors are the main ones? I want to address these questions in general for the development of a MPCA into a biopesticide. Insight into the makeup of the end-user's price of a product highlights where attention needs to focus to render it more economical, if possible. It is also important for decisions relating to the building of a production plant, to the choice of how to produce a pathogen, to registration costs, etc. In fact it is the basis of a business plan that will lead to a "go/no go"-decision. A business plan also may be necessary to raise money.

4.1.1 Cost Factors from Production to Product

The manufacturing costs must be regarded as specifically product linked and calculations must be made like-wise. However, depending on the economic area and the structure of the manufacturer this could be evaluated in different manners. For instance, capital costs could be spread over various products depending on their stage in the market. For better understanding I will regard all costs as product-specific costs. The production costs can be divided into fixed and variable costs or into direct and indirect costs. These categories are not exactly the same, for instance, variable costs could also be sub-divided into direct and indirect costs, but for ease of use I will use the terms fixed and variable here. Fixed costs are usually expenditure for the production facility: the land, the building and the utilities, and production equipment. They also include overhead costs of the management of the business and of the plant. Production equipment includes bioreactors, downstream and formulation equipment, and packaging machinery. Facility and equipment costs are usually calculated by means of a depreciation factor, which may include a mark-up for interest and maintenance. Research and development costs can be seen as an investment because they are made before the product is launched and are therefore regarded as fixed costs. When a company has a certain permanent R&D staff, costs are seen as fixed, and part of them can be attributed to a certain product. After the product launch, research is often needed to improve the product or its use and then it is considered as a variable. In the case of biopesticides, registration costs may be a large cost factor and they can be accounted as fixed or as variable costs. Here too, they should be seen as an investment, thus as fixed costs. Later they may be some registration maintenance costs or costs for use extensions, and then they could be seen as variable. In the development phase I regard them as fixed costs and both R&D and registration are factored in as a depreciation factor. For the depreciation time a period of 5 years is taken as a generally accepted period for equipment, R & D, and registration, and 30-40 years for buildings. These periods are mainly determined by the national tax rules.

Variable costs usually include the costs of raw materials (medium and formulation ingredients) energy, fuel, water, steam, production labour costs, packaging costs and packaging labour costs. Costs for quality control and waste removal are considered variables since they depend on the production level. These fixed and variable costs differ from plant to plant, and are strongly influenced by the types of processes and products. Besides the above-mentioned production costs, other aspects should be considered such as a certain mark-up for production failures, product leftover when not sold within the shelf-life period (together called production buffer), extraordinary cases, etc. A small mark-up is also needed for a profit margin on the production (Table 3.10).

The total of the fixed and variable production costs and these mark-up factors determine the full product cost price. The costs can be calculated per amount of propagules, per product unit or packaging unit or per hectare, depending on what is the easiest for comparisons. The costs per hectare are often used in order to estimate the competitiveness in the market.

4.1.2 Cost Factors from Product to Market

The final market price further includes selling expenses and marketing costs, together called sales costs, and sales profit margins for producer and distributor. Sales costs generally comprise indirect costs, which include overhead costs, and direct costs. Indirect sales costs are administration and secretary costs, public relations and advertising costs. Overhead costs may include general administration (purchasing, financial, human resources, and ICT departments), general maintenance, management, office costs, insurance, etc. Direct sales costs are salary costs, car costs and telephone costs of sales people, travel and accommodation costs and shipping costs (Table 3.11). All these costs can be calculated on a product-specific basis or, what is often done, a certain percentage is used as a sales margin on top of

Table 3.10 Cost price model for a biopesticide: costs factors involved from production to product

Fixed costs: facility, equipment, R&D, registration, etc.

• Land and buildings

• Production equipment

• Downstream equipment

• Packaging equipment

• Registration

Variable costs

• Raw materials

• Production labour

• Packaging costs

• Packaging labour

• Quality control

• Waste removal

Fixed costs: overhead costs

• General management

• Financial administration

• Human resources

• Facilities

• Purchasing department

• General costs (insurance, legal costs, etc)


• For production buffer

• Extra-ordinary cases

• Production profit margin the full product cost price as a method to cover sales and marketing costs. Finally, the full cost is calculated for which the product will be sold to a distributor. If the product is directly sold to the end-user, the sales margin charged by the producer needs to be higher to cover the expenses which would normally be carried out by the distributor.

Often products are sold in the market by a distributor, who also makes various sales and marketing costs, and needs to make a profit on its activities. Distributor

Table 3.11 Cost price model for biopesticide: costs factors involved from product to market

Indirect sales costs

Indirect sales costs: overhead costs

• Management

• General management

• Administration, secretariat

• Financial administration

• Public relations

• Human resources

• Advertising, publicity


• Registration

• Facilities

• Insurances, etc

• Purchasing department

• Miscellaneous

• General costs (insurance, legal costs, etc.)

Direct sales costs


• Direct salaries

• Sales profit margin

• Car, telephone

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