Battelle: A One-Stop Shop for Biological Formulations

Editor’s note: ″As an organization, Battelle boasts over 20 years of experience in formulation development. Many of our experts bring at least 40 years of industry experience to this area. This translates to deep knowledge and a proven track record in this field. Moreover, we are constantly dealing with different projects on biologicals and are in direct contact with different co-formulant suppliers. As we collaborate with major co-formulant suppliers, this keeps us at the cutting edge with the latest co-formulants and additives that exist on the market. We constantly update our internal database as these products get listed in public databases, for example, OMRI″ said Dr. Lav Sharma, Battelle's Researcher and Microbial Formulation Expert in a recent interview with AgroPages.

During this interview, he also shared his views on Battelle's resources and capabilities in biological formulation development and testing, Battelle's fermentation capabilities to produce microbes, the most significant challenges of development of microbial formulations and Battelle's countermeasures, a case study of a biological project, Battelle's competitive advantages, the regulatory and lab testing considerations when bringing a new biological formulation to the market, ways to assist companies in developing biological formulations and collaboration models, etc.

Dr. Lav Sharma

Battelle’s Researcher and Microbial Formulation Expert

What are the different biological substances used in agriculture?

Biological substances used in agriculture can be living microbes (e.g. bacteria, fungi, or viruses), materials produced by microbes (e.g. viroids, peptides, or metabolites), semiochemicals (e.g. plant hormones or insect pheromones), or natural substances (e.g. algae, root extracts, mRNA, fermentation broths and/or by-products). They have a wide range of functions such as biopesticides, insect repellents, attractants, mating disrupters, or as plant stimulants, or fertilizers.

What is Battelle’s formulation development and testing experience for these types of biologicals? 

Battelle has been formulating and testing various forms of biologicals for more than 20 years and has dealt with a wide variety of active materials. Client satisfaction has been our top priority and with biologicals, we strive to meet the same standards as we have maintained in formulating conventional agrochemicals. We have been engaged with different companies and startups across the globe and addressing their demands has made us continually improve our capabilities for formulating biologicals over the years. 

Within biologicals, do you see a specific demand from your clients that stands out? What are the current trends and innovations?

The development of products containing microbes stands out in terms of client demand. As the market for biological formulations in agriculture has been growing at a significant pace across different continents, all major agrochemical companies want to capitalize on this opportunity. In parallel, many start-up companies are emerging in this sector. The support from government funding agencies has also helped in the development and growth of these startup companies. 

In terms of function, biopesticides, biostimulants and biofertilizers are the top demands. Companies are particularly looking to develop products with co-formulants that are suitable for use in both organic farming and conventional farming. 

The near exponential growth in the development of these types of products comes, in part, from the European Commission targeting the use of chemicals in agriculture. In June 2022, a proposal was adopted for a new regulation on the sustainable use of plant protection products. This set an EU-wide reduction in the use and risk of chemical, or conventional, pesticides by up to 50% by 2030 (Sustainable use of plant protection products (europa.eu)).

Which types of formulation are more commonly used with microbial products?

Currently, our clients ask for oil dispersions (ODs), emulsions (EWs), suspension concentrates (SCs), wettable powders (WPs), and water-dispersible granules (WDGs). However, we are able to develop other formulation types as well, if requested.

In terms of microbes, what are the different types that Battelle has formulated? Does Battelle offer any storage stability support to elucidate the shelf-life of microbes?

Battelle has developed many formulations with both gram-positive and gram-negative bacteria, and with fungi. We have proven competency with seed coatings and have successfully developed products with a long shelf-life whilst being stored at room temperature. We also have experience in developing formulations from initial concepts or by improving those already used in early experimental testing or even improving those that are currently available commercially. In some cases, we have been asked to take a commercially available product and completely change the formulation type.

In all our work, we ensure the best outcome in terms of microbial viability.

What are Battelle’s resources and capabilities to formulate biological plant protection products? 

Battelle has a fully equipped and modern microbiology lab with microbiologists who are experienced in developing agricultural products. Our microbiologists collaborate with our formulation and regulatory experts to develop the most cost-effective formulations that not only ensure good product stability and ease of use but also comply with the technical and regulatory requirements of concern to our clients, whether this is to the organic farming regulations or the EU or other States’ regulations; in effect, we can offer a truly global and comprehensive service to clients.

Can Battelle formulate biologicals for conventional and organic farming? What are the challenges posed by formulations directed at organic farming?

Yes, we do formulate products to be used for both types of farming practices. As the demand for organic farming is on the increase, it brings its own challenges, especially with the types of co-formulants that can be used. Notably, for use in the US, Canada, and Mexico, a product used in organic farming must be approved by the Organic Materials Review Institute (OMRI). In addition, some customers want the co-formulants to be in the EPA 4b list. In answer to these and other inquiries, Battelle has developed and maintains a database of co-formulants that is used to inform and adapt our formulation strategy accordingly.

Does Battelle have its own library of microbes? Does Battelle have fermentation capabilities to produce microbes? 

Samples of microbes are normally supplied by our clients. We do, however, also have commercially sourced microbial strains for use in our internal research and development. We have the capability to repeatedly propagate microbes using a bench-top bioreactor and have the expertise to optimize the growth conditions where necessary. I am particularly excited because Battelle is looking to purchase a larger bioreactor for scale-up studies.   

It is true that we are repeatedly requested to culture bacteria and fungi to obtain microbial-derived active substances. This approach is highly recommended because we can then closely monitor the downstream processing to the required formulation type and use this information to provide advice on the development of the large-scale manufacturing process. This also allows us to conduct internal product quality checks to ensure that the starting materials are free from any contamination and are present at concentrations that maximize product and limit potential costs. 

Is shipping microbial samples into Battelle difficult? 

Provided that the microbes are non-pathogenic, are endemic or widespread, and are not genetically modified, then shipping live microbial cultures to Battelle’s facilities in the UK or the U.S. is relatively straightforward. Battelle has significant expertise in shipping and receiving microbial samples to or from different parts of the world.

What are the most significant formulation challenges currently faced during the development of microbial formulations? How does Battelle contribute to overcoming these challenges? 

Without a doubt, maintaining a commercially acceptable shelf-life is the most challenging aspect of formulating microbial active substances – both in the product pack and on the treated seed. Clearly, of paramount importance is to select co-formulants that will not adversely affect each species or strain of microbe, and this is also true for the formulation process. We carefully measure the initial viability of the microbes in the formulation and store products in various incubators to provide adequate stress testing. The viability of the microbes is carefully assessed again after storage.

How are different factors, such as efficacy, safety, and environmental impact, balanced when formulating microbes? 

Product safety is always a critical factor in formulation design. The co-formulants that we use should preferably have no hazard classification or have the lowest hazard rating possible, whilst maintaining efficacy of function. We also develop proposals for a production process that is efficient and produces minimal waste.

Product safety is also a critical component in product registrations. Our facilities in Havant and Chelmsford are GLP compliant, meaning that we can conduct product safety testing/studies that are globally acceptable.

Can you share a specific case study (without disclosing confidential information) of a successful biological project Battelle undertook, highlighting the challenges addressed and the positive outcomes achieved?

We undertook a project with a seed coating product where the client had great difficulty in achieving their targeted microbial load on the seed whilst maintaining the viability of a fragile gram-negative bacteria. As if this wasn’t difficult enough, the client imposed an absolute restriction to use only ″natural products″ in the formulation. We were agile enough to be able to modify our strategies by amending the composition of the powder dilution before the final application to the seed… it worked very successfully. 

In your opinion, what competitive advantages does Battelle possess compared to other companies offering similar biological formulation solutions?

As an organization, Battelle boasts over 20 years of experience in formulation development. Many of our experts bring at least 40 years of industry experience to this area. This translates to deep knowledge and a proven track record in this field. Moreover, we are constantly dealing with different projects on biologicals and are in direct contact with different co-formulant suppliers. As we collaborate with major co-formulant suppliers, this keeps us at the cutting edge with the latest co-formulants and additives that exist on the market. We constantly update our internal database as these products get listed in public databases, for example, OMRI. 

What are the regulatory and lab testing considerations when bringing a new biological formulation to the market? Does Battelle offer support in that?

Due to the complexity and variation in global regulations for biopesticides and biostimulants, a full explanation is beyond the scope of this article. However, some key factors to consider include:

Varying Definitions: The definitions of a biopesticide and a biostimulant, for example, vary around the world. Specialist advice on the regulatory and technical requirements according to the geography of where the product is intended to be marketed will need to be sought from our Regulatory Experts.

If the biological formulation is claiming control of a pest or disease, then it will generally be treated as a biopesticide and will often be subject to many of the same regulatory requirements as a chemical pesticide.

• If the biological formulation is intended for use as a biostimulant, then the data requirements will be closer to that required of a fertilizer – which are generally less onerous than for a biopesticide.

  
  

• For microbial formulations, it is important to define whether the active substance is a living microbe or metabolites produced by microbes (which may be dead or alive when formulated). The regulatory routes for these two presentations may vary significantly.

  
  

• We can conduct GLP-compliant laboratory testing to support your biopesticide, biostimulant and biofertilizer development programs. This ensures your data meets the highest quality standards required by regulatory authorities worldwide.

When it comes to biopesticides, biostimulants and biofertilizers registration, Battelle provides highly specialized, expert guidance. It is recommended that in order to identify the optimal strategy for action for each formulation, advice be sought early in the process.

How does Battelle Crop Protection Solutions assist companies in developing biological formulations? What are the different collaboration models that the organization offers?

Battelle is essentially a Contract Research Organization (CRO) conducting fee-for-service work on behalf of our clients. Collaborations normally start as a discussion, under a non-disclosure agreement (NDA), about the client’s needs and how Battelle can help. A work program is agreed upon and signed off and the practical formulation work gets underway. Where the work is well-defined, a fixed-fee project is normally set up. If the direction of the work is less certain and may need to be adjusted, based on results obtained, then a more flexible ‘Time Worked’ project program may be more appropriate. In this case, any changes in direction are fully and transparently discussed and agreed upon by both parties.

Where Battelle differs from most other CROs is that it conducts its own in-house research aimed at solving the unmet formulation needs that it sees within the industry. This can lead to improved ways of working, more efficient project delivery, and even results in the generation of protectable intellectual property. When Battelle’s research results in filing for, say, a patent on a platform formulation technology, then these are generally offered to interested clients under a license agreement. The advantage of this approach is that the client also benefits from having a patent-protected product.

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