Successful Scale-Up of New Chemical Compounds

The Shepherd Chemical Company has been providing products to the market place since 1916.  During its history, many products have been custom developed for a range of applications such as catalysts, personal care, lubricants, tire adhesion, and propellants.  The Shepherd team continually strives to achieve the intended result for the customer with the most robust technology and greatest efficiency.  In order to do this, the company has developed a collaborative process which helps to insure the customer’s needs are met from a technical and business perspective.

 

 

At the onset of the collaboration, the Shepherd Chemical team meets with the company to understand the underlying need for the development program.  In many cases, a chemical specification is provided from the customer with the assumption that since this is the material that is currently commercially available, it represents the best chemical compound for the application.  The goal of this initial phase is to have a discussion around needs and benefits and not the solution or the feature intended to deliver the result.  In many cases, Shepherd Chemical has been able to demonstrate that a customized or new molecule provides much greater effect in the customer’s system versus an existing commercial material.  In some cases, the customer was not aware of the ability to customize the material according to their needs was focused on the standard material in the marketplace. Once this phase is complete, the Shepherd team brainstorms solutions to the customer’s need and develops chemistries and products which have a high likelihood of achieving the desired result.

 

Once candidate compounds have been developed – a high level economic screen is conducted to insure the proposed chemistries are appropriate for the application from an economics perspective.  The goal of this step is to screen out “over-engineered” products which do not fit the application or market from a cost perspective.

 

Once the economic screen indicates that the proposed product is an economic fit, The Shepherd Chemical Company then undertakes a development program to generate samples of the intended material.  Several samples may be generated depending on the agreed plan for the path forward.  As part of the sample development, a detailed characterization of the material is conducted.  It is Shepherd Chemical’s belief that the right level of effort and detail in this bench phase will yield a significant benefit later in the project when issues such as differences in performance from various runs are observed at the customer.  Detailed characterization of lab samples coupled with their performance at the customer becomes a valuable database for the researchers going forward.  For this reason, Shepherd Chemical has invested in manpower and equipment to perform these detailed characterizations on its custom developed compounds.

 

Shepherd Chemical also conducts a regulatory screen at this stage to assess issues such as TSCA and REACH and presents this information to the customer in order to develop regulatory action plans to support scale up of the best technical candidate product.

 

Following the development of a final laboratory target, a process development engineer works with the laboratory chemist to scale-up the process used at the bench scale. Taking in to account key process variables that affect the final properties, appropriate equipment, future volumes, EHS considerations, and overall process design, the engineer may specify existing equipment or may recommend the installation of new equipment for the process.  Shepherd Chemical’s process development typically allows for quick manufacturing and scale-up in existing assets, however for the sake of long term efficiency and volume, the company also makes recommendations to the customer on future equipment installations that would serve to achieve cost reductions, quality enhancements, or capacity goals.  This conversation is held with the customer at the pilot stage when the chemical manufacturing process is clearer with respect to equipment requirements.

 

Typically several pilot scale runs are carried out and sent to the customer.  Following this stage, economics for the full scale manufacturing process are developed and a formal quote for a commercial run is presented to the customer.  The formal quote allows the customer to gauge the long term pricing for the material.   The structure of the quote will depend on the amount of effort level which is needed to carry out the commercial trials for the customer. Typically a significant effort including engineering, EHS, logistics, packaging, operations, and QC personnel are involved in the design of a first run product campaign or batch.  In many cases, a capital expenditure is involved in the scale-up.  The commercial campaign may be attended by the customer at their option.

 

Following the commercial campaign, the material produced is characterized in detail and compared to the data of prior lab and pilot samples.  In all cases, a set of proposed specifications has been developed at this stage and the analyses results are also compared to ranges.  The material and the analyses are then sent to the customer and their evaluation.  Shepherd Chemical also carries out a post-campaign assessment to understand what went well and what needed improvement in the campaign.  This information is used to optimize future campaigns.

 

From this starting point, Shepherd and the customer continue to optimize both the overall process and supply chain to include packaging, transportation, paperwork and all necessary quality documentation to insure that future deliveries are consistent with the customer’s requirements.

 

 

Using this approach, Shepherd Chemical has successfully launched numerous products and continues to serve the market’s custom manufacturing needs with high quality custom developed organic and inorganic of metal salts and organometallics. This rigorous approach allows both the customer and Shepherd to make the best possible decisions with the information available on both the technical and commercial aspects of the manufacturing program.

 

Please visit www.shepchem.com for more information or contact us.