Process Development

The development of a process to make a new chemical entity is not a simple procedure and a project leader will need to be appointed, if one has not been there during the speculative research phase. Process development usually costs several times more than the expenditure on the initial product research and is not entered into lightly. The procedure adopted for process development needs thoughtful planning, if time and money are not to be wasted. The procedure, which is described here, is normally applied to novel chemical entities, but many of the aspects apply equally to the addition of a known material to a company's selling range.

Optimisation of the materials usage, yield, time and other parameters of the laboratory method, used by the research chemist to make the original speculative sample, will not have been carried out at this stage in the project. Additionally the process, even if a good one for the laboratory, will not necessarily be one which will work or fit into an existing manufacturing plant. The first task of the project leader along with the development chemist or Manager is to ask a series of questions on the characteristics of the process that has so far been used to make the new product.

• Chemical unit processes. Are they ones that are currently operated on the plant or are there good analogies? For example, if it involves the current nitration, reduction, chlorination and enzymatic catalytic oxidation processes operated in the company, the available chemical experience will be satisfactory for the development. If, however, it involves highly reactive organometallic reagents, beyond the current expertise of the company, new learning will be required or experience brought into the team from elsewhere or that stage outsourced to another group or company.

• Unit operations. Are the unit operations ones that are currently used, e.g. distillation, fermentation and freeze-drying? Ifit is new to the plant, is the necessary chemical engineering expertise to implement the operation available?

• Plant requirements. Is it a single stage, multi stage batch, continuous process or any combination of these? Will it use the existing plant or is a new plant required? If it is the latter, chemical engineers and a design team will be involved.

• Manufacture. Will the first manufacture be on a commercial scale or will there be a need for pilot plant quantities of material.

The answers to the above questions will enable the project leader, in collaboration with the relevant Managers, to assign the correct personnel to the project at the start of the development work and to plan for additions later on as required.

The performance criteria on product quality for the development candidate may have changed marginally since the production of the original target document. Even if they have not changed, it is good to reiterate the performance criteria so that they are fully understood by all the new parties who are involved. The details in any statement of profitability criteria, especially the desired manufacturing cost, will have become firmer by this stage and agreed with the business function. An early indication of whether capital will be available for any new plant or plant items is also necessary, as its availability will materially affect the decisions made during the process development phase.

Project Management Made Easy

Project Management Made Easy

What you need to know about… Project Management Made Easy! Project management consists of more than just a large building project and can encompass small projects as well. No matter what the size of your project, you need to have some sort of project management. How you manage your project has everything to do with its outcome.

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