Agenda1 - Case Studies

Focussed Salt Screening Platform for Drug Solubility Enhancement.

Summary Within a two week period, by employing a wide range of in-house equipment and a proprietary method, Agenda 1 isolated and identified  from  a base form of cinnarazine a range of potentially highly soluble salt forms . When tested, all the forms showed improved solubility, with the HCL form showing a 500x increase compared [...]

Supporting the Optimization of a Paint Manufacturing Process

Summary Agenda1 were selected by the client to assist them with the analysis of their product to investigate irregularities found within their paint product. The client is an international company supplying high quality paints to the automotive industry. In this industry  the cost of  manufacturing paint which fails to perform to requirements could be financially [...]

Investigating the Characteristics of Packaging Films

Summary Having previously worked on other projects with them, Agenda1 were selected by the client to assist with two different investigations of issues relating to their high end packaging film products. The investigations used both in house equipment and experienced analysts as well as carefully selected and guided independent suppliers. Background The client is a [...]

On and Off Site Support for Outsourcing Needs

Summary Agenda1 were selected by a major pharmaceutical company, who were under regulatory pressure to reassess over 250 raw material analytical methods. A close affiliation between the client and Agenda1 began to form slowly, with care taken to understand the client’s requirements. Working closely with the client, Agenda1 have written and carried out Validation Protocols, [...]

Working with International Clients-fast turnaround of data

Summary Agenda1 were approached by an overseas client and asked to assist with their development of an amorphous API. Communication routes were established via email and telecom with the project being defined via a series of telecom “meetings”.  Timelines were agreed for shipping of materials and delivery of data which proved to be achievable, and [...]

Supporting Dose Form Development

Summary Agenda1 have a long history of involvement in novel  dose form development and have  extensive knowledge and experience in this area, consequently they regularly  combine a range of techniques to support their clients’ goals.  This example included particle sizing, blending and content uniformity testing, in addition it involved the establishment of  API micronization equipment [...]

Developing and Validating Complex Methods

Summary Agenda1 were selected by a United States based client to transfer and validate a method to quantify the level of crystallinity present in an API starting material and the finished drug product. Using the experience gained from previous similar validation programmes and recognizing the varying levels of validation possible, Agenda1 developed a cost-effective, client-specific, [...]

Specialist Support for the Bone Substitute Industry

Background The bone substitute industry in an industry that has been around for about 25 years in which a man made porous material is created from a material, hydroxyapatite, consisting of two elements. The material is mixed into a paste and then surgeons paste it into the spine or skull and blood vessels are allowed [...]