Agenda1 Case Studies
Summary Agenda1 were selected by the client to assist them with the analysis of their product to develop and validate a method for quantitative metals analysis by ICP-OES in accordance with USP 232 and 233. The client is an international company supplying high quality drug products. In this industry the cost of manufacturing drug products […]
Challenge The client was developing a pMDI drug product with a complex multi-stage manufacturing process involving API re-crystallization and particle size reduction steps . Wide-ranging validated analytical methods (physical, solid-state, chromatographic) were required to release AP I at various stages of the manufacturing process and to support research activities. Agenda 1 was able to deliver […]
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 to the base.
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 catastrophic to the paint supplier. Agenda1 developed a client specific method using in house equipment and an experienced team of analysts to meet the client’s needs and help them improve the specification of their paint The analytical work produced was instrumental in guiding changes to the client’s manufacturing process and helped them develop an improved product.
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.
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, and are now well in into a 2.5 year program. The methods are tested on site with Agenda1 using their wide range of in house equipment, and newly purchased pieces some of which were acquired from the client.
In addition, to support for the method validation work, the client also required additional staff on site, those staff were provided through Recruitment and Temporary staffing division of Agenda1, Agenda1 STaR.
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 faster than available locally to the client.
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 inside a glove box to facilitate low humidity milling.
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, uncomplicated method. Previous techniques had provided Agenda1 with the experience needed to ensure the end result was accurate whilst meeting the client’s requirements.
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.