Development services for early stage products

One of the greatest challenges in the pharmaceutical industry today is to closely match a product’s active substance with its mode of administration. Excellence in the design of application systems and corresponding production processes is crucial to guarantee efficiency in commercial production. Special care has to be employed when handling sensitive substances. Furthermore, if a drug is to be successful, competitive application systems must be developed early.

Vetter Pharma is a leading international specialist in the manufacture of aseptically pre-filled application systems. For over 25 years, Vetter Development Services (VDS) has been assisting pharmaceutical and biotech companies develop new liquid or freeze-dried application systems quickly, efficiently and with the utmost care, thus reducing time-to-market. As an independent company without its own products, Vetter can guarantee its customers absolute loyalty and confidentiality.

Vetter’s commitment to its customers begins in the initial phase of drug dosage development. The VDS laboratory has the specialists and top of the line equipment necessary to design state of the art processes for parenteral administration of the drug. The process starts with the selection or development of an application system which is then customised for the respective active substance.

Biologics often involve highly sensitive active substances. For example, they might be incompatible with an application system or a component. Sensitivity to light and precipitation coming in contact with silicon are other challenges in dosage form development. This is where Vetter’s extensive experience with the filling of aseptic drugs can be brought to bear. Vetter offers the value added by its own innovative injection systems, such as the Vetter Lyo-Ject â dual chamber syringe, and other tested components. Official approval is already prioritised during the development stage. With more than 15 products already in the market, Vetter is well versed in the latest FDA requirements. More than 125 patents, including protection against imitations and counterfeiting, are evidence of competence, application safety and patient-friendliness.

Prior to clinical production, the production process is defined and technically optimised. The best processes for liquids or lyophilised products are determined and continuously scrutinised in feasibility studies as well as engineering batches, stability batches, clinical batches and regular validation batches. Packaging materials are analysed for their quality to guarantee readiness for market production.

During the final clinical stage, Vetter establishes a solid manufacturing process for the product. VDS then transfers the products directly to Vetter Commercial Manufacturing (VCM). VDS staff members carefully monitor the validation batches in order to achieve a smooth transfer to production. Still, all the requirements for commercial manufacturing are taken into consideration during process development. Changes in the parameters might still become necessary. An existing lyocycle process may need to be optimised in an already established production process; or life-cycle management might be carried out on a product. For example, a liquid formula may be developed for a freeze-dried product. In such cases, the product can easily be transferred again to VDS for further development.

During development, Vetter also compiles the necessary documents for international regulatory approvals. Every development and production step performed at Vetter is integrated and reflected in the documentation. Experts with comprehensive knowledge of the Vetter systems, as well as FDA and EMEA requirements write all the technical documents. Vetter’s customers receive the complete chemistry manufacturing and controls part of the drug product section. These documents are drafted to meet applicable requirements, and can be fully included in the documents to be submitted for regulatory approval.

Vetter has extensive global experience and expertise in the official approval process that is made available to its customers. Vetter has worked with the US FDA and EMEA as well as regulatory authorities throughout the world, including Canadian, Russian, Brazilian, Saudi Arabian and Mexican authorities, not to mention, domestic German regulatory authorities, all of which have inspected Vetter.

< Back to Manufacturing index

< Back to Process Engineering index

< Back to Market Resources index