GXP Consulting has announced the launch of its expanding biopharmaceutical process support services in response to demands for expertise across the entire product development cycle.
The company's biopharmaceutical process team can assist companies looking to make further advancements in new areas of research by offering a range of support at each stage of the process, from early development and regulatory application to analytical method development, scale-up, facility design, technology transfer, marketing authorisation and full-scale commercial manufacture.
GXP Consulting has also announced the introduction of a range of smart services targeted at providing maximum value to customers.
In response to the global economic downturn, GXP Consulting is offering a suite of added-value options to help its clients fulfil their regulatory compliance responsibilities: complimentary initial consulting sessions, pre-payment incentive schemes and training packages that include consulting sessions at no extra cost.
The biopharmaceutical process service incorporates initial evaluation and feasibility studies to ensure the most appropriate strategy is chosen in order to minimise time to market and also provides support at each product lifecycle phase through to post-licensing projects.
Expertise within the GXP Consulting team includes mammalian cell and microbial fermentation, egg/vaccine systems currently in use for flu treatments and the development of products using novel technologies such as stem cell and gene therapy.
The team can offer advice and leadership on topics such as: clinical trial strategy; regulatory approval strategy; process and quality requirements for sterile, parenteral products; protein purification; down-stream processing; process trouble-shooting; biosimilar process development; analytical assay development; validation master planning, and the building and training of entire new teams.
Tactical support is available including: clinical study project management; e-clinical technology selection, implementation and integration; facility design services, including equipment and utilities; project cost estimation for design, build and validation activities; product safety; process validation; cleaning validation; comparability studies and stability studies.
Support is also provided on all process related documentation, such as SOPs and batch manufacturing records (BMR).
GXP Consulting can provide interim management support and help companies to develop knowledge transfer and training strategies in order to ensure projects and operations run efficiently.
Utilising the latest IT tools and a library of configurable templates enables the GXP Consulting team to get projects up and running quickly.
