GxP Consulting is responding to increased demand for expertise across the entire development cycle of biopharmaceutical products and in a number of emerging areas – including stem cell and gene therapy research and the essential vector agents.
These promising yet complex areas of biopharmaceutical research are relatively new to many companies and require specific knowledge in order to maximise their potential for developing new treatments. As part of this, there is a need to establish the regulatory compliance requirements of these new products as early as possible and integrate these within the overall development, approval and manufacturing process as efficiently and effectively as possible. The GxP Consulting biopharmaceutical process team can assist companies looking to make further advancements in these new areas of research by offering a full range of experience-based 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 existing and new customers. In response to the global economic downturn, GxP Consulting is now 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.
Mark Stevens, managing director at GxP Consulting, said: “It is a very exciting time in the biopharmaceutical industry with new streams of research and clinical studies that are introducing innovative new products and technologies. However, as advances are made, businesses seek the necessary expertise to ensure that projects run efficiently and reliably at every stage of the process. The GxP Consulting biopharmaceutical process team can offer the most appropriate advice to ensure each project is a success and that companies have available all the help and experience they need for their current and future development plans.”
The comprehensive 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 extensive 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 the Flu treatments and the development of products using novel technologies such as stem cell and gene therapy. The team can offer experience-based 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 even 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. Utilizing the latest IT tools and an extensive library of configurable templates enables the GxP Consulting team to get projects up and running in the fastest time possible.
The experienced GxP Consulting team is led by Dr Steve Collins and supported by principal consultant, Keith Williams. Steve has more than 30 years’ experience in the biotechnology and pharmaceutical sectors, including work with recombinant proteins, monoclonal antibodies, bacterial products, vaccines, cell culture therapies and radiochemicals. Keith has been working in the biopharmaceutical industry since 1989 and has been involved with production management, engineering design, project management, commissioning, validation, strategic planning and high-level consultancy.
GxP Consulting provides high-value, results-focused regulatory compliance services to the highly regulated pharmaceutical and biopharmaceutical industries. The company has expanded in order to support its growing number of clients globally with the continual increasing requirements of regulatory compliance, covering pre-clinical (GLP), clinical (GCP), manufacturing (GMP) and wholesale storage & distribution - Good Distribution Practice (GDP) business areas.
GxP Consulting (gxpeu.com) provides businesses with high quality, results-focused regulatory compliance (GMP, GAMP, GLP, GEP, GCP, GxP), qualified person (QP), quality assurance (QA), consulting, project management, validation, process engineering, computer systems, laboratory equipment, project management, design studies, training and clinical technology consulting services. Specializing within the Biotechnology, Pharmaceutical, Consumer Healthcare, Medical Devices and Veterinary industries, GxP Consulting provides a range of services to meet customer’s needs.