Pre-clinical Manufacturing
Generally, drug development is a time-consuming and expensive process including pre-clinical, clinical and after-market development, in which procedures are strictly evaluated to ensure the effectiveness of the drug. Pre-clinical trails, also known as pre-clinical studies, is a research stage prior to the clinical trials. Pre-clinical production of drugs mainly consist of experimental studies of biological drugs, small quantities of reagents and intermediate reagents. BOC Sciences has the comprehensive infrastructure, quality systems and professional personnel to get your product through the clinic and into commercial manufacturing. Our expert teams are committed to providing a complete, seamless development through manufacturing solution.
Figure 1. Typical Drug Development Process: Quality by Design. (Neadle, S.; Vàradi, I. 2018)
Our Services
To make it easier and better for researchers, BOC Sciences provides pre-clinical manufacturing service in a competitive fashion. We have provided a more efficient way to increase the number of new drugs, greatly shorten the R&D cycle, and reduce the development costs. The goal of BOC Sciences' pre-clinical manufacturing team is to get your drug product into the clinic. Our pre-clinical drug product manufacturing services include R&D, engineering and GLP pilot product manufacturing, as well as full analytical services for sterile and non-sterile products
- We support a variety of advanced technologies, including emulsions, gels, nanoparticles, drug-device combination products, solid solutions
- We can produce and characterize a variety of dosage form for any route of administration, making your material suitable for in vitro and in vivo testing
- BOC Sciences starts with the pre-clinical phase of the program by developing a series of formulation prototypes that are evaluated against in vivo and in vitro models to effectively define a lead drug product formulation
- We are able to scale up for manufacturing of GLP test products with appropriate quality assurance (QA) oversight to ensure all regulatory requirements are met
- Seamless pathways for complex formulations: Our teams have the equipment, engineering and facility flexibility to design and produce developmental materials for the most complex formulations, including sterile products, emulsions and implants
- Analytical and engineering capabilities: Our analytical services begin with early-stage method development that progresses in parallel with formulation development. Our in-house engineering team then develops scalable processes to ensure reliable clinical production
Figure 2. Typical Drug Development Clinical Studies. (Neadle, S.; Vàradi, I. 2018)
Why choose BOC Sciences?
Our dedicated CMC team has provided tailored solutions to our clients from engagement to launch. With many years of industry experience, we provide clients with the following:
- Comprehensive, integrated CMC services with a flexible service model that grows with your programs
- Knowledgeable industry experts who deliver scalable, actionable insights
- World-class facilities and equipment that remain at the forefront of the global pharmaceutical research, analytical and development standards
- Our comprehensive services support products at every stage of the product lifecycle, from early-stage discovery to full commercial cGMP manufacture
- A focus on risk management that is designed to ensure completion of your technical goals
BOC Sciences provides professional, rapid and high-quality services of pre-clinical manufacturing at competitive prices for global customers. Personalized and customized services of pre-clinical manufacturing can satisfy any innovative scientific study demands. Our clients have direct access to our staff and prompt feedback to their inquiries. If you are interested in our services, please contact us immediately!
Reference
- Neadle, S.; Vàradi, I. Product development and manufacturing challenges for combination products. American Pharmaceutical Review. 2018. 21(1).
