Non-GMP Manufacturing
In addition to producing APIs according to GMP (Good Manufacturing Practice) standards and requirements, we also provide process development and analytical services for non-GMP/GLP grade APIs during the preclinical development phase. These non-GMP manufacturing services are available for a wide range of customers, including universities, research institutions, biotech companies, pharmaceutical companies, and more. Moreover, BOC Sciences can accommodate different research scales and also provide additional analytical and storage services.
Figure 1. API supplier change or addition causes. (Mallu, U. R. 2015)
Our Services
To make it easier and better for researchers, BOC Sciences provides non-GMP 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.
- For early stage projects under time and quality pressure, our teams have adopted a risk-based, non-GMP approach that includes a road map for increasing GMP over time
- The flexibility of the non-GMP solution is included, taking into account the immediate needs of the customer as well as the long-term business requirements
- Our cross-functional teams from process development, quality and regulatory affairs have extensive experience in successfully introducing chemical steps from non-GMP to GMP scale to drive commercialization of small molecule APIs or drug products with full regulatory compliance
- Rapid development of scalable and robust chemical processes using advanced process methodologies in the fully-equipped kilo-lab provides a quick supply in the early development phase
- Maximum flexibility and better budget control for early phase projects: We clearly understand the phase appropriate regulatory requirements, and we have abilities in back integrationof large scale hard-to-find raw material non-GMP production
Figure 2. GDP life cycle with API supplier selection, change or addition. (Mallu, U. R. 2015)
State-of-the-art equipments
Our non-GMP development services provide you with greater flexibility and speed. With our state-of-the-art facilities, we are able to focus on lab-scale experiments with batch sizes ranging from<1 kg to approximately 5 kg for most technologies. Since our non-GMP and GMP facilities are co-located, we can provide a seamless transition between the development and GMP phases for projects in the early stages of development.
- 20L, 50L, 100L and 200L jacketed glass reactors with a temperature support ranging from: -70°C to 200 °C
- Agitator types (Anchor, Retreat, PBT, Flat blade, Rushton disc)
- Laboratory distillation set up: Regular and Packed columns
- High pressure reactors upto 75 kg pressure
- Freeze driers
- HPLCs for in-process monitoring
- KF titrator
Our features
By intentionally ensuring that all technologies are well integrated in both non-GMP and GMP facilities, we can efficiently perform non-GMP work and then quickly move to GMP production. In essence, our seamless process accelerates your entire project-to-clinical timeline and eliminates risk to your clinical manufacturing activities.
- Producing output from grams to lower kilograms per batch
- Equipment of different capacities operating over a wide range of temperatures
- Cryogenic reactions down to -35°C at different scales
- Hydrogenation reactions
- For downstream processing, we have different equipment for filtration and drying.
- Combiflash systems and glass columns are available for carrying out chromatographic separation
- HPLC & SFC purification and separation is performed using a variety of systems in normal as well as in the reverse phase
Figure 3. Change or addition of alternative API supplier in review phase. (Mallu, U. R. 2015)
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 non-GMP manufacturing at competitive prices for global customers. Personalized and customized services of non-GMP 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
- Mallu, U. R. API Supplier Change or Addition of Alterate API Supplier in Generic Drug Products: Cost, Quality and Regulatory Factors. Pharmaceutica Analytica Acta. 2015. 6(5): 1000364.
