Production
- Controlled compounding
- Sterile manufacturing areas
- Filling processes
- Packaging and labelling
Manufacturing and Technology
Building a modern pharmaceutical manufacturing platform around quality and control.
Biogenix is developing a manufacturing model in which quality is built into materials, facilities, processes, testing and documentation from the beginning.
Manufacturing Philosophy
Control is intended to begin before production starts.
Biogenix’s manufacturing approach is being designed around controlled processes, appropriate technology, traceability and continuous improvement rather than relying solely on final-product testing.
Facility design, equipment selection, documentation and quality systems are intended to work together as part of the proposed manufacturing model.
Planned IV-Fluid Platform
Automated sterile manufacturing intended for large-volume parenteral products.
The proposed platform is being developed around controlled product preparation, filling, inspection, testing and release. Blow-Fill-Seal technology is being evaluated for the proposed initial manufacturing platform; technology selection and facility capabilities remain subject to technical development.
Manufacturing Process
A planned sequence from controlled inputs to responsible distribution.
The sequence describes the intended high-level manufacturing model. Detailed processes and controls will depend on the product, selected technology and applicable requirements.
- 01
Raw materials and pharmaceutical water
Planned controls begin with qualified inputs and pharmaceutical-water systems appropriate to the process.
- 02
Controlled compounding
Materials are intended to be measured and compounded through documented, controlled processes.
- 03
Container formation and filling
The proposed platform is intended to use an appropriate controlled forming and sterile filling approach.
- 04
Inspection and in-process testing
Planned checks are intended to monitor process performance and product attributes during manufacture.
- 05
Packaging and batch release
Packaging, documentation review and authorized batch-release controls are intended to precede supply.
- 06
Controlled storage and distribution
Storage and distribution controls are intended to maintain traceability and appropriate product conditions.
Supporting Capabilities
Connected systems intended to support controlled manufacturing.
These are planned capability areas and should not be interpreted as completed or operational facilities.
Quality
- Quality Control laboratories
- Microbiology capability
- Quality Assurance systems
- In-process and finished-product testing
Infrastructure
- Pharmaceutical water systems
- Cleanrooms
- HVAC systems
- Engineering and utilities
- Environmental monitoring
Supply and Control
- Raw-material storage
- Packaging-material storage
- Warehousing and traceability
- Controlled distribution
- Waste-management systems
Generic Injectable Manufacturing
The process must be appropriate to each formulation and dosage form.
Each injectable medicine requires an individually appropriate manufacturing and control strategy. Depending on the product, processes may include aseptic processing, sterile filtration, filling and validated sterilization processes.
No single process is assumed to be suitable for every injectable product. Product and technology decisions will remain subject to development evidence and regulatory review.
Science, Technology and R&D
Building knowledge from product selection through continuous improvement.
Biogenix aims to develop or access the scientific and technical capability required for responsible pharmaceutical development and technology transfer.
- Product selection
- Formulation development
- Analytical method development or verification
- Technology transfer
- Process development and scale-up
- Stability studies
- Packaging development
- Process validation
- Continuous improvement
- Automated process control
- Analytical instrumentation
- Controlled documentation
Quality and Partnerships
Manufacturing capability depends on quality systems and capable partners.
Explore the planned quality model or discuss technical, supply and development collaboration with Biogenix.