OncoGenerix sets the NEW STANDARD in injectable process development and manufacturing services.
OncoGenerix offers a fully integrated suite of contract manufacturing services including technical transfer, process development, scale-up, equipment and process validation, formulation, filling, lyophilization, inspection, labeling and packaging, meeting the requirements of the US FDA, EMA, CFDA and PMDA.
The values of OncoGenerix focus on OPERATOR SAFETY, ENVIRONMENTAL SAFETY, QUALITY and COMPLIANCE. OncoGenerix utilizes ADVANCED ASEPTIC MANUFACTURING TECHNOLOGY and proven methods to provide cost-effective manufacturing services.
OncoGenerix operates within a highly defined, risk-based QUALITY MANAGEMENT SYSTEM reflecting the most up-to-date regulatory guidelines for the management of the product life cycle.
Advantages of OncoGenerix
- Flexibility and Scalability:
- OncoGenerix’s manufacturing process is fully scalable, allowing clinical production and commercial production in the same process. We can accommodate a batch range from 1 to 1,000 liters, with a vial range of 2mL to 100mL.
- Communication and Customer Focus:
- To ensure compliance, all site documents are in Chinese and English with English being the primary language of the site.
- OncoGenerix provides an empowered dedicated project manager to coordinate all activities on behalf of the client on site. Our services are focused on individual client’s requirements and goals.
- Commitment to Safety and the Environment:
- Comprehensive site environmental, health and safety systems.
- Integrated liquid waste management and treatment system allows site-based treatment and neutralization or removal using certified waste management contractors.
- Defined biohazard and solid waste managements systems using certified waste management contractors.
- Fully Integrated Process Development, Validation and Commercialization Services:
- Detailed evaluation of innovator product development status and preparation of strategy for process development, process validation, stability, regulatory filing and commercialization.
- Preparation of efficient and effective technical transfer and scale up plans from product clinical development through commercial manufacturing, considering the total product life cycle.
- Product process development and validation, including analytical methods, formulation, product fluid path (single use and dedicated), lyophilization cycle, container closure integrity, product inspection, product packaging and cleaning.
- State of the Art Manufacturing Capabilities:
- Using ISO 5 isolator based advanced aseptic manufacturing technology located in an ISO 7 cleanroom environment, ensuring high levels of sterility and containment.
- Meeting US FDA, EMA, CFDA & PMDA regulatory requirements for clinical and commercial supplies.
- Using a QbD risk-based approach (FDA Process Validation 2011, ICH Q8, ICH Q9, ICH q10, GAMP, ISPE Commissioning Qualification Baseline, 21 CFR 211 and EU GMP regulations) within a Defined Life Cycle (ASTM E2500) for implementation, qualification validation of process and facilities. This approach uses the highest quality and compliance standards resulting in products that fully meet the clinical needs of the patient.
- Cost Effectiveness:
- OncoGenerix drives cost effectiveness through the quality management system where continuous evaluation and improvement is used to ensure a high level of equipment and process reliability and availability.
- OncoGenerix’s engineering and maintenance teams have subject matter experts for the facility control systems, and each item of process equipment. This allows diagnostic and repair of issues in-house without the need for external vendor support.
- OncoGenerix uses a high level of automation, minimizing the potential of operator intervention errors.
- OncoGenerix uses waste heat and water recovery systems to minimize utility consumption.
- Open Information Sharing (Open Source):
- As a part of our commitment to our clients, OncoGenerix provides the client total access to their specific product and process technology information including procedures, protocols and data gained through realization of the product manufacturing process.
- We also provide our clients with client office facilities for on-site monitoring of the manufacturing process.
- World Class Engineering Services:
- OncoGenerix has a world-class engineering team with the capability to develop, implement and qualify custom manufacturing technology from a single item of equipment to an entire facility.
- The OncoGenerix engineering team provides the client with the ability to test a manufacturing technology off-line from their facility and transfer the technology to their facility once established.
- The OncoGenerix site team is self-sufficient and has all the necessary skills to undertake equipment design, testing (including test method development, note book studies and engineering studies) qualification, maintenance and repair, eliminating reliance on outside equipment vendors.
With 25+ years in the pharmaceutical industry, Alexander has extensive operations management of the projecting, production and regulatory activities, facility operation. Alexander specializes in management of final formulations pharmaceutical facilities including sterile filling of highly toxic compounds, management of aseptic manufacturing processes validation of liquid final dosage forms of cytostatic, management of API pharmaceutical facilities including fermentative processes, highly potent and highly toxic synthetic and semi-synthetic processes, management of new projects in pharma industry, preparation of concept projects for new facilities, preparation of basic engineering of projects, management of development of new manufacturing processes for new APIs. Alexander is also the author of more than 15 patents and patent applications in chemistry and pharmacy of anticancer compounds.
Ramana Reddy Muchumari
Director of Quality & RA
With 13+ years in the pharmaceutical industry, Ramana skilled in Quality and regulatory affairs management, corporate & site quality operations, people management, handling of collaborative projects, trainings and dealing with multicultural and multi-national assignments.Ramana specializes in establishing Quality Management Systems in green and brown field projects, cGMP training, product technical transfer, supplier management programs, strategic planning, regulatory audit management, regulatory audit responses, post-inspection remediation, cultural change, data integrity process, mapping and people development. Ramana has extensive experience in dealing with regulatory agencies including, USFDA, MHRA, COFEPRIS, German Authority, PMDA, KFDA, WHO and local state / province regulatory agencies.Ramana holds a masters degree in chemistry, and Doctorate in Management Studies (DMS)-specialization in Total Quality Management.