Services
Capabilities and Strategic Planning
Acertus Pharma is meeting the market opportunities and challenges of Biosimilar. Patents of biotechnology-derived products such as Interferon Alpha, Beta Interferon, Erythropoietin, Human Insulin and Human Growth Hormone have already expired with more expiring over the next few years. In 2012, these global sales were worth over
US$160 billion.
Acertus has a well-trained management team experienced in strategic planning and project execution. This combined with an outstanding, scientific team. Acertus management has in-depth experience and measurable success in the areas of recombinant protein, molecular biology, bacterial and eukaryotic cell fermentation, protein purification and derivatization, formulation, filling and package design. Investors and Business Development enquiries, please email to:
David MashaalAcertus senior management and team of scientist encompass vast experience, hands-on know-how, and a proven track record to develop 1st generation and 2nd generation Biosimilars as well as handle complex management of establishing cGMP manufacturing facilities. This knowledge includes ready to use clones and detailed SOPs for all processes involved in the development and scale-up in addition to the following detailed capabilities:
- Mammalian Cell and Bacterial cell Capabilities
- Assay Development, Qualification, and Validation
- cGMP R&D and Manufacturing Facility
- Process Development from Technology Transfer through cGMP Production
- GMP Lot-Release Testing
- Process Scale-Up Expertise
- Stability Studies
- Cell Culture / Purification Development and Enhancement
- Multiple Scale Research and cGMP Manufacturing
- In-House Regulatory Experience
- CMC Documentation Support
- Dedicated Project Management Team
- Strain development optimisation
- Strain production
- Chemical modification
- Enzymatic modification
- cGMP manufacturing
Acertus key personnel bring hands-on experience in all phases of biotechnology management starting with strategic planning, site planning and construction on to site validation IQ/OQ/PQ:
- Develop, or oversee the development of a Validation Master Plan
- Select special service providers as required
- Develop, or oversee the development of a concise program (capacity projections, type & size of spaces, quantity, people/process flows, utilities, preliminary equipment lists)
- Develop Request for Proposals (RFPs), which integrate all project objectives and requirements, into a seamless package in order to select the premiere consultants and contractors
- Oversee or assist with the oversight of the special services and/or contractors performing the remaining phases of the project ensuring all program requirements are met and all options are explored
- Lead or assist with Factory Acceptance Testing e.g. cGMP Project fundamentals and progress monitoring and reporting including: budget; schedule; change control process; quality control
- Assist in the development and execution oversight of all installation, operation, and process qualification documents and activities
- Ensure that all general and system warranties, spare parts, and preventive maintenance programs are intact and are utilised
