SOLVING COMPLEX PROBLEMS
IN BIOLOGICS DRUG
OUR KEY SOLUTIONS
NAVIGATING COMPLEX ISSUES IN BIOPHARMACEUTICALS DEVELOPMENT
1. IMPROVE
The Innovator Benchmark is a High Bar. Your drug's success hinges on meeting it. We provide the expertise to modulate these key quality attributes of your product in upstream processing. By precisely matching these attributes to the market's leading drugs, we help you overcome regulatory hurdles and stand out in a competitive landscape.
BIOSIMILARS OPTIMIZER
Success of Biosimilar’s Sustainable Competitive advantage defines by three key pillars;
- Bio-Yield
- Highly Similar Critical Quality Attributes
- Timely Regulatory Approvals
- Expert in Improving Bio yields to improve bottom line.
- Specialize in optimizing your critical quality attributes (CQAs) of your products, including but not limited, glycans, charge variants, oxidation, aggregates, low molecular weight species, and sequence variants which turns Faster CMC regulatory approvals.
ADVANCING IN VIRAL VACCINE MANUFACTURING
Expert in Improving Bio yields to improve bottom line.
Key Area of Expertise
Micro-Carrier Technology
Semi-Perfusion for multiple harvesting
Serum free Culture
2. IDENTIFY
Uncover GMP and CMC gaps & Secure your Regulatory Success
Your path to market success is our priority. We provide targeted GMP Gap Identification, comprehensive CMC Gap Assessments, and rigorous Technology Due-Diligence. Our expertise ensures your projects are de-risked, compliant, and ready for the future. We deliver the clarity you need to move forward with confidence.
Comprehensive GMP & CMC Gap Assessments:
Holistic GMP Review
In-depth analysis of your Good Manufacturing Practices against current regulations and industry best practices.
Critical CMC Evaluation
Thorough assessment of your Chemistry, Manufacturing, and Control documentation and processes for regulatory alignment.
Data Integrity Focus
Ensuring the reliability and trustworthiness of your critical quality data.
Supply Chain Security
Identifying potential vulnerabilities and gaps within your raw material and finished product supply chain.
Strategic Technology Due Diligence:
De-risking Technology Adoption
Comprehensive evaluation of new technologies for feasibility, scalability, and regulatory implications.
Informed Investment Decisions
Providing objective insights to support strategic technology investments.
Intellectual Property Review
Assessing the strength and potential risks associated with the technology's IP landscape.
Operational Integration Analysis
Evaluating the seamless integration of new technologies into your existing workflows and systems.
3. Next-generation Bioproduction
BIOMANUFACTURING SOLUTION
- Upstream Solutions
- Downstream Solutions
- Integrated Bioprocess Solution
