Ensure Successful Approval of Biologics with a Cutting-Edge Solution
Achieving the green light for biologics is a challenging feat. It’s all about having the perfect dance of data that unveils your biotherapeutic’s intricate details and structure, showcasing its safety, efficacy, purity, quality, and strength.
Why does this matter? Well, it plays nicely with the FDA and EMA/MHRA guidelines. It is your trusted guide through the rollercoaster of drug development – from choosing your star candidate to the grand finale of commercial-scale manufacturing.
Now, here’s where the plot thickens. Green Biotec is your superhero, armed with a complete biological characterization solution. Picture purpose-built instrument platforms, off-the-shelf assays, and custom assays riding in on a white horse to meet the challenges posed by those complex biological therapeutics.
The Green Biotec Solution: Navigating the Biologic Seas
Biosafety Testing:
Say goodbye to contaminants! Our comprehensive portfolio of test methods ensures your biopharmaceutical products are as pure as a mountain stream. Dive into the world of biosafety testing with us.
Protein Characterization:
Plot twist: Successful IND submission and market authorization rely on robust protein characterization. From binding assays to biophysical characterization, we’re the sidekick you need for every stage of development.
But wait, there’s more:
- Microbiological Contaminants
- Species Specific Viruses
- Genetic Stability Testing
- And a bunch of other superhero-like assays under our belt!
1. Microbiological Contaminants: The Vigilant Protectors
Imagine them as the shield against unseen invaders. Our microbiological contaminant assays stand guard, ensuring your biologics remain pristine and free from microbial foes.
2. Species-Specific Viruses: The Guardians of Specificity
These essays are like superheroes with a sixth sense. They specifically target viruses, ensuring your biopharmaceuticals remain untouched by species-specific viral threats.
3. Genetic Stability Testing: The Sentinels of Consistency
In the world of biologics, consistency is critical. Our genetic stability testing assays act as sentinels, ensuring the genetic makeup of your biopharmaceuticals remains unwavering, steadfast, and ready for action.
4. And Many More Superhero-Like Assays!
Beyond these formidable trio, our repertoire includes a host of other superhero-like assays, each with a unique power to ensure your biopharmaceutical products’ safety, efficacy, and quality. From binding assays to biophysical characterization, we’ve got the entire superhero squad under our belt!
An Experienced Partner in Product Characterization
Shorten Your Analytical Development Timelines:
Why waste time developing assays when you can leapfrog with our validated analytical and safety assays? Customize them to your liking, and your development timeline just got a nitro boost.
Access Insights and Expertise When You Need It:
Consider us your on-call analytical wizards. When you’re in a tight spot, we’re here with insights and expertise, ready to wave our magic wand and simplify the complex.
Count on Integrated Quality:
Quality is our middle name. We bring it into the equation seamlessly, ensuring your journey is successful and top-notch.
Related Assets: Dive Deeper into the Biologic Universe
- Orthogonal Chromatographic Techniques for Therapeutic Protein Characte. Read the Blog Article
- Characterization of Protein Structure: The Value of Intact Mass Analyses. Read the Blog Article
- Why Glycan Analysis is an Essential Part of Therapeutic Protein Charac. Read the Blog Article
Explore More Related Content
Your biological journey doesn’t end here – a wealth of knowledge is waiting to be unraveled. Embark on a quest for more profound insights with these captivating chapters:
- Cell Line Development: Have you ever wondered how those remarkable cell lines come into existence? Unveil the mysteries of cell line development and the genesis of your biotechnological superheroes. Learn More
- Cell Banking: Your cells are precious treasures, and their safety is non-negotiable. Delve into the intricacies of Cell Banking, where assurance meets security, ensuring the longevity and vitality of your biological assets. Learn More
- Lot Release Testing: The journey doesn’t end with development – it extends to quality assurance. Explore Lot Release Testing, the ultimate checkpoint ensuring your biotechnological products meet the highest standards. Learn More