QBDC GmbH

QBDC GmbH, with locations in Switzerland and Austria, is a biopharmaceutical consultancy firm dedicated to optimizing biomanufacturing processes and providing innovative solutions for the industry. Their core mission revolves around making biopharmaceuticals more affordable and accessible by enhancing efficiency and compliance throughout the drug development lifecycle.

Here's a breakdown of QBDC's key activities and expertise:

1. CMC Development Consulting (Chemistry, Manufacturing, and Controls):

• Regulatory Compliance: QBDC ensures that biopharmaceutical products and processes adhere to stringent regulatory standards (e.g., GMP - Good Manufacturing Practices) set by authorities like the FDA and EMA.

• Process Optimization: They work to streamline and improve manufacturing processes, aiming to reduce costs, enhance product quality, and increase efficiency. This includes everything from DNA to market entry.

• Product Development: QBDC supports clients in developing high-quality, safe, and effective biopharmaceutical products, particularly focusing on biologics such as Biosimilars, ATMPs (Advanced Therapy Medicinal Products), and NBEs (New Biological Entities).

• Scale-up and Tech Transfer: They provide expertise in scaling up manufacturing processes and facilitating technology transfer between different sites or partners.

• QC/QA Support: QBDC offers support in Quality Control and Quality Assurance, critical for ensuring product consistency and safety.

2. Qualification & Validation:

• Document Creation: They assist in creating comprehensive documentation necessary for regulatory compliance.

• Risk-Based Project Management: QBDC employs risk-based approaches to project management, enhancing quality and safety throughout the development process.

• GMP Upgrades: They help companies upgrade their facilities to meet evolving GMP regulations and adapt to changes in product requirements.

• Accuracy and Efficiency: Their focus in this area is on guaranteeing accuracy, efficiency, and regulatory compliance in all qualification and validation activities.

3. Bioprocessing & PAT (Process Analytical Technology):

• Bioprocess Streamlining: QBDC helps clients streamline their bioprocesses to reduce costs and improve overall quality.

• EDDI (Epigenetic Digital Data Interface): A key innovation from QBDC, EDDI is a proprietary digital tool that provides real-time insights into cellular behavior by monitoring gene activation and epigenetic data. This allows for precise cell characterization, eliminates guesswork, and enables informed decisions in bioprocess optimization. EDDI helps in identifying optimal "working conditions" for enhanced cell productivity, revolutionizing biopharmaceutical development by "listening" to cells and translating their signals into actionable digital data.

• Digital Twins: QBDC is working on fusing biochemical pathways and epigenetic data with machine learning (ML) and artificial intelligence (AI) to create digital twins, aiming to further revolutionize the pharmaceutical industry.

4. Digital Tools and Solutions: Beyond consulting, QBDC develops affordable software products to address everyday documentation and data management challenges in biopharma. These include:

• METIS: A solution for managing experimental data.

• Validated Document Management Systems: Affordable and GMP-compliant systems like TEMIS, designed for secure and efficient organization of critical documents and media, particularly valuable for startups, SMEs, and even sections of larger companies. TEMIS focuses on data integrity, audit trails, and multi-user capabilities within a GMP environment.