BAG Health Care will be joining Innovatrix as Silver Sponsors of our upcoming event, the 6th Aseptic BioPharma Processing Summit, taking place on September 22-23, 2026, in Vienna, Austria.
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BAG Health Care GmbH is a company located in Amtsgerichtsstr. 1-5, Lich, Lich Hess, Germany. They develop, produce and sell in vitro diagnostic agents and products for hygiene monitoring in the newest state of the art. As a pharmaceutical contract manufacturer, they specialise in the production of parenterals and lyophilisates.
Aseptic Filling
Precision, Compliance, and Flexibility for Vial-Based Drug Products
At BAG Health Care, aseptic filling is our core expertise. We provide GMP-compliant fill and finish of sterile parenteral drugs in vials from 2R to 50H—ideal for clinical and commercial production.
Our Annex 1-compliant filling line (Bausch + Ströbel) and small-scale Rota filler support volumes from 1.2 L to 200 L, with filling speeds up to 6,000 vials/hour using precision piston pumps. We handle dead volumes under 500 mL, maximizing yield for early-phase and high-value biologics.
We manage the full process—from tech transfer to validation. Dedicated project managers ensure clear communication and regulatory-compliant protocols for IMPD or MAA filings.
Lyophilization
Scalable Freeze Drying with Industrial Expertise
We offer GMP-qualified lyophilization for biologics, peptides, and sensitive actives. With three freeze dryers (4, 8, and 17 m²), we support batch sizes from 500 to 70,000 units (2R), covering early-phase to commercial production.
Our equipment handles complex formulations, including those with organic solvents. We collaborate with your team to industrialize and optimize the freeze-drying process from development to GMP scale-up.
Analytical Services
Science You Can Trust, Results You Can Act On
Our in-house labs support the full lifecycle of parenteral drug products, from raw material testing to release and stability studies.
Capabilities include:
- HPLC (UV/VIS, DAD)
- Karl Fischer titration
- FT-IR spectroscopy
- Polarimetry, refractometry, viscosity testing
- Elemental impurity control
- USP/Ph. Eur. methods
- ICH stability studies
For specialized testing (e.g. LC/MS), we work with audited partners. We offer method development, transfer, and identity verification to ensure product safety, stability, and compliance.
Secondary Packaging & GMP Storage
Safe, Secure, and Ready for Shipment
After production, we handle secondary packaging and GMP-compliant storage to simplify your logistics and ensure supply chain integrity.
We provide labeling, boxing, and carton packaging for clinical and small commercial batches, including EU serialization (2011/62/EU).
Storage options include:
- –80 °C for drug substances
- –20 °C and 2–8 °C for drug products
- 15 – 25 °C ambient storage
Integrated packaging and storage ensure your product remains safe and compliant from fill to final delivery.
Regulatory Compliance & QP Release
Confidence Through Quality
Regulatory compliance is our foundation. We hold full GMP approval for clinical and commercial manufacturing, including Annex 1 adherence and QP services.
Each GMP batch undergoes 100% visual inspection and container closure integrity testing (CCIT). Our QPs manage batch release and issue CoAs or CoCs.
We support:
- Human and veterinary drugs
- Medical devices
- Raw materials for ATMPs
We handle validation, CQA/CPP assessments, and documentation—keeping you audit-ready.
Technology Transfer & Project Management
From Kickoff to Commercial Launch
We ensure smooth technology transfer with a structured, collaborative approach tailored to your needs.
Our process includes:
- Gap analysis
- Transparent timelines
- Risk-based assessments
- Clear roles and communication
Choose your level of involvement—from joint collaboration to full-service management, including deviation handling, validation coordination, and submission support. We don’t just fill vials—we bridge gaps with expertise and reliability.
To connect with BAG Health Care and work with them to find the perfect solution for your aseptic processing needs, contact them here.
To join BAG Health Care and other solution providers, discuss aseptic processing and the key issues facing the industry, and network with delegates, attend the 6th Aseptic BioPharma Processing Summit taking place on September 22-23, 2026, in Vienna, Austria.
For more information, visit our website or email us at info@innovatrix.eu for the event agenda. Visit our LinkedIn to stay up to date on our latest speaker announcements and event news.
