BAG Health Care GmbH – A Reliable CDMO Partner for Parenteral Drug Products

BAG Health Care GmbH is a GMP-certified Contract Development and Manufacturing Organization (CDMO) based in Lich, Germany, offering comprehensive fill & finish, lyophilization, and analytical services for sterile parenteral drug products. With a proven track record in both clinical and commercial manufacturing, BAG Health Care combines regulatory expertise, state-of-the-art infrastructure, and client focussed project management to serve pharmaceutical, biotech, and life science companies worldwide.

GMP-Compliant Aseptic Filling

BAG Health Care specializes in aseptic fill and finish of sterile drug products into vials ranging from 2R to 50H, using two fully automated, Annex 1-compliant filling lines from Bausch + Ströbel and Rota. With a capacity of up to 6,000 vials per hour, these lines support both small-scale clinical trials and commercial batch production, handling volumes from 1.2 L to 200 L. Optimized for low dead volumes (<500 mL), BAG is an ideal partner for high-value biologics or early-phase candidates.

Industrial-Scale Lyophilization

BAG operates three GMP-qualified freeze dryers (4 m², 8m² and 17 m²), capable of producing up to 70,000 vials per batch. The company supports development-to-scale lyophilization for biologics, peptides, and solvent-based formulations. With hands-on collaboration between formulation experts and process engineers, BAG ensures a seamless transition from lyo-cycle development to validated commercial production.

In-House Analytical Services

BAG’s analytical labs offer full GMP-compliant testing throughout the product lifecycle:

Additional specialized testing (e.g., sterility, endotoxins, LC/MS) is performed through qualified partner labs. Whether for method transfer, or release testing, BAG delivers reliable, auditable data to support regulatory filings and product safety.

GMP Packaging and Storage Solutions

BAG provides secondary packaging for both clinical trial supply and market-ready commercial batches, including EU-compliant serialization in line with Directive 2011/62/EU. GMP warehousing includes temperature-controlled storage zones:

This integrated model ensures full cold chain integrity and supply chain compliance from manufacturing to final shipment.

Regulatory Support & Qualified Person (QP) Release

Every batch at BAG is subject to 100% visual inspection, container closure integrity testing (CCIT), and QP certification. BAG’s QPs manage batch release, prepare CoAs and CoCs, and assist with process validation and audit preparation – ensuring your product is always regulatory-ready.

Efficient Tech Transfer and Project Management

Technology transfer at BAG is structured, risk-based, and tailored to your organization’s needs. Each project includes:

• Gap analyses

• Timeline and communication planning

• Validation strategy

• Deviation and documentation control

• Full project ownership or collaborative execution models

Your dedicated project manager ensures alignment with clinical timelines and regulatory milestones – from kickoff to commercial launch.

Why Partner with BAG Health Care?

• GMP, ISO 13485, Annex 1 compliant facility

• Clinical to commercial scalability

• Expertise in lyophilized and liquid formulations

• European serialization and supply chain services

• Responsive, science-driven project execution

• Strong regulatory track record (IMPD, EMA, FDA-relevant quality)

Whether you’re a biotech developing a niche therapy or a global pharma looking to establish an EU fill & finish partner, BAG Health Care provides technical depth, regulatory confidence, and operational reliability.