BAG Health Care

BAG Health Care

Parenteral F&F provider for vials in small to mid sized batches.

About the plant

Corporate Profile – BAG Health Care GmbH

BAG Health Care GmbH is a privately held, family-owned CDMO located in Lich, Germany, with over five decades of experience in aseptic fill & finish of parenteral drug products. Renowned for its precision, compliance, and client-focused approach, BAG is a trusted manufacturing partner for pharmaceutical and biotech companies worldwide—including those developing biosimilars and other sensitive biologics.

BAG specializes in the aseptic filling of vials ranging from 2R to 50H and offers a robust track record in handling biologics, peptides, nucleotides, and small molecules. The company also supports adjacent areas such as sterile solutions regulated as medical device components and raw materials for ATMP production. This breadth of experience, coupled with technical depth, ensures reliable support across a wide spectrum of formulation types and regulatory requirements.

As an end-to-end service provider, BAG offers comprehensive support from technology transfer and process development through aseptic filling, lyophilization, and secondary packaging. In-house analytical services, QP release, ICH-compliant storage, and stability programs round out a full-service package designed for clinical and commercial needs. The manufacturing infrastructure is fully GMP-certified and Annex 1 compliant, with a proven track record in terminal sterilization and aseptic processing. More than 80 % of our batches are released for commercial supply—highlighting BAG’s maturity in managing market-ready products.

With a particular focus on small to mid-sized batch production, BAG is ideally positioned for biologics companies seeking flexible, responsive, and high-quality fill & finish solutions. The company’s ability to scale efficiently, meet complex handling requirements, and maintain high compliance standards makes it an optimal partner for early-phase through commercial launches—especially for products that require careful process control and a high degree of aseptic assurance.

At BAG Health Care, we empower our customers’ success through scientifically grounded precision, empathetic collaboration, and passionate dedication. Our collaborative spirit drives our core promise—to lead our clients to success. Whether for pilot-scale programs or commercial supply, BAG Health Care offers the experience, infrastructure, and commitment needed for sustainable partnerships in sterile drug manufacturing.

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Certifications

• EMA (EU GMP)
• World Health Organization (GMP / HACCP)
• MHRA (UK GMP)

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Activity

• Injectables, Terminal sterilization, Fill&Finish, Small volume vials, FDF / DRUG PRODUCTS manufacturing

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Features

• Uses: Investigational, Commercial (Phase IV), Phase I, Phase II, Phase III, Human, Veterinary
• Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day)
• DEA: N/A
• BSL: 1
• Therapeutic areas: N/A
• Markets: EMA (EU), MHRA (UK), TGA (Australia)

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Batch Size / Reactor

• Small, Medium

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Services

• Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Tech transfer, Formulation mixing, Lyophilization, Engineering batches, Registration batches, Batch records, Analytical methods validation, Release testing of raw materials, Release testing of product, Bioanalysis, Analytical methods transfer, QP in house, Batch certification / release, GMP documentation, Primary packaging, Secondary packaging, Labeling, Serialization

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