Unparalleled Flexibility in Scale and Dosage
Boehringer Ingelheim BioXcellence™ offers the entire biopharmaceutical contract manufacturing chain under one roof. From formulation and filling to visual inspection – with our more than 35 years of experience producing more than 25 million units per year, we tailor our products and services to the needs of our customers. As a consequence, we are a leader in aseptic processing of biopharmaceutical medicines with a track record of more than 20 drug products.
Products manufactured on our modern filling lines are approved by regulatory authorities around the world. In our isolator or RABS-equipped aseptic facilities with nine aseptic filling lines and six freeze driers, we offer flexible vial and batch sizes from 1,000 to 25,000 units to accommodate your needs. We also provide filling services for user-friendly syringes and produce liquid or freeze-dried preparations in vials for clinical and commercial supply.
We make your product just the way you need it.
Our Offer in Fill & Finish
- Eight aseptic filling suites (nine filling lines) – Fill & Finish around our whole global network
- Flexible filling volume between 0.7 mL to 100 mL for vials, 0.4 mL to 10 mL for syringes
- Solutions, highly concentrated liquid formulations and freeze-dried (lyophilized) powders
- Visual inspection as a 100% control
- Visual Inspection process includes manual control for syringes and vials and camera control for vials
- Electronic batch record and barcode-controlled application of material and equipment
- Lot sizes ranging from 3,000 - 150,000
Our Offer in Dosage Forms
Our broad range of Fill & Finish product lines reaches from liquid and lyophilisate vials to pre-filled syringes.
Our broad range of Fill & Finish product lines reaches from liquid and lyophilisate vials to pre-filled syringes.
Vials
- State-of-the-art multi-product aseptic facilities
- Commercial and clinical volumes
- Vials are filled under state-of-the-art conditions within a restricted access barrier system (RABS) or isolator
- Flexible vial sizes and filling volumes from 0.7 - 100 mL
- Flexible lot sizes ranging from 1,000 to 150,000 units
Syringes
- State-of-the-art multi-product aseptic facilities
- Commercial and clinical volumes
- Syringes are filled under state-of-the-art conditions within a restricted access barrier system (RABS) or isolator
- 1 mL, 2.25 mL glass and 10 mL plastic syringes with fill volumes of 0.4 - 10 mL delivered ‘Ready To Use’ (RTU) by qualified suppliers of primary packaging
- Flexible lot sizes from 9 - 12 K at pilot scale and 25 - 150 K at commercial scale
- Manual 100% visual inspection
- Ready-To-Use stoppers
Freeze-dried (lyophilized)
- State-of-the-art multi-product aseptic facilities
- Commercial and clinical volumes
- Vials are filled under state-of-the-art conditions within a restricted access barrier system (RABS) or isolator with automated loading systems
- Six operating freeze dryers
- Flexible lot sizes ranging from 1,000 to 114,000 units
- Flexible vial sizes (2 mL to 100 mL) and filling volumes of 0.5 mL to 50 mL
- Manual and camera controlled 100% visual inspection
- 2 lyophilizers with Controlled Nucleation (under implementation)
Leader in aseptic processing of biopharmaceutical medicines – Freeze-dried Vials
Boehringer Ingelheim BioXcellence™ offers filling services of freeze-dried preparations in vials for clinical or commercial supply. To accommodate your needs, we offer flexible vial and batch sizes from 1,000 to 25,000 units.
Leader in aseptic processing of biopharmaceutical medicines – Liquid Vials
Boehringer Ingelheim BioXcellence™ offers filling services of liquid preparations in vials for clinical or commercial supply. To accommodate your needs, we offer flexible vial and batch sizes from 1,000 to 25,000 units.
Fill & Finish services for vials & syringes
From formulation and filling to visual inspection – with our more than 30 years of experience producing more than 25 million units per year, we tailor our products and services to the needs of our customers.
