Approximately 40% of marketed drugs and up to 90% of compounds in development pipelines are classified as poorly soluble. For APIs in DCS Class II and Class IV, low aqueous solubility limits absorption, reduces bioavailability and compromises therapeutic efficacy. Traditional formulation approaches often fail to address these challenges at commercial scale.

Hot melt extrusion offers a robust, solvent-free solution. By heating and mixing crystalline API with polymers, HME creates a stable amorphous solid dispersion where drug molecules are uniformly distributed throughout a polymer matrix. The result: improved dissolution, enhanced bioavailability and better patient compliance through optimized dosing.

AbbVie has been solving these formulation challenges longer than any other CDMO. Our proprietary techniques for assessing HME feasibility, combined with integrated development-to-commercial manufacturing capabilities, reduce risk and accelerate your path to patients.

AbbVie Contract Manufacturing brings unmatched HME expertise to every partnership:

• 30+ years of HME development experience

• 100+ HME development programs completed

• 10 commercially approved products utilizing HME technology (AbbVie and CMO client products)

• 4 global HME sites spanning North America and Europe

• 7 oral solid dose development and manufacturing sites

• GMP extruders from 11mm to 70mm screw diameter

Our leadership in HME formulation and manufacturing, combined with academic collaborations that drive innovation, has resulted in the highest rate of HME technical publications in the industry.

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AbbVie supports the full development lifecycle for hot melt extrusion and amorphous solid dispersions through a structured six-stage program with clearly defined success criteria. 

Stage 1: API Characterization

Assess technical feasibility for ASD formulation and HME process by evaluating small quantities of API. AbbVie employs proprietary techniques to estimate feasibility and predict success rates early in the program.

Stage 2: Formulation Development

Develop prototypes and clinical formulations optimized for your target product profile.

Stage 3: Clinical Manufacturing

Produce GMP clinical supplies at our Lake County, IL or Ludwigshafen, Germany facilities using small scale GMP extruders.

Stage 4: Process Development

Define final dosage form and commercial process train, including critical material properties (CMPs) and critical process parameters (CPPs).

Stage 5: Process Scale-Up

Scale up and optimize the process at commercial scale. Define design space for regulatory filing.

Stage 6: Commercial Manufacturing

Launch commercial production at our Ludwigshafen, Germany, Barceloneta, Puerto Rico (APL) or AbbVie North Dublin, Ireland facilities.

Analytical method development runs in parallel throughout the program to support regulatory submissions.

AbbVie operates one of the largest networks of pharmaceutical extruders in  Europe and North America. This geographic redundancy provides flexibility in manufacturing location and assurance of supply.

Extruder Network

• 10+ GMP extruders across the network

• 11mm to 70mm screw diameter range

• Potent compound capability (<1 μg/m³)

• Experience with both ASD and melt granulation processes

Commercial Sites

• Barceloneta, Puerto Rico (APL)

• Ludwigshafen, Germany

• AbbVie North Dublin, Ireland

Downstream Manufacturing Options

• Controlled release formulations

• Modified release formulations

• Tablets

• Mini-tablets

• Capsules

Packaging Options

• Blister

• Bottle

• Sachet/Stick

• Wallet

Our integrated approach means your HME intermediate flows seamlessly into downstream oral solid dose processing, final packaging and release testing — all within the AbbVie network.

AbbVie has launched 10 commercial products utilizing HME technology, one of the most in the pharmaceutical industry.. Our commercialization expertise spans antiviral, antifungal, hepatitis C, oncology and neuroscience therapeutic areas.

This track record demonstrates our ability to navigate the technical, regulatory and operational challenges of bringing HME-based products from development through commercial launch and ongoing supply.

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• Improved bioavailability for poorly soluble APIs

• Solvent-free — no organic solvents required

• Efficient process to create amorphous solid dispersions

• Continuous manufacturing process with high throughput

• High process understanding and control

• Robust manufacturing process that is readily scalable 

• The potential for reduction in number of doses

• The potential to simplify storage conditions and remove food effects

AbbVie Contract Manufacturing is a seasoned partner for all your hot melt extrusion needs. Whether you're evaluating HME feasibility for a new compound or seeking a commercial manufacturing partner for an existing program, our team is ready to help.

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