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Softgel capsule manufacturing technologies

Designed for agility. Backed by experience. Thermo Fisher proprietary softgel technologies

Whether you’re advancing a new molecule or expanding an established product line, softgels offer a versatile and patient-preferred delivery format. This patient-friendly format is especially effective for delivering poorly water-soluble drugs in lipid-based formulations, making it a strong candidate in early development phases.

Thermo Fisher Scientific brings decades of experience supporting softgel development from early-stage formulation through commercial manufacturing. With dedicated facilities in High Point, NC, and Tilburg, the Netherlands, we have the capacity to produce 10 to 12 billion softgels annually. Our scientists specialize in lipid-based delivery systems and softgel technologies to help overcome complex solubility challenges and accelerate clinical timelines. We also support late-stage lifecycle management and OTC product development to help clients extend product lines and drive commercial value.

10–12 billion softgels produced annually

Robust production capacity backed by 28 encapsulation lines to support programs from development through commercial scale.

25+ years of softgel manufacturing experience

A global network of experts delivering trusted support across every phase of development.

7 proprietary softgel technologies and 60 patents

Innovative, customizable delivery solutions with a strong foundation in scientific and technical IP.

What are the softgel advantages?

Rx and early development advantages

  • Enhance solubility and bioavailability of poorly water-soluble molecules
  • Enable lipid-based delivery for improved absorption and therapeutic efficacy
  • Contain highly potent APIs (including Category 3a, 3b, and hormones) with added safety
  • Enable precise control of drug release, content uniformity, and absorption site
  • Support for taste masking, anti-counterfeiting, and patient-centric design
  • Scalable from preclinical development through commercial manufacturing
  • Suitable for light- and oxygen-sensitive compounds

Consumer healthcare and OTC advantages

  • Enable rapid proof-of-concept to gauge market interest
  • Support product lifecycle extensions and brand differentiation
  • Deliver customized softgel formats with proprietary shell and fill technologies
  • Offer solutions for tablet-to-softgel transitions
  • Accelerate time to market with streamlined development and regulatory support
  • Improve patient experience with enhanced mouthfeel and ease of swallowing
  • Enable tailored dissolution profiles to meet specific therapeutic and release requirements
  • Support population-specific needs, including pediatric and geriatric applications

 

Discover the benefits of softgels and our diverse technologies that can meet the needs of your molecules and markets.

 

Softgel capsule development expertise

 

Lipid formulations and early development services: A strategic option for solubility challenges:
 

Lipid-based formulations use oils, surfactants, and self-emulsifying systems to deliver poorly water-soluble drugs more effectively. These systems help keep drugs in a dissolved state throughout gastrointestinal transit, improving absorption and therapeutic performance—especially in early development when conventional approaches often fall short.

Our scientists specialize in lipid-based formulations that improve solubility and bioavailability, including self-emulsifying drug delivery systems (SEDDS) and surfactant-based approaches. These systems are ideal for formulating poorly water-soluble molecules, enabling consistent absorption and faster therapeutic onset. 

Building on this expertise, Thermo Fisher Scientific supports early-stage softgel development with integrated services that span pre-formulation, analytical development, clinical supply, and scale-up—helping customers de-risk development and accelerate timelines.

Benefits of partnering for early development:

  • From formulation to pilot-scale production, all services are coordinated under one global partner.
  • Our teams align early with compliance standards to mitigate risk.
  • Each formulation is customized based on the molecule’s characteristics and target patient needs.

Over-the-counter (OTC) softgel manufacturing services: Comfort, adherence, versality

Thermo Fisher Scientific also brings decades of experience to the development and commercial manufacturing of over-the-counter softgels. Our integrated capabilities support rapid development, compliance, and scale-up—helping brands bring consumer-preferred formats to market efficiently.

Benefits of partnering for OTC development:

  • Comprehensive support from formulation through regulatory approval and commercial production
  • Patient-centric solutions that emphasize ease of use, rapid onset, and taste masking
  • Global facilities operating under strict cGMP standards and aligned with regulatory expectations
  • Agile, large-scale manufacturing to accelerate timelines and adapt to shifting consumer trends
  • Proven expertise across a wide range of active ingredients and therapeutic categories

Softgel products and technologies

Thermo Fisher’s 7 proprietary softgel technologies offer flexibility across prescription, OTC, and consumer health products—supporting delivery needs from fast absorption and taste masking to controlled release and pediatric-friendly formats.

Softgel manufacturing sites

Helpful Resources

Infographic
Bioavailability enhancement technologies for poorly soluble molecules
It’s estimated that about 40% of drugs with market approval and nearly 90% of molecules in the discovery pipeline are poorly soluble. This can impede drug absorption, leading to reduced bioavailability and compromised therapeutic efficacy. Explore how Thermo Fisher Scientific’s Quadrant 2TM platform leverages AI/ML tools to identify solubility enhancement technologies.
Webinar
Lipid formulations in softgels: Enhancing bioavailability and therapeutic efficacy
This webinar explores how lipid formulations can enhance drug absorption and bioavailability and also examines the various types of lipid systems and their applications across therapeutic areas.