Soft gelatin capsule development and manufacturing services

OneSource softcaps are the new way to make softgels. We deliver fully integrated, end-to-end soft gelatin capsule (softgel) development and contract manufacturing services, including formulation development, CMC development, and GMP drug manufacturing, supporting complex oral formulations from early development through commercial production. With decades of experience, advanced formulation expertise, and scalable manufacturing, we help transform challenging molecules into high-performance, patient-friendly dosage forms.

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OneSource softcaps provides solutions for a complex and underserved dosage form

Softgel capsules represent a small but highly specialized segment of the oral dosage market, requiring significantly more expertise and infrastructure than conventional tablets or hard capsules.

Unlike other oral formats, softgels combine formulation, encapsulation, and sealing into a single integrated process. This introduces unique challenges across development and manufacturing, but also creates opportunities to deliver superior product performance.

At OneSource, SoftCap programs are supported by a platform designed specifically to manage this complexity, enabling clients to access a technology that is often limited by global capacity and expertise.

3

decades of rich experience in softgel R&D and cGMP manufacturing

2.4

billion capsules manufactured each year

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Global presence – our products are sold in all regulated markets

Enabling better therapeutic performance through softgel technology

The value of softgel capsules lies in how they deliver the active ingredient.By encapsulating the drug in a liquid or semi-solid state, softgels enable faster absorption and improved bioavailability compared to traditional solid dosage forms.

How OneSource softcaps compare to traditional oral dosage forms

Attribute Soft Gelatin Capsules Tablets Hard Capsules
Drug State Liquid or semi-solid (pre-dissolved) Solid Powder or granules
Bioavailability High, especially for poorly soluble APIs Moderate to low for BCS II/IV Moderate
Onset of Action Rapid (no dissolution step required) Slower (requires disintegration + dissolution) Moderate
Dose Efficiency Often reduced dose required Higher dose often needed Moderate
Patient Experience Easy to swallow, taste-masked, visually appealing Can be large, harder to swallow Easier than tablets but less elegant than softgels
Formulation Complexity High (requires specialized expertise) Low (commoditized market) Moderate
Manufacturing Complexity High (multi-step, integrated process) Low Moderate
Best-Suited APIs Poorly soluble, lipid-based, potent low-dose Broad range Broad range
Lifecycle Differentiation Strong (bioavailability + patient preference) Limited Moderate

Development built on deep formulation expertise

Softgel development requires careful alignment between the fill formulation, gelatin shell, and encapsulation process. Small changes in one area can significantly impact product performance and stability.

  • Formulation design for liquid, semi-solid, and lipid-based systems
  • Compatibility assessment between fill and shell components
  • Control of critical parameters such as pH, viscosity, and moisture balance
  • Application of Quality by Design (QbD) principles to define robust operating ranges

Programs typically progress from early formulation through scale-up within a defined timeline, with pilot studies, edge-of-failure analysis, and process optimization conducted before transfer to manufacturing.

This approach ensures that products are not only technically viable but also ready for successful commercialization.

Structured to support a wide range of sofgel formats

OneSource supports a diverse portfolio of softcaps formats, enabling tailored solutions based on therapeutic and patient needs.

Format Use Case Key Benefit
Immediate Release Pain relief, OTC Rapid onset
Delayed / Enteric GI-sensitive APIs Targeted release
Chewable Pediatric / geriatric Ease of administration
Twist-Off Infant dosing, supplements Flexible delivery
SMEDDS Poorly soluble APIs Enhanced absorption

OneSource’s softcaps platform is built on decades of development and manufacturing experience, supported by a library of hundreds of formulations and process models.

This experience enables teams to:

  • Rapidly align new molecules with proven formulation approaches
  • Anticipate and mitigate common challenges such as leakage, instability, or shell interaction
  • Optimize formulations for long-term stability and commercial success

For example, complex molecules prone to leakage or instability can be addressed through tailored formulation strategies and process controls, resulting in products that maintain integrity throughout their lifecycle.

Facilities designed for development and commercial scale

Softgel development and manufacturing at OneSource are supported by a coordinated facility model in Bangalore, with development housed within the global development center and commercial manufacturing executed at the dedicated softgel production site.

This structure enables a seamless transition from formulation development through scale-up and commercial production, ensuring continuity across the full lifecycle.

Manufacturing built for precision and throughput

Softgel contract manufacturing is inherently complex, involving multiple tightly controlled unit operations including fill preparation, gelatin ribbon formation, encapsulation, drying, and inspection.

At OneSource, these processes are executed using advanced rotary die encapsulation systems, supported by automated inspection and packaging technologies.

Manufacturing capabilities include:

  • Batch sizes ranging from 0.1 million to 40 million capsules
  • Capsule sizes from 80 mg to over 2000 mg
  • Flexible production across a wide range of shapes, formats, and fill types

Automated inspection systems ensure consistent product quality by detecting defects such as weight variation, sealing issues, and print inconsistencies, supporting high standards required for regulated markets.

Analytical and in-process control for complex systems

Softgel contract manufacturing introduces additional analytical and in-process control requirements compared to traditional oral dosage forms.

At OneSource, quality is maintained through monitoring of key parameters across all stages of production, including:

  • Gelatin viscosity and ribbon consistency
  • Fill composition and stability
  • Seam integrity and sealing performance
  • Capsule weight, shape, and visual quality

Specialized inspection and analytical tools enable real-time evaluation, ensuring that each unit meets defined quality standards and minimizing defects such as leakage or deformation.

Integration across softgel contract development, manufacturing, and lifecycle management

Softgel programs at OneSource are supported across the full lifecycle, from early development through commercial manufacturing and post-market optimization.

This integrated approach includes:

  • Formulation development services and process development services
  • Scale-up and technology transfer services
  • Commercial manufacturing and packaging
  • Lifecycle management and troubleshooting

By maintaining continuity across these stages, OneSource ensures that products are not only developed efficiently, but also sustained successfully in the market.

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