Small Molecule Manufacturing Technology

Your Partner for Small Molecule APIs & Drug Products

When it comes to small molecule outsourcing, choosing a reliable, flexible and robust CDMO is crucial for securing your supply chain. With a proven track record and decades of expertise, our Small Molecules platform provides comprehensive small molecule API and drug product development and manufacturing across a wide range of commercial therapeutics.

We enhance your small molecule projects with a global network of facilities that seamlessly integrates the entire range of manufacturing, from early phase development to commercialization, providing both APIs and drug products with a number of major dosage forms.

Process Development
APIs
Drug Products

Process Development

Whether you’re navigating a medicinal chemistry route or implementing a fully-developed small molecules process, our skilled team is ready to assist. Comprised of highly experienced development chemists and engineers, our experts support you in scaling up your process in a phase-appropriate manner, while offering a keen understanding of your future regulatory requirements.

Our aim is not just to produce a scalable route today, but to create a robust, lasting comprehensive control strategy using the principles of Quality by Design (QbD). This strategy helps enable your chemistry to be readily scalable, as we advance your small molecule project from early clinical phase to commercial production.

Our small molecule API development services include:

Route selection
Process development & optimization (early to late-stage, small to large-scale)
Analytical development & validation services
Synthesis & purification of analytical reference standards
ICH stability studies

APIs

Our extensive network of facilities, utilizing multi-purpose equipment, enables on-time delivery of your project within budget and to the highest quality standards, from early-phase development through to commercial manufacture.

With over 200 years of combined manufacturing experience across multiple small molecule facilities in Europe and the US, our extensive expertise in a diverse array of chemical technologies provides flexibility of supply and scale with reactors ranging from 25 L to 28,000 L.

Our small molecule API manufacturing capabilities include:

API development (QbD)
Clinical manufacturing of APIs & advanced intermediates
Commercial manufacturing of APIs & advanced intermediates
Generic APIs

Drug Products

Offered as an integrated solution under the Small Molecules platform, we supply a variety of final drug product dosage forms (e.g. tablets, capsules, vials, cartridges and Pre-Filled Syringes). Our end-to-end services include project management, packaging / labeling and serialization in globally approved facilities.

Our small molecule drug product manufacturing capabilities include:

Solid oral drug products (tablets & hard capsules)
Terminally sterilized injectable drug products (barrel syringes, vials & ampoules)
Aseptic-filled injectable drug products (cartridges, vials & PFS)
Packaging, labeling & serialization

Your Benefits > Our Strengths

1) Guidance Throughout the Entire Drug Lifecycle > Development Experience

We know what you need before you realize you need it. Your project will benefit from our extensive expertise and capabilities in process development, scale-up and manufacturing.

2) Faster Time to Market with Reduced Cost > Streamlined Fully Integrated Supply

Speed up your program with our one partner – one source philosophy to enable faster times to clinical trial and market with reduced costs, from drug substance to drug products and packaging services.

3) Proven Production Capabilities > Our Experience is Your Foundation

Access over 200 years of combined small molecule manufacturing experience with over 100 years of cooperation with the FDA and the EMA. Our facilities offer approximately 1.2 million liters of volumetric reactor capacity and hundreds of millions of tablet and capsule manufacturing capacity to focus on your asset via an integrated product offering.

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Small Molecules brochure

Seamless Integration Across the Supply Chain

Working and coordinating with several providers can be demanding and time-consuming when outsourcing a project. We strive to simplify your journey, improving efficiency and reducing costs by consolidating multiple services in one organization. As your CDMO partner, we work alongside you to understand and anticipate your project needs.

We deliver them through seamlessly integrated technologies and services from across our expert global network designed to support the development and manufacture of pharmaceutical and biotech innovators’ complex modalities. Our bespoke end-to-end solutions span your supply chain, covering all stages from drug development to commercialization.

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