Customized Drug Product Solutions

Every drug development path is unique. We have the flexibility to customize our service to your needs, to ensure success and overcome potential obstacles.
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We take a science-first approach and use state-of-the-art technologies to define your program’s optimal data-driven formulation strategy.

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WE ARE INVESTED IN YOUR MOLECULE’S SUCCESS, RIGHT FROM THE START.

You're in safe hands with Serán’s industry-leading technical expertise, quality systems and regulatory support.

We are invested in our clients’ programs and their success, with a shared commitment to the rapid development of better treatments that benefit patients.

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Preformulation Services

Serán’s pre-formulation assessment begins with an in-depth understanding of our client's API and project goals and timelines, right from the start. We use a science-first approach to conduct detailed research into your molecule and state-of-the-art technologies enable us to develop optimized formulations, processes, and analytical methods for your project. We leverage a full suite of analytical capabilities and modeling tools to assess your API with a drug product mindset.

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Formulation Development

Whether you need a simple immediate-release, an enabled formulation with enhanced bioavailability, or a highly engineered controlled-release tablet, Serán has the experience and knowledge to find the best solution for your project. We provide robust, manufacturable and scalable drug products early in development to accelerate and de-risk your path to market.

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Dosage Form Development

Serán specializes in developing versatile solid dosage forms, including capsules, tablets, and powder-in-bottle formulations, as well as a wide variety of other engineered solutions tailored for optimal in vivo exposure and scalability from discovery to clinical trials. Serán’s full investment in a shared commitment to the rapid development of better treatments that benefit patients makes us a reliable partner in your drug development journey.

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Spray Drying and Particle Engineering

Serán has decades of experience in particle engineering, including spray drying. Our deep scientific expertise, formulation and dosage form experience, and technical knowledge form the bedrock of our particle engineering leadership. Our technology enables delivery of drugs to a wide variety of biological targets, including the small intestine to enhance bioavailability, colonic, and pulmonary delivery.

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cGMP Manufacturing

Serán offers clinical manufacturing capabilities for a broad range of oral solid dosage forms including unit operations in particle size reduction, spray-dried dispersions, tablet compression, tablet coating, encapsulation, and clinical packaging and labeling. Whether you are developing a first-in-human asset, or looking to expand to later stage clinical trials, we have a variety of phase-appropriate processes to rapidly advance your drug to the clinic. We are invested in your goals and share a commitment to the rapid development of better treatments that benefit patients.

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Analytical + Quality Control

Serán has extensive solid-state analytical capabilities to assess physical/chemical forms of crystalline and amorphous API and drug products. We offer analytical services spanning method transfer, development, qualification, and a state-of-the-art QC lab to support cGMP release testing and stability assessment. Our culture of innovation delivers ongoing technical and process improvements while pioneering advanced technology strategies to meet future industry needs.

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Spray Drying of Biologics

Serán supports both formulation development and particle design of biologics for improved stability and to enable alternative routes of delivery. From protein therapeutics to lipid nanoparticles (LNPs) carrying RNA, Serán specializes in comprehensive design of solid-state formulations for optimal long-term stability while considering the unique requirements of each target product profile. Spray drying enables the creation of a free-flowing powder and the ability to engineer particle properties. The ability to intentionally design these particles is critical for downstream incorporation and performance in drug delivery systems, including inhalable powders, injectable suspensions, or long-acting implants.

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Our experience and background cover a wide range of pharmaceutical manufacturing concepts bringing our world-class expertise to you and your drug product.

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Drug development solutions

WE ARE INVESTED IN YOUR MOLECULE’S SUCCESS, RIGHT FROM THE START.

Preformulation Services

Formulation Development

Dosage Form Development

Spray Drying and Particle Engineering

cGMP Manufacturing

Analytical + Quality Control

Spray Drying of Biologics

Ready to get started?