Serán Bioscience, LLC
63047 Layton Ave.
Bend, OR  97701
T:  (541) 797-2148
E: Hello@seranbio.com
W: seranbio.com
LinkedIn: https://www.linkedin.com/company/seran-bioscience/

 

Serán BioScience, LLC is a sci­ence-based CDMO that specializes in a variety of drug delivery and formu­lation approaches suited to optimizing bioavailability. Serán’s experienced formulation team will work with you to identify an appropriate technology and formulation strategy to meet your program’s unique needs. Our comprehensive approach to formulation design considers the physiochemical properties of the API, the target product profile, and your program’s objectives and constraints to develop scalable formulations using efficient and material-sparing approaches.

Whether considering enabling technologies (amorphous solid dispersions, lipid formulations, particle size reduction techniques) or conventional approaches, we comprehensively assess technology options to consider bio-performance, stability, manufacturability, and drug product design – aiming to deliver you the simplest approach that meets your program’s needs.

Serán provides capsules (enteric or IR), tablets (from minitablets to large format caplets), multi-particulates (coated beads), and powder-in-bottle formulations. Our solid dosage forms are engineered for a wide range of formulation approaches such as overcoming solubility challenges and to enable extended-release. We complement industry-best production practices with the finest manufacturing equipment available to produce dosage forms that perform predictably and reliably.

OUR SERVICES

GMP Manufacturing

We provide 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. If 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.

Spray Drying & Particle Engineering
Serán has decades of experience in particle engineering, including spray drying. Our technology enables delivery of drugs to a wide variety of biological targets, including the small intestine to enhance bioavailability, colonic, and pulmonary delivery.

Solid Dosage Forms
Serán Bioscience specializes in developing versatile solid dosage forms including capsules, tablets, and powder-in-bottle formulations, and a wide variety of other engineered solutions tailored for optimal in vivo exposure and scalability from discovery to clinical trials.

Formulation Development
For early discovery and toxicology studies, we utilize a variety of suspension and solution approaches to obtain desired in vivo exposure, especially at high doses. As you advance to the clinic, our solid dosage form approaches are designed to achieve your preferred performance and are engineered for scalability.

Analytical
Serán has extensive solid-state analytical capabilities to assess physical/chemical forms of crystalline and amorphous API and drug products. We have analytical services spanning method transfer, development and qualification, and a state-of-the-art QC Lab to support GMP release testing and stability assessment.

Regulatory & IND Support
Our staff has decades of experience in drug development and understands the challenges and solutions that each project requires. Our regulatory and quality team will work with your team to develop phase-appropriate strategies for rapid advancement.

Media Center

Dosage Form Design
Serán is your development partner for all oral solid, and inhaled particle needs. Focusing on what’s right for the patient with scalable and advanceable formulations allows Serán to deliver the flexibility customers need for their programs.

 

 

Serán Spray Drying
A large percentage of new chemical entities exhibit poor aqueous solubility resulting in low bioavailability. Serán utilizes a wide variety of technology approaches to overcome these bioavailability challenges.

 

 

 

Particle Engineering
There is a growing interest across the industry in developing technologies for subcutaneous delivery of high dose protein therapeutics. High concentration protein solutions are limited by viscosity and stability; both phenomena are driven by protein-protein interactions in solution. Three primary approaches have emerged to overcome the technical challenges associated with high dose delivery: viscosity reducing excipients, high volume delivery, and high concentration suspensions.

 

ARTICLE: Designing Advanced Formulations & Processes at Phase 1
The primary criteria for successful drug development and commercialization have long been established: any new pharmaceutical product must be safe and effective, and it must be both manufacturable and commercially viable. Historically, demonstrating safety and efficacy was sufficient to advance a drug candidate through clinical trials. However, as timelines have accelerated and the market continues to become more competitive, the risks associated with manufacturability and commercial viability have drawn more attention, and drug developers are increasingly seeking approaches to address these concerns at earlier stages of product development. This shift in emphasis and timing demands an appropriate deployment of tools, processes, and methods, which means establishing partnerships with contract development and manufacturing organization (CDMO) partners who share this vision. In this new landscape, success hinges on the ability to navigate the intersection of science, technology, and commercial readiness, driving an increasingly proactive and agile approach to drug
development.