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
Preformulation & FIH Formulation Design
From discovery to commercial, our formulation design team has you covered. With the evolution of enabling technologies, low solubility no longer limits the advancement of molecules from discovery to clinical candidacy.
We evaluate critical physicochemical properties of the API that, through first principle models, provide insight into bio-performance and thermodynamic interactions with excipients to guide technology selection and formulation design of an enabled intermediate, if needed. This fundamental understanding allows for the flexibility needed to deliver formulations to meet your pre-clinical and clinical goals.
Enabling Technologies for Pre-clinical Formulations
Enabling Technologies for Clinical Formulations
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.
QUALITY CONTROL
cGMP Manufacturing
Serán provides 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 extensive spray drying capabilities. Our team has decades of experience developing spray drying processes, related formulations, and analytical methods and techniques. We have leveraged our core knowledge of particle engineering and formulation requirements to design and build optimum spray drying systems for pharmaceutical applications. 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 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.
Analytical & Quality Control
At Serán, our culture of innovation drives us to provide top-tier analytical services that meet the rigorous demands of our clients’ projects. Our team, led by respected industry veterans, operates under a unified approach that de-risks each project from the outset. We are committed to our robust analytical and quality principles, ensuring our highly skilled team delivers results you can trust. Our focus on flexibility allows us to maintain strict adherence to methods and processes while keeping your project milestones on track. Our comprehensive suite of analytical services includes method transfer, development, qualification, and a cutting-edge QC lab designed to support cGMP release testing and stability assessment and storage.
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.
Analytical Services & Support
SupportSerán’s analytical labs deploy a variety oftechniques to assess the physical andchemical properties of drug substances andprototype formulations. Careful collectionand evaluation of the right data enablesrational scientific choices leading tooptimized formulations.
Developing Advanceable Formulations
Serán has developed a novel drug-product-development paradigm that enables first-in-human drug product (preferably a tablet) that can be scaled to a commercial presentation with minimal time and cost. This proprietary “right from the start”™ approach utilizes state-of-the-art materials science and computational methods to dramatically reduce cost and increase speed and flexibility as a product advances through early-stage development into late stage and commercial manufacturing.
Nano Milling for Advanced Bioavailability
Nanocrystalline drug products offer an alternative to amorphous dispersions for some compounds that require enhanced bioavailability. A nanocrystal approach is preferred for APIs that rapidly crystallize from an amorphous state, exhibit temperature-dependent chemical instability, or are poorly soluble in common solvents used for spray drying.
Targeted Protein Degraders
Protein degrades have shown promising clinical outcomes utilizing a novel degradation-based mechanism. However, adequate oral bioavailability remains a significant challenge for these large complex molecules due to low solubility and permeability. Serán’s expertise formulating complex molecules has resulted in a track record of success for clients with these challenging molecules. By using science-based formulation approaches, a large number of tools, including ASD, permeation enhancers, and other state of the art technologies.
Hot Melt Extrusion
In addition to our wide range of technology solutions for poorly soluble compounds, Serán offers Twin Screw Extrusion for Hot Melt Extrusion (HME) and granulation.
On-Demand Presentation: High Concentration Protein Suspensions: A Bevacizumab Case Study (>400 mg/mL)
Dr. Cindy Chung presents a case study demonstrating the development of high concentration bevacizumab suspension at up to 400 mg/mL for suitable subcutaneous delivery of the monoclonal antibody (mAb) therapy. Watch the presentation now to learn more.
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.
Posted Date: 12/1/2023
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