Phase-appropriate formulation development means designing formulations that match the requirements of the development stage rather than over-engineering early-phase work. Formulations are aligned to your quality target product profile and structured to evolve seamlessly through clinical phases – ensuring they remain clinically suitable, regulatory-ready and ready for downstream manufacturing without unnecessary rework.
Bringing a pharmaceutical product from concept to clinic requires robust formulation design supported by deep scientific understanding. Solubility, stability and bioavailability challenges – particularly for complex molecules and sensitive live biotherapeutic products – can compromise clinical performance, regulatory progression and downstream scale-up if not addressed through structured, phase-appropriate development.
We provide specialist formulation development services for small-molecule and live biotherapeutic products, supporting programs from early development through first-in-human and proof-of-concept studies. Our phase-appropriate approach ensures formulations are clinically suitable, regulatory-ready and designed to evolve seamlessly into downstream manufacturing – while any intellectual property generated remains fully owned by you.
Develop formulations that progress with confidence
- Address complex molecule challengesOur scientists specialize in low-solubility, low-bioavailability APIs and sensitive live biotherapeutic products, applying targeted strategies to overcome formulation barriers.
- Develop fit-for-purpose formulationsPhase-appropriate development aligned to your quality target product profile supports efficient transition into clinical studies.
- Retain full ownership of formulation IPWe operate on a fee-for-service model, ensuring all intellectual property generated through formulation development remains fully owned by you.
- Move seamlessly into GMP manufacturingFormulation development is closely aligned with our downstream GMP manufacturing capabilities, minimizing risk during scale-up and clinical supply.
- Access broad dosage form expertiseWe support development across multiple dosage forms, from oral solids and liquids to semi-solids and targeted microbiome delivery systems.
Our formulation development capabilities
Small-molecule formulation development
We provide formulation development and optimization for a wide range of small-molecule APIs, including compounds with challenging physicochemical properties. Supported dosage forms include solid oral dose forms (capsules, tablets, mini-tablets and multiparticulates), immediate and modified-release formulations, liquid and semi-solid filled capsules, oral liquids and suspensions, topical and semi-solid products, and non-sterile parenteral formulations.
Live Biotherapeutic Product (LBP) formulation
We are one of the few Contract Development and Manufacturing Organization’s (CDMOs) licensed to develop and clinically manufacture live biotherapeutic formulations, with strategies designed to protect viability and enhance therapeutic performance. Our LBP capabilities include targeted-release oral dosage forms to improve microbiome survival, formulation and process design to minimize oxygen exposure, and primary and secondary packaging concepts aligned to shelf-life and patient requirements.
LBP modality experience
We work across a broad range of LBP modalities. These include single-strain and consortia products, anaerobic and genetically modified microbes, faecal microbiota transplant (FMT) donor materials, bacteriophage and virus-like particles (VLPs), spores, cell lysates, extracellular vesicles, pre- and post-biotics, and LBP–peptide combinations.
Why SGS?
As the world-leading testing, inspection and certification company, our formulation development services combine deep scientific expertise with one of the few CDMO licenses globally for the clinical development and manufacture of live biotherapeutic products. We bring specialist capability across small-molecule optimization and complex biotherapeutic formulation, supported by integrated GMP manufacturing and analytical capabilities.
Backed by our global testing, inspection and certification expertise, we deliver the technical depth, regulatory awareness and operational continuity needed to move formulations confidently from concept through clinical supply.
FAQs
We support a wide range of dosage forms across small-molecule and live biotherapeutic products, including:
- Solid oral dose forms – capsules, tablets, mini-tablets and multiparticulates
- Immediate and modified-release formulations
- Liquid and semi-solid filled capsules
- Oral liquids and suspensions
- Topical and semi-solid products
- Non-sterile parenteral formulations
- Targeted-release oral dosage forms for microbiome delivery
Yes. We are one of the few CDMOs licensed to develop and clinically manufacture live biotherapeutic formulations. Our capabilities cover targeted-release oral dosage forms to improve microbiome survival, formulation and process design to minimize oxygen exposure, and packaging concepts aligned to shelf-life and patient requirements.
We work across a broad range of LBP modalities, including single-strain and consortia products, anaerobic and genetically modified microbes, faecal microbiota transplant (FMT) donor materials, bacteriophage and virus-like particles (VLPs), spores, cell lysates, extracellular vesicles, pre- and post-biotics, and LBP–peptide combinations.
You do. We operate on a fee-for-service model, which means all intellectual property generated through formulation development remains fully owned by you – including formulation strategies, process know-how and analytical methods developed during the program.
Our formulation development is closely aligned with our downstream GMP manufacturing capabilities. This integration helps minimize risk during scale-up and clinical supply, supporting a smoother transition from formulation design into clinical and commercial manufacturing.
Yes. Our scientists specialize in addressing the challenges presented by low-solubility, low-bioavailability APIs and other complex molecules. We apply targeted formulation strategies to improve solubility, stability and bioavailability, supporting clinical performance and downstream manufacturability.
Quay House, 28 Parkway Deeside Ind. Park,
CH5 2NS,
Flintshire, Wales, United Kingdom