Specialty Injectable Development Platform

Peptide Formulation Technology Platform

Elevating Therapeutic Precision through Advanced Peptide Formulations

Peptide drugs have emerged as a pivotal solution, transcending the limitations of traditional small molecule chemical compounds.

Renowned for their exceptional specificity, peptide drugs use their specific sequence structures and interactions with receptors or proteins, bringing superior targeted therapeutic effects.

Furthermore, due to their high activity and low concentration characteristics, the manufacturing process of peptide drugs requires more specialized analytical techniques, thus regulatory agencies in various countries have stringent requirements for peptide drugs, spanning from product development to manufacturing, necessitating the highest standards of overall quality control.

Our Distinctive Edge and Expertise

At UBI Pharma Inc., we stand at the forefront of peptide injectable product development, with an experienced journey that encompasses every stage of this intricate process, from early assessment of raw materials, structural identification, reverse analysis of reference drugs, to the development of effective analytical methods, process design, and establishment of key process parameters.

Guided by the paradigm of "Quality by Design," our commitment to excellence has culminated in the acquisition of several drug certificates – a testament to our skillset recognized by international regulatory entities.

Our service portfolio include a diverse array of tests that consolidate the quality of end products. This includes the assessment of package compatibility, photostability testing, stringent container closure integrity evaluations (CCIT), residual oxygen analyses, peptide stability assessments, and the qualitative and quantitative analysis of degradation products using cutting-edge LC-MS technologies.

UBI Pharma Inc. stands as your strategic partner of choice. Our comprehensive expertise and innovative prowess equip us to not only meet the demands of an exacting regulatory landscape but also to elevate your peptide drug endeavors to unprecedented heights of success.

Lyophilized Formulation Technology Platform

Precision Beyond Limits • The Art of Lyophilization

Lyophilization, a pinnacle of specialized injectables techniques, transforms medications into an artful of science and precision.

Through meticulous processes executed under high vacuum and low temperature conditions, moisture within the medication is directly sublimated from solid to vapor, resulting in a spongy, porous structure. This unique structure exhibits exceptional rehydration capabilities and contains an extremely minimal amount of water. Even after drying, the volume of lyophilized drugs remains nearly unchanged.

The lyophilization process emerges as a guard of stability, safeguarding the potency of active compounds and amplifying their therapeutic efficacy.

Our Distinctive Edge and Expertise

At UBI Pharma Inc., our commitment to excellence exits throughout every facet of our endeavors. Housed within our state-of-the-art laboratory is a 5 square meter freeze dryer, where lyophilization parameters are meticulously fine-tuned. This translates to a seamless transition from research-driven insights to large-scale production, elevating efficiency in product development.

Besides, our production line freeze dryers are adorned with wireless temperature sensors from Germany, enabling real-time temperature monitoring. The rhythm of precision is further orchestrated by online Process Analytical Technology (PAT), ensureing the utmost control over the production process, reaching the impeccable quality of the final product.

Our research team has achieved significant milestones with multiple lyophilized formulation products, obtaining maeketing approvals for both the US and Taiwan. These achievements underscore our exceptional prowess in this field, able to support to unveil the potential of lyophilization and transcend the boundaries of possibilities.