As you might expect, "first in human" refers to the initial stage of clinical trials for a new drug or therapy, in which clinicians administer the experimental treatment to human subjects.
In the context of biopharmaceuticals, it explicitly indicates the first time clinicians evaluate a novel drug, biologic, or therapeutic agent for its effectiveness in the human population.
However, before reaching the first-in-human stage, potential treatments typically undergo extensive preclinical testing in laboratory settings and animal models to assess safety, efficacy, and possible side effects.
Once preclinical studies provide promising results, researchers proceed to the "first in human" phase to evaluate the treatment's safety profile, dosage, and potential adverse effects in human subjects.
The first-in-human trial is a critical milestone in drug development. Clinicians typically conduct the safety studies in a small group of healthy volunteers and later in patients with the target disease or condition.
The primary objectives of these trials are to assess the treatment's safety, pharmacokinetics — how the drug is absorbed, distributed, metabolized, and excreted by the body — and preliminary efficacy data.
The results of first-in-human trials help inform subsequent phases of clinical development. These include larger-scale studies designed to further evaluate the safety, efficacy, optimal dosage, and potential benefits compared to existing treatments.
In the world of biopharma development, patient safety is the benchmark for all drug development efforts. Accordingly, many hurdles must be cleared before bringing new therapeutic drugs to the "first in human" stage.
However, when it comes to helping small- to medium-sized biopharma companies obtain their clinical trial materials and overcome those hurdles, the team at Ascendia Pharmaceutical Solutions distinguishes itself for its track record of consistently paving the way and anticipating issues before they become major problems.
Navigating the complexities of clinical trials demands precision, reliability, and cutting-edge technology in the dynamic biopharmaceutical landscape. At Ascendia, we pride ourselves on our commitment to excellence in development of clinical trial materials (CTMs) by leveraging our world-class enabling technology and expertise to propel your projects forward.
Ask our clientele. Ascendia stands out at the forefront of formulation development, offering a comprehensive suite of services tailored to meet and exceed our client's evolving expectations.
Our journey began with addressing formulation challenges for novel compounds, growing steadily into clinical trial manufacturing for early-phase trials. Recently, we've expanded our capabilities by introducing a state-of-the-art sterile manufacturing suite poised to redefine the standards of injectable product manufacturing for commercialization.
Central to our commitment to innovation is introducing cutting-edge equipment and processes designed to streamline manufacturing and enhance product quality. Our new sterile clean manufacturing suite boasts advanced features, including a nanomilling machine equipped with aseptic technology, enabling the aseptic processing of sterile nanosuspensions for various administration routes.
Moreover, our suite houses a precision Nanosystem tailored for lipid nanoparticles production alongside high shear jet and high-pressure homogenizers capable of generating lipid nanoparticle emulsions or suspensions. With flexible fillers for vials, pre-filled syringes, and cartridges, we ensure minimal waste and maximum efficiency across batch sizes of up to 30,000 units.
In a landscape marked by innovation and competition, Ascendia's capabilities stand unrivaled. Our sterile manufacturing suite encompasses ISO-certified clean rooms and processing areas, augmented by cutting-edge airlock systems to maintain stringent quality standards throughout production.
Notably, our aseptic processing capabilities extend beyond mere formulation, enabling us to manufacture and finish compressed dosage forms with unparalleled precision. Whether through 0.22-micron filtration or rigorous aseptic processing, we ensure uncompromising sterility and product integrity from inception to completion.
What sets Ascendia apart is our state-of-the-art facilities and unwavering commitment to partnership and innovation. With a keen focus on technology and design, we empower our clients to navigate the complexities of clinical trials with confidence and efficiency.
From formulation challenges to clinical trial manufacturing and beyond, Ascendia is your trusted partner every step of the way. Our expertise and cutting-edge technology ensure that your biopharma projects remain on the fast track to clinical success.
As you embark on your journey in biopharmaceutical development, seize the opportunity to collaborate with Ascendia. Our technology, expertise, and unwavering commitment to excellence are poised to transform your vision into reality.
Reach out to Ascendia today and discover how our tailored innovative solutions can accelerate your biopharma projects toward success. Together, let's redefine the future of clinical trials for unmet medical needs.