Phase One: Molecule Lifecycle Brief

14th Feb 2023

Delivering a high-quality product for clinical trials

 

Phase I clinical trials are critical for assessing a drug product’s safety and dosage.1 As the product is tested in humans for the first time, it is imperative to have a full understanding of the product and any associated risks. In addition, it is critical to set and maintain only the highest quality standards for the product and its manufacturing processes.

With regulatory, analytical, technological and other considerations all top-of-mind, navigating phase I clinical trials can be overwhelming for pharmaceutical organisations. A partner with comprehensive capabilities and multidisciplinary expertise can help anticipate, identify and overcome key challenges that arise during phase I to protect patients and accelerate your path to market.

Below are some key areas that can present challenges for pharmaceutical and biotechnology organisations through phase I clinical trials:

Regulatory considerations

During phase I, it is important to set standards for compliance that will continue throughout the entire project. Key focuses include selecting a regulatory starting material, benchmarking quality and other properties as the project progresses, and determining cGMP manufacturing controls.
Working with an outsourced partner that has a strong foundation of regulatory knowledge and understands the full-lifecycle implications of regulatory decisions can dramatically simplify this process.

Analytical requirements

As phase I trials are important for assessing a product’s properties, robust supporting data is needed to affirm quality and safety. Analytical expertise is also needed to ensure high quality process design in areas like method development and validation. In addition, it is critical to evaluate any impurities that may form in the product, and mitigate any that may be harmful. Make sure your outsourced partner has extensive experience working with a broad range of analytical techniques and supporting rigorous data requirements for clinical trials.

Emerging technologies

With the rising complexity of molecules in the pipeline today, innovative technologies are increasingly becoming an important aspect of API development and manufacturing. Capabilities like biocatalysis, continuous processing, hazardous chemistry and more are seeing wider demand, which stems from their ability to unlock new efficiency, quality and safety. Successfully harnessing these technologies, however, requires a partner with specialised expertise. Look for a partner with hands-on experience working with these technologies and a dedicated programme to vet and embrace new technologies as they emerge.

Repeatability and scalability

It is also important to consider the project in its entirety during phase I. Will the processes utilised for small-scale manufacturing translate well to the commercial scale? Looking at phase I in the context of an entire project, through to commercial manufacturing, can help to proactively spot and overcome challenges that may arise in later stages. Selecting a partner with a full-lifecycle service offering will ensure a long-term view that maximises scalability and mitigates unanticipated challenges in subsequent phases of development.

At Sterling, our team has extensive experience supporting our customers in navigating phase I clinical trials and preparing for entry into phase II. As a PDMO®, or partnership development and manufacturing organisation, our services don’t end there. We support our customers’ molecules throughout their entire lifecycle, from discovery, through clinical trials, and commercial launch.

Delivering world-class support through clinical trials

Service

We pride ourselves on being easy to do business with, removing layers of complexity, maximising flexibility and adaptability to your requirements, and doing what we say we will do—again and again.

Passion

We promise to treat your molecule as our own, drive progress by continually exploring new and emerging capabilities, and do the right thing for people and planet.

Science

We combine our expertise in complex and hazardous chemistry, our world-class facilities, and our full lifecycle capabilities to place scientific excellence at the core of every solution we deliver.

At Sterling, we have the specialised teams, state-of-the art facilities and equipment, and extensive expertise to support our customers’ molecules through every stage of their journey to market—from early phase development through to full commercial manufacturing.

Here’s how we support our customers through phase I clinical trials:

Our regulatory expertise enables us to help customers ensure continued compliance and enhance their chances of approval. We help our customers adhere to cGMP guidelines where necessary, determine an appropriate regulatory starting material, assess and mitigate impurities, and more. As a committed partner to our customers, we help them carefully balance regulatory considerations with speed and cost every step of the way.

We understand the importance of emerging technologies in pharmaceutical development, which is why we established our Technology and Innovation Programme. Through this programme, we partner with leading technological and academic institutions to vet, apply and expand our capabilities in innovative technological areas like biocatalysis, fluorination, continuous processing and more.

As a full-service partner, we have experience supporting projects from discovery to commercial manufacturing, from grams to tonnes. This enables us to carefully anticipate any hurdles that may arise in later stages of the molecule’s journey to market and take measures to proactively overcome them in early clinical stages.

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