Research and development (R&D) will always be one of the central pillars of the pharmaceutical and biotech industry. In 2001, there were just over a thousand pharmaceutical companies with active R&D pipelines, and in 2020, this figure spiked at almost 5,000.
Companies throughout the sector are all too familiar with the time, cost and risks involved in getting a product to market. But evolving patients’ needs and the rewards for meeting them fuel a constant desire to innovate, explore and develop new products. The industry’s focus is to create efficiency wherever possible in development to keep costs low, accelerate time to the clinic and ultimately market and de-risk programs.
The COVID-19 pandemic has shown us that, with the right collaboration, technical expertise and investment, developing and launching a product quickly is possible.
The pandemic presented a unique set of circumstances and while the historical patterns of disease outbreaks and pandemics indicate a repeat is likely in the future – it is unlikely to create a ‘new normal’ for pharma companies. We will return to ‘slower’ development cycles, but relative to the pre-pandemic world, a new collaborative mindset combined with the specialized technological capabilities of outsourcing partners will hopefully catalyze rapid drug development.
Accelerating drug development at Metrics
Metrics Contract Services’ Pharmaceutical Development Lab (PDL) allows us to provide flexibility and speed in early development-stage testing of OSD products in a non-GMP environment. The lab supports a range of non-GMP analytical needs including method development and method qualification for API, pharmaceutical intermediate, finished product and raw materials. Development work can be progressed quickly and subsequently transitioned to the GMP environment at an appropriate stage. Leveraging the PDL can accelerate six months of typical development time to two, or even one month and reduces risk from clinical manufacturing.
All potential projects are evaluated to determine if they are good candidates for the PDL development space.
Our scientists conduct lab-scale experiments, with batch sizes ranging up to 10 kg to refine processes before transferring to GMP manufacturing. The lab allows for in-process testing to determine process end points, level of coating, disintegration and dissolution rates.
Use cases for the Product Development Lab
When developing an OSD formulation, excipient compatibility provides the groundwork for future formulation development. Our scientists leverage a library of formulation blends and accompanying rheology and compressibility data to determine the appropriate functional excipients for the formulation. In the PDL, we can develop both formulation and process efficiently, gaining data and results in a higher throughput environment compared to conventional manufacturing suites.
Sponsors typically know their desired route of administration, dose(s) and site of absorption based on pre-clinical and toxicology data. The next stage (at Metrics) is to develop an OSD form to target the pharmacokinetic absorption. Turning the API into a tablet or capsule dosage form requires both time and material, because each API is unique with respect to in-vivo absorption and distribution. If the API and time constraints require it, Metrics offers neat API-in-capsule manufacturing with its Xcelodose® encapsulator.
In the development and characterization of formulations, utilizing instruments such as the P4 Camsizer is another example of our PDL‘s automation capability which can increase development speeds.
Data and regulatory support
The PDL combines analytical and product development capabilities to deliver near-parallel data during formulation development.
Some therapeutic areas encounter a Phase I to Phase III jump in clinical pathway so formulations must be developed with as much information as possible. With respect to regulatory filings, products with the FDA’s breakthrough designation are often vulnerable as critical quality attributes (CQAs) may be recognized late in the development cycle. To counteract this, the PDL offers the expertise, flexibility and analytical instrumentation such as dissolution and HPLC to provide “close to real-time” data that informs critical process parameters earlier rather than later.
Ultimately, Metrics’ PDL positions a project to transition to the GMP space with risks mitigated, and a stable product formulation ready for manufacturing – all while saving time and cost.
Author: Tom Salus, Senior Business Development Executive