Flexibility and speed are important considerations in any drug development process. The Pharmaceutical Development Lab (PDL) at Metrics Contract Services enables us to provide both through efficient early development-stage testing in a non-GMP environment. Moreover, it supports a range of non-GMP analytical needs including method development and method qualification for API, pharmaceutical intermediate, finished product and raw materials. The lab offers flexibility and speed, allowing for in-process testing to determine process end points, level of coating, disintegration and dissolution rates. Development work can be progressed quickly and subsequently transitioned to the GMP environment at an appropriate stage. It expedites the overall timeline to clinic and removes risk from clinical manufacturing activities. The results are fast and direct, enabling pharmaceutical scientists to make decisions on the spot.
Metrics’ scientists are able to conduct lab-scale experiments, with batch sizes ranging from one gram to 10 kg, in order to refine processes before transferring to GMP manufacturing. For example, when developing an oral solid dose formulation, excipient compatibility provides the groundwork for the formulation development. Our scientists, using their library of formulation blends and accompanying rheology and compressibility data, determine the appropriate functional excipients for the formulation. In the PDL, we can develop both formulation and process in a highly efficient setting, gaining data and results in a higher throughput environment than conventional manufacturing suites.
From pre-clinical and toxicology information in animal models, Metrics’ clients will typically know the route of administration, dose(s), and site of absorption. Our pharmaceutical scientists develop the solid oral dosage form to target the pharmacokinetic absorption. Turning the nascent 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. Though not exclusively a PDL offering, if API and time are further constrained, Metrics offers neat API-in-capsule manufacturing with its Xcelodose® encapsulator.
Our passion is to solve our clients’ problems. This often involves development and characterization of a formulation. In that connection, utilizing instruments such as the P4 Camsizer is an example of the PDL ‘s automation capability. The combined analytical and product development suite gives Metrics the means to deliver near-parallel data during formulation development. The suite houses standard analytical instrumentation such as dissolution and HPLC to provide “close to real-time” data in order to prove or disprove a critical process parameter earlier rather than later. Some therapeutic areas encounter a Phase I to Phase III jump in clinical pathway; hence, a formulation must be developed with as much information as possible. With respect to their regulatory filing, products with FDA’s breakthrough designation are vulnerable in the sense that critical quality attributes (CQAs) may be recognized late in the development cycle. To counteract this potential deficiency, Metrics’ PDL has proven to give its scientists the flexibility and tools they need to define CQAs and develop necessary process parameters early.
We evaluate all potential projects to determine if they are good candidates for the PDL development space. Leveraging the PDL can sometimes mean the difference between six months of typical development time and one or two months. The non-GMP lab testing – for suitable projects – helps streamline processes, improves timelines, and decreases risks from clinical manufacturing activities. Our scientific team can tailor release testing programs to client requirements and can provide services for the most basic of tests to more specialized techniques.
Ultimately, Metrics’ PDL advantage positions a project to transition to the GMP space with potential time-consuming issues already resolved. Risks will have been mitigated, and the product formulation is stable and ready for manufacturing – all while saving time and cost.
At Metrics Contract Services, we continue to work with clients to understand their formulation and analytical needs and leverage our experience to develop solutions that meet quality, compliance and throughput requirements.