The growth in outsourcing is one strategy life science innovators are pursuing to address the evolving pharma landscape; however, should a sponsor company seek the traditional route of utilizing multiple partners across the supply chain or does an integrated CDMO offer a more efficient and faster path to commercialization?
In the pharmaceutical industry, “technology transfer” refers to the processes that are needed for successful progression of stages ranging from drug discovery, product development, clinical trials to full-scale commercialization or it is the transfer between development and commercialization at different sites within or outside an organization.
The $330 bn global sterile market is expected to reach $525 bn by 2020, growing at a CAGR of 11% -with North America contributing 48% while APAC is expected to record highest CAGR of 13%.
Despite this tremendous growth, drugmakers still face a number of challenges in the manufacturing process for ADCs. Here are key areas where pharma manufacturers face the biggest uphill battles.
While forecasts can never be 100 percent accurate, the goal for biopharmaceutical forecasters should be to minimize the degree of inaccuracies as much as possible.
By thinking outside of the box, CDMOs can create a flexible and scalable business model that offers a level of assurance in the face of forecast variability.
The consequences of inaccurate demand forecasting can be reputational damage, market share loss, lost days of production, destruction of inventory, and layoffs.
Xhale, Inc., a commercial stage medical technology company, had developed the SMART® Medication Adherence Monitoring System technology to non-invasively monitor adherence to oral medications. Efficient encapsulation of 2-butanol has to overcome many challenges, which requires optimization of not only chemical composition, but also manufacturing parameters such as lower processing temperature and thinner softgel shell.
Almac has developed a flexible paediatric dosage form consisting of minitablets filled into stickpacks using a robust manufacturing and filling process suitable for routine commercial manufacture.
Manufacturing of biological and small molecule drug products is on the rise, and more often than not, generation of stability data and getting product released for clinical trials are on the critical path to approval. Emergent Camden not only understands that, but delivers quality product in timelines significantly shorter than other contract manufacturers.