Oral solid dosage
OSD manufacturers face mounting pressure on all sides to make production more cost-effective. Combined with the increase in high-potency products, the emergence of new innovative delivery platforms, competition from generic manufacturers and growing regulatory requirements, OSD manufacturers are left with quite a challenge.
Manufacturing facilities for oral solid dosage form (OSD) products are still the most common pharmaceutical manufacturing facilities. However, most of the traditional blockbuster OSD products are now off-patent and the new OSD products – which are more high potency products - are typically for smaller volumes, requiring a high flexible manufacturing set-up.
Consequently, Europe and the US are experiencing overcapacity and a need to update aging facilities to become more flexible. Meanwhile, the trend in emerging markets goes towards greenfield facilities with high flexibility in terms of throughput and process technology, driven by product transfers.
At the same time, OSD manufacturers are facing pressure on all sides to make production more cost-effective. New high-potency drugs are launched every year, with innovative delivery platforms such as sustained release, sprays and chewing gum entering the market. Simultaneously, generic manufacturers are increasing production capacity, while there is a general shift to produce in emerging markets.
High-potency products drive a high regulatory demands
In addition to flexibility and cost effectiveness, a key priority for OSD manufacturers is to ensure that the facilities meet current regulatory requirements. Since many of the new products are high-potency products, both regulatory requirements and OHS and EHS requirements are quite high for many of the new products.
A new trend is that some biopharmaceutical products may be formulated into OSD products (and not injectables). Importantly, there is a potential synergy between OSD and these next generation biopharmaceuticals: Many of the new biopharmaceutical products contain high potency ingredients requiring appropriate containment solutions, which are new to biopharmaceuticals, but have been used for a number of years in OSD manufacturing.
As a result of the increased focus on cGMP, high product quality, lean manufacturing, reduced time to market and cost reduction, OSD facilities are now in the lead in terms of facility innovation within continuous manufacturing, process analytical technology (PAT) and other areas, with active involvement of the US FDA.