Self Injection Platforms

Have you thought about the complexities of a patient’s journey through treatment? Navigating from leukemia diagnosis to treatment can be a difficult one. Informing family members, managing loved ones’ reactions, weighing the many different treatment options and facing the reality of multiple hospital visits can be overwhelming.

In the biologics space, there are clear trends toward higher delivery volumes, less frequent dosing, and the conversion from intravenous to subcutaneous delivery. This is driving demand for wearable technologies. Read more below about the FDA’s Patient-Focused Drug Development (PFDD) Initiative and how these findings can enable more insightful patient offerings.

In 2018, we saw a record-setting year for new-molecular entity (NME) approvals (59) at the FDA1 versus 46 in 2017. 58% were for orphan drugs (patient population less than 200,000 in the US) with 17 biologic-based NME’s. Biosimilars are gaining traction in Europe, in particular. Major factors that are driving the market growth are next-generation business, high growth in chronic diseases, less expensive biosimilar drugs and favorable government regulations.

At the recent CPhI China Conference, we introduced our Integrated Solutions Program to the Asia Pacific Market. The Program is designed to help reduce risk, mitigate regulatory complexity and Simplify the Journey™ from molecule to market for our pharmaceutical partners.

Before an injectable biologic can be formulated and manufactured, an extensive series of pre-formulation checks are necessary to ensure that developers avoid formulating an unstable, non-viable product¹. Developers must determine whether the injectable biologic will break down within the intended formulation or the manufacturing process. The drug must be thermally stable, possibly resistant to oxidation, tolerate variations in light, and other environmental stresses placed on it during manufacturing and packaging.

Ophthalmic drug products (ODPs) present a special challenge for the measurement of extractables and leachables (E&L) due to the presence of multiple leachables sources.  ODPs typically are packaged in labelled, semipermeable polymer (e.g., low density polyethylene) containers (i.e., primary container) and stored in cardboard containers (i.e., secondary container) along with instructions for use.  The polymer, label, cardboard and paper are all possible sources of leachables.