The selection of appropriate primary container packaging for an injectable drug product is one of the most fundamental considerations in the drug development process. The wrong choice can cost significant time and resources later in the process and cause regulatory issues
Howard Drake, Vice President of Business Development for leading pharmaceutical glass container producer, Stevanato Group, discusses the key considerations for primary container packaging success.
Careful planning is crucial when selecting a primary container for injectable drug development. Companies must ensure that they make the correct selection of the primary container at the right time in the product development cycle.
If a company simply chooses a container by default and without clear technical rationale, they may hold on to that choice until very late into the drug development cycle before recognising that it is not the container they want to bring to market. The implications of this error can be serious in terms of cost and time … and may even result in the need to reformulate the drug.
A container may not be appropriate for a number of reasons related to both the physical integrity of the drug and the container itself. Drug administration factors to consider include stability and sensitivity, which will affect the type of container that should be used.
Container-specific factors include cosmetic appearance, filling equipment, chemical durability (risk of glass delamination or pH shift) and container closure integrity (CCI). Manufacturability must also be considered to ensure compatibility across all these parameters and thorough testing is key to address this.
Long-term lifecycle management is also a consideration. For example, if a drug is initially introduced in vial format, it may then eventually be converted into a different container — such as a prefillable syringe — owing to market preferences.
All of these considerations can be mitigated by a proper risk assessment in early product development. For many companies, it is beneficial to work with a glass primary packaging partner who can provide guidance and risk analysis both for the short-term and eventual long-term lifecycle management.
With a thorough risk analysis strategy early on, companies can minimise risks and remove some elements of uncertainty, helping to save money and time.
Also fundamental when considering primary packaging requirements is ensuring that a container meets global regulatory requirements. Pending regulatory changes need to be addressed to make sure the container system meets future requirements.
In the past, some companies had to recall their pharmaceuticals when reflective flakes consistent with delamination of the glass vial were found. As regulatory bodies are advising pharma companies and issuing guidelines, it’s important to use expert third-party advice when necessary.
The shift of administration from the skilled care environment of a hospital or a clinic to home healthcare is now also front of mind when selecting a primary packaging system. Medications for some chronic diseases (rheumatoid arthritis and hypercholesterolaemia, for instance) and a wide variety of biological preparations are being developed so they can be administered by either the patient themselves or a home healthcare worker.
Although this helps to drive down the cost of implementation of these drugs, it forces drug companies to make clear choices regarding the primary container. In the past, systems may have evolved from a vial to an autoinjector with time. However, drugs are now being developed directly into prefillable syringes to meet the increasing homecare demand and to cut further costs out of the healthcare system.
The economic value of time-to-market can never be underestimated. Not having the correct packaging in place can lead to significant delays. A 6-month delay, depending on the programme, can cost a drug company time, money and lost opportunity. Even a one-month delay can cost several million dollars.
To help avoid unnecessary delays, it’s important that drug developers work with a specialist partner who is able to guide them on one of the most critical decisions in their drug development programme: choosing the right primary container that supports requirements from early stage formulations through to future integration into delivery devices.