Contract manufacturing of biologics poses unique challenges that demand innovative solutions. Most biologics products must be administered as parenterals. However, the liquid form of many biologics are not shelf-stable, requiring them to be formulated as liquids and then lyophilized for storage.
Lyophilized products have longer shelf-lives, but they also require reconstitution, which can be a time-consuming and cumbersome process. Reconstituting parenteral products also introduces increased risk of user error.
One innovation that has reduced the risk of error and increased the efficiency of lyophilized parenteral products is the dual-chamber delivery system, which is now used for delivery of many biologics products.
Dual-chamber delivery simplifies the application of parenteral products produced through biologics contract manufacturing.
Most lyophilized products are delivered in vials. The end user must then measure out an appropriate amount of liquid diluent in a syringe, and apply the diluent to the lyophilized vial. This takes time, careful measurement, and introduces the risk of error.
Once the lyophilized product has been reconstituted, it can then be drawn from the vial into a syringe. The user must then change the needle on the syringe for sterility, before finally administering the product.
Dual-chamber delivery systems cut out many of these steps. Instead of a separate syringe and lyophilized vial, the dual-chamber system features two chambers: one containing the lyophilized product, the other containing the diluent needed to reconstitute the product.
When it is time to administer the parenteral, the diluent travels through a channel between the two chambers and reconstitutes the drug, eliminating the need for measuring on the part of the end user, and reducing the risk of user error. This also eliminates the need to change needles.
Products produced through biologics contract manufacturing benefit from dual-chamber systems in several ways.
Besides being easier to use, parenteral products manufactured in dual-chamber systems also offer increased dosing precision. The product and the diluent are both pre-measured and contained in sealed chambers, eliminating the need to re-measure.
This also cuts down on the risk of medication error. Because only one applicator is being used, there’s no need to switch between vials and needles, which not only reduces the risk of user error, but also reduces risks to the patient associated with multiple potential sources of contamination.
Because they are pre-measured and easy to use, dual chamber systems allow patients to self-administer drugs at home without the risk of making a mistake. Dual-chamber cartridges can even be included in pen systems for multiple-dose medications.
Finally, dual-chamber systems reduce overfill. Lyophilized vials must generally be overfilled in order to ensure that there is enough of the reconstituted product to draw into a syringe for dosing. Since the dual-chamber device is a closed system, however, less overfill is required and more precise dosing is possible.
Biologics contract manufacturing of dual-chamber products poses unique challenges.
Dual-chamber systems are easy to use and require less precision on the part of those administering the parenteral product, but manufacturing biologics in dual-chamber systems is a complex undertaking.
Because the biologic product must be lyophilized within the delivery system, the stages of manufacturing become extremely specific. First, the glass chambers must be washed, siliconized, and sterilized. A sterile middle stopper separates the chambers.
The biologic product is loaded into the front chamber in its liquid form and then lyophilized. Only after the parenteral product has completed lyophilization can the diluent be added to the second chamber.
Because the entire apparatus must go through the lyophilization process, every part of the dual-chamber system must be selected to withstand the extremes of temperature and pressure associated with lyophilization. Also, depending on the type of biologics product being manufactured, some compounds can interact with silicone or rubber, requiring careful selection of components.
Especially for compounds that require precise measurements for reconstitution, dual-chamber systems for the products of biologics contract manufacturing can save time and even lives.
While the contract manufacturing of parenteral biologics into dual-chamber systems may be a little more complex than traditional lyophilization, the benefits—especially to the end user—are often worth it.
As more potent compounds and biopharmaceuticals find wider use, dual-chamber delivery systems for needed drugs can decrease administration time and reduce the risk of dosing mistakes, which can potentially save lives.
However, these vital medical interventions require contract manufacturers who are ready and willing to meet the demands and challenges associated with producing biologics in convenient, safe dual-chamber delivery mechanisms.