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Standing front and foremost in biologic drug formulation is the optimization of safety and efficacy while ensuring quality and stability during manufacturing. Biologic manufacturing subjects the formulation to different stresses and conditions that may compromise quality and stability. Recently, the requirement for the development of subcutaneous formulations for high dose drugs, such as monoclonal antibodies, at high protein concentrations has created additional challenges, including degradation.
Recent formulations have been designed to minimize protein aggregation and decrease viscosity, which has led to successful manufacture of many biologics. Current challenges focus on dealing with the high drug volumes and increased concentration, which get pushed upstream to the drug formulators. The panacea of successful drug formulation would be: liquid stable, <1mL, viscosity of <10cP and an injection time of <15 seconds. These product attributes also need to consider the patient as lack of patient compliance will override any novel development the drug formulators make.
The patient experience can be improved using formulation and delivery device technologies. Impact to the patient experience can be improved by:
Formulating drugs that can be self-administered by the patient have progressed the treatment and compliance of disease states such as rheumatoid arthritis and diabetes, with the fundamental shift being driven by a sub-cutaneous delivery rather than IV or infusion. This move to sub-cutaneous delivery is challenging for formulators: how do you balance the pharmacological needs of the drug with the tolerability of the patient?
There are concerns around the subcutaneous space and its ability to tolerate rapid injection and larger dose volumes. Tissue disruption and site reaction may occur and, if the injection is rapid and the volume too large, there is potential for the product to leak back from the injection site, reducing the bioavailability.
As therapeutic dose volumes increase into the 2-10mL space, wearable drug delivery devices play a crucial part in the solution. A wearable device allows longer dosing times, without negatively impacting patient comfort and convenience, and even allows for home administration. The options provided by wearable technology offers new alternatives that were not previously possible due to historically binding parameters for formulators.
West offers the SmartDose® platform of drug delivery devices to meet a variety of wearable, subcutaneous delivery needs. Click here to learn more about how the platform can enable delivery of your drug product.
SmartDose® is a registered trademark of West Pharma. Services IL, Ltd., a subsidiary of West Pharmaceutical Services, Inc., in the United States and other jurisdictions
<span>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.</span>
The recent growth of self-administration devices has provided the opportunity to truly change the landscape in drug delivery. These devices, such as auto-injectors, not only allow for more patient convenience, but also enable different dosing regimens and types of therapies that can now be injected via auto-injector. These advantages are why the auto-injector segment is the fastest growing delivery segment, and the majority of top selling drugs are delivered via PFS/auto-injector.
<p style="margin: 0in 0in 0pt;"><span>West is pleased to announce new extensions of the SmartDose® drug delivery platform, including several new wearable injectors that allow for up to 10 mL of volume to be injected in easy-to-use, wearable formats. The new devices were showcased at the annual PDA Universe of Pre-filled Syringes and Injection Devices conference in Vienna, Austria, in November. </span></p>
The impact of a cancer diagnosis can be stressful. Questions such as “how will I tell my family?”, “how will I afford to pay my bills?”, “will I ever work again?” and even “will I survive?” <span>are at the forefront of the patient’s mind as they process their diagnosis and begin treatment</span>. So, how can the patient experience with treatment be supported? By offering the best quality of care.
Biologic drug products are not new – their development began decades ago; the first monoclonal antibody was commercialized in 1986.<sup> [1]</sup> With the increasing availability of genetic information, and better understanding of subcellular cascades and disease processes, the number of biologic drug products available has increased substantially in response to an exponential growth in targets. <sup>[2]</sup>
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