The pharmaceutical industry has experienced an unprecedented shift over the past five years with the growth of biologics outpacing that of small molecule drugs.1 Complex biologics have brought innovative new treatment options to patients with many chronic illnesses, including rheumatoid arthritis, Crohn’s disease, and certain cancers.
Industry analysts predict that biologics will continue to experience rapid and transformative growth as more drug manufacturers tap into their potential; the QuintilesIMS Institute forecasts that spending on biologic treatments for autoimmune diseases will reach $75-90 billion in 2021.2
This steady rise in new biologics also is spurring innovation in drug delivery systems. Biologics are sophisticated therapies that often have very specialized containment needs. Many injectable biologics require higher concentrations for an effective dose, leading to more viscous drugs and/or greater dose volumes than small molecule drugs.
Additionally, some biologics can be sensitive to certain materials used in injectable drug packaging and delivery systems, such as silicone oil or tungsten, presenting concerns around possible interactions between biologics and their container/closure system. These issues are driving the need for integrated packaging and delivery systems that minimize the adverse impact on injectable biologics.
When creating delivery systems for biologics, there are a few top considerations that manufacturers should keep in mind:
1. Product Lifecycle: It is essential that combination products (incorporating both the biologic and its delivery system) be designed to be manufactured efficiently over the product lifecycle, from product development through to commercialization. This entails a deep understanding of several factors: the various components of the delivery system; the equipment, molds, and materials used in its design and development; and, most importantly, how patients will use the delivery system.
Human factors analysis can be key to verifying and assessing the readiness of a delivery system to be put in the hands of patients. This research also can help identify issues that may not be obvious during the design verification stage. For example, patients with dexterity issues or vision impairment may have difficulty administering their treatment. It is critical to take whatever learnings arise from human factors analysis and apply them to improving the drug delivery platform.
2. Scale-up Capabilities: When launching a new biologic combination product, the drug manufacturer may opt to start by producing a low volume to validate production processes prior to scaling up fully automated lines.
To help identify and rectify any potential issues, the contract manufacturing partner should thoroughly assess every aspect of on-site assets—including tooling, equipment, facilities, and cleanrooms—to ensure scale-up demand can be met. Additionally, the biopharmaceutical company will want to understand their delivery system manufacturer’s supply chain from top to bottom, to ensure operations can keep up with capacity and avoid any security of supply risk.
By fine-tuning scale-up abilities, drug delivery technology providers position themselves to accommodate the wide-ranging needs of pharmaceutical companies in the short term and create a long-lasting partnership in the long term.
3. Quality Regulations: For a combination product to go to market, it must meet a number of regulatory approvals, especially if launched globally. To ensure products are safe for patients, regulatory agencies are placing high expectations on drug manufacturers and their suppliers to build quality processes in manufacturing from the start.
Additionally, new regulations are consistently being written for new drug products, often after development is under way. It is important for delivery system manufacturers to implement and refine Quality by Design processes and to have a working relationship with regulators to keep on top of changes and adjust process scale-up accordingly.
4. Temperature: Injectable biologics often require low-temperature storage in order to maintain the stability and integrity of the drug product. This presents significant challenges for drug delivery systems. Cold chain products need to be packed in such a way that the required temperatures are maintained throughout the journey. Any deviation from the ideal environment can jeopardize the drug’s quality, resulting in loss of potency, efficacy, or even the need to discard the product entirely.
It is important for contract manufacturers of combination products to consider and address temperature concerns throughout the supply chain to ensure proper handling, storage, transportation, and dispensing to minimize risk to the patient and the drug.
5. Innovation: Biopharmaceutical companies are relying on contract manufacturers of drug delivery systems to continuously innovate. Wearable drug delivery technology is a good example of how manufacturers are staying ahead of the curve. New wearable drug delivery platforms that are electronically connected to smartphone applications are making it easy for patients to track dosage history and for healthcare providers to track patient adherence to prescribed treatment regimens.
This data can help clinicians better understand where patients are in their journey so that they can offer the most complete care. Bringing these connected health injectors to life requires a team of creative thinkers and technology innovators. Having scientists, software developers, and engineers collaborate in the design and development process for a new combination product can be key to adopting future technologies that may help improve patient outcomes.
Relying on Partners
The rise in biologics presents a wealth of opportunities for patients while simultaneously spurring new challenges for biopharmaceutical companies and their suppliers. It is critical that these complex and often time- and resource-intensive drug products ultimately provide value for patients, providers, and payers. Innovative delivery systems can be critical to ensuring the success of a new injectable biologic and creating return on investment.
More and more, biopharmaceutical companies —which often have few resources to take delivery system manufacturing in-house—are relying on their contract manufacturing partners to help them stand out in an increasingly crowded market. To be successful, contract manufacturers must deliver continuous innovation and flexibility that can accommodate the delivery of a biologic throughout its lifecycle.
By carefully considering the needs of the biologic and patients, and instituting efficient and innovative processes, contract manufacturers can play a critical role in bringing these important medicines to patients safely and effectively.
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References:
1 QuintilesIMS Institute. Disruption and maturity: The next phase of biologics. 2017.
2 QuintilesIMS Institute. Outlook for Global Medicines through 2021: Balancing Cost and Value. December 2016.
About the Author
Mike Treadaway is Vice President and General Manager of Contract Manufacturing at West Pharmaceutical Services, Inc.
This story also can be found in the April/May 2018 issue of Pharmaceutical Processing.
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Filed Under: Drug Discovery
