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Outsourcing partners can provide a multitude of advantages in the development of drug delivery solutions, including those designed for targeted patient populations.
Outsourced services within the bio/pharma industry are growing robustly driven by a variety of factors, such as a greater emphasis on niche patient-populations and rare diseases, a rise in the number of smaller bio/pharma companies, increased market fragmentation, and more demand for patient-centric solutions. According to market research, the contract development and manufacturing organization (CDMO) outsourcing market has the potential to increase by $44.17 billion between 2020 and 2024 (1).
An aspect of drug development that can be facilitated through the use of an outsourcing partner is the development of an effective drug delivery solution. “A good outsourcing partner can provide drug companies with expert guidance into the most effective drug delivery technologies to enable them to successfully commercialise their product,” confirms Arul Balasundaram, formulation manager at Recipharm’s Queensborough facility (United Kingdom). “Such a partner can find the ideal balance between ease of formulation, method development, and subsequent manufacture.”
“In the development of a drug delivery system, there are several benefits that outsourcing offers that can help drug developers gain a competitive advantage,” says Behzad Mahdavi, vice-president open innovation biologics, cell & gene therapy, Catalent. “[Generally], pharma and biotech subject-matter experts are mostly limited to evaluating one method of delivery because of limited time or other resources, or simply because of a narrowness or focused expertise in their own organizations.”
To improve the potential for success in development, having knowledge and the ability to assess multiple enabling technologies in parallel to target different barriers or formulations to reach the target is imperative, Mahdavi continues. “A development partner with multiple technology capabilities can help bring different perspectives and therefore offer advantages over single technology solution providers,” he notes.
For Ralph Landau, head of Development, Drug Product, Cambrex, a good CDMO should be able to offer a wealth of drug delivery expertise. “A CDMO can offer deep support in developing the right formulations, including delivery systems, by balancing previous experiences with innovative problem-solving to decrease complexity and enhance quality,” he says. “The right CDMO works with customers as a partner to transparently fill manpower and knowledge gaps. Regardless of the size or maturity of the company, an outsourced partner offers a multitude of benefits that help to bring safe, effective drug products to the market faster.”
Additionally, advantages can be gained in partnering with an expert for specialist dosage forms, such as topical products for skin, eye, airways, or mucosal membranes, asserts Lynn Allen, vice-president Business Development, MedPharm. “To facilitate optimum formulation development, unique experience and knowledge are required, something that most development companies lack in-house,” she emphasizes. “This is especially the case for specialist topical products as the requirements for delivery are quite different from oral and intravenous routes of administration.”
“Drug delivery is advancing to meet patient needs,” reveals Satish Shetty, director of Product Development, Cambrex. “Instead of a general population approach, there are now defined pediatric and geriatric patient groups via regulatory agencies in the US and Europe. Advances are being made in drug delivery systems to circumvent common conventional dosage limitations, including poor solubility and bioavailability, blood-brain barrier permeation, GI tract degradation, dose-dumping, and so on.”
“Drug delivery solutions that are easy to use and require less frequent administration play a major role to achieve better patient compliance,” adds Maaike Everts, technical marketing leader for parenteral drug delivery, Evonik. An example of a delivery solution that can improve patient compliance is a long-acting injectable, such as bioabsorbable microparticles and implant based on lactide/glycolide polymers, which reduce the frequency of administration, she explains. “These formulations can deliver peptide and small molecule drugs for weeks or months following a single administration, replacing daily injections and daily oral dosing,” Everts says.
Other examples of delivery solutions that can be employed to boost patient compliance and optimize drug performance, include microparticle, nanoparticle, implant, and in-situ forming technologies, Everts continues. “Typically, the goal is to address some combination of formulation challenges that can optimize the release profile, reduce frequency or dose volume, increase bioavailability, avoid toxic side effects, or facilitate more efficacious plasma levels,” she states.
“A lot of attention is being placed on reduced dosing frequency, by modifying potency and release profiles, which increases compliance for all patient populations,” concurs Shetty. “This includes a focus on minimizing the fluctuation of drug concentration and maintenance of blood levels within a desired range.”
Patient compliance is a significant issue in pediatric populations, asserts Andrew Parker, director Open Innovation, Small Molecules, Oral and Specialty Drug Delivery, Catalent. “When developing a pediatric indication of an existing adult formulation, different delivery solutions/formats must be developed to resolve this issue,” he says. “The use of mini-tablets has generated increased interest in recent years because of their ability to be used as sprinkles (as considered by FDA if the mini-tablet is less than 2.5 mm in size), and so can be dosed with food stuffs such as yogurts or porridge. Mini-tablets also provide an attractive solution as potentially being able to easily translate the existing adult format without significant further formulation development.”
Landau highlights the fact that drug developers are taking more time to review other solid dosage forms to determine how the shape and size might impact compliance. “Mini-tablet forms (tablets ≤2 mm in diameter) are helping to increase the acceptability of pediatric drugs and guidance has been drafted by FDA for other solid dosage size and shape requirements,” he adds. “Studies have been carried out to investigate different patient swallowing ability profiles by age, as well as general patient preferences.”
Additionally, Landau notes that there is growth in patient administration of drug therapies for different disease states, such as rheumatoid arthritis, psoriasis, diabetes, chronic pain management, long-term management of asthma, and mental health issues. “With the patient in control of staying on track with treatments, there have been a variety of hurdles to compliance,” he says. “Mechanical complexity, physical dexterity and needle phobias are some of the most common challenges that cause patients to get off track with dosing, which negatively impacts treatments.”
Despite the market dominance of oral solid dosage there are some drugs that cannot be delivered in a conventional way due to instability, and to meet rising patient expectations, pharmaceutical companies are required to make more user-friendly forms for these products too, Allen specifies. “Many patients prefer to use dosage forms that positively impact their health whilst integrating seamlessly into their lifestyles,” she explains. “This is especially important with topical formulations as the cosmetic and aesthetic properties are a critical aspect as patient compliance is often driven by the ease of use and the application experience. Using an outsourcing partner that understands the end-user’s opinion and preferences are crucial from the start to ensure these factors are incorporated into the product profile from the outset of development.”
Employing a drug development specialist outsourcing partner can provide a sponsor company with access to experts with a proven track record in selecting the optimum delivery solution based on the needs of the drug substance in question, asserts Balasundaram. “A good partner will also be able to draw from experience to assess risk at every stage of the process, can advise on overcoming inherent development hurdles and provide the timeliest and most cost-effective solution for projects,” he summarizes. “In doing so, [a good partner] can help enhance the efficiency of the development process and minimize time-to-market making selection absolutely critical to success.”
1. Technavio, “Contract Development and Manufacturing Outsourcing Market by Product and Geography—Forecast and Analysis 2020–2024,” Market Report, April 2020.
Felicity Thomas is the European editor for Pharmaceutical Technology Group.
Supplement: Partnering for Bio/Pharma Success
When referring to this article, please cite it as F. Thomas, “Delivering a Wealth of Experience,” Partnering for Bio/Pharma Success Supplement(February 2021).