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Clinical evaluation of large volume subcutaneous injection tissue effects, pain and acceptability in healthy adults
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In this webinar we have:
- Point 1
- Point 2
- Point 3
Overcoming challenges in drug delivery
As the patient population for key chronic conditions treated with injectables steadily grows, there is an increasing trend toward home care and self-injection of medication for the management of these diseases.
But the development of a combination product for chronic disease treatment can come with many challenges.
Primary and secondary device identification1
Drug compatibility2
Operational feasibility3
Performance and integration feasibility3
Regulatory registration4,5
Intellectual property challenges4,6
These challenges can cause delays, which then lead to increased costs that can negatively impact profitability3 and decrease the overall viability of the project.
Increased complexities introduce new challenges
The high dosing complexity (e.g., increasing viscosity and volume) associated with subcutaneous biologic delivery is pushing the boundaries of traditional combination product design.
Introducing even more potential challenges and trade-offs during combination product development9:
- Pharmacokinetic bridging
- Dosing and treatment regimen
- Concentration and solubility
- Patient acceptance and usability
- Spring force
- Mechanical considerations
- Usability
- Device maturity and availability
Examples of combination product development options
Simplify complexities with BD system integration
From early stage system validation and design verification testing to anticipating and mitigating risk throughout the entire development process, BD integrated systems offer solutions to the complexities of combination products at each stage.
Glide force testing supports appropriate primary container selection
Statistical tolerance analysis supports reliable system performance over time
Injection time modeling helps improve insights into repeatable device performance
Early stage system validation and design verification testing
Quality commitment at both component and system level
Human factors engineering testing across broad range of users
Aims to enable significant time and cost savings
Comprehensive support in a complex regulatory environment
- Glide force testing supports appropriate primary container selection
- Statistical tolerance analysis supports reliable system performance over time
- Injection time modeling helps improve insights into repeatable device performance
- Early stage system validation and design verification testing
- Quality commitment at both component and system level
- Human factors engineering testing across broad range of users
- Designed to enable significant time and cost savings
- Comprehensive support in a complex regulatory environment
Read more about the value of BD integrated systems for combination products.
Download article
Download article
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Increased complexities introduce new challenges
The high dosing complexity (e.g., increasing viscosity and volume) associated with chronic subcutaneous drug delivery is pushing the boundaries of traditional combination product design.
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Pellentesque habitant morbi tristique senectus et netus et malesuada fames ac turpis egestas vestibulum tortor quam.
As the patient population for key chronic conditions treated with injectables steadily grows, there is an increasing trend toward home care and self-injection of medication for the management of these diseases. But the development of a combination product for chronic disease treatment can come with many challenges. 23983_DrugCompatibility_120px.png Primary and secondary device identification1,2 23983_DrugCompatibility_120px.png Drug compatibility3 23983_DrugCompatibility_120px.png Operational feasibility4 23983_DrugCompatibility_120px.png Performance and integration feasibility4 23983_DrugCompatibility_120px.png Regulatory registration5,6 23983_DrugCompatibility_120px.png Intellectual property challenges2,5,7 These challenges can cause delays, which then lead to increased costs that can negatively impact profitability4 and decrease the overall viability of the project.4
Due to its high viscosity, injecting hyaluronic acid puts a lot of pressure on a syringe. That’s why hyaluronic acid manufacturers prioritize needle connection and LLA rotation issues that cause leakage.3 Our BD Hylok™ Syringe has:
- A robust LLA design that reduces the risk of rotation1,2, allowing users to tightly screw on the needle.
- A demonstrated record of excellent performance after terminal steam sterilization over time.1+
Discover more about our BD Hylok™ Syringe and our entire family of injectable delivery systems >
+ terminal steam sterilization at 121°C / 2 cycles / 20min
Due to its high viscosity, injecting hyaluronic acid puts a lot of pressure on a syringe. That’s why hyaluronic acid manufacturers prioritize needle connection and LLA rotation issues that cause leakage.3 Our BD Hylok™ Syringe has:
- A robust LLA design that reduces the risk of rotation1,2, allowing users to tightly screw on the needle.
- A demonstrated record of excellent performance after terminal steam sterilization over time.1+
Discover more
about our BD Hylok™ Syringe and our entire family of injectable
delivery systems >
+
terminal steam sterilization at 121°C / 2 cycles / 20min
360° rotation knob is effectively sized, contoured and located to enable easy instrument rotation.
360° rotation knob is effectively sized
360° rotation knob is effectively sized
360° rotation knob is effectively sized
Engineered for superior performance with hyaluronic acid
Did you know that 72% of decision makers prefer glass syringes over plastic? Explore the benefits of the BD Hylok™ Glass Syringe and other unique features.3
BD Hylok™ Glass Prefillable Syringe for hyaluronic acid
Screw on tip cap
Easy to use and intuitive tip cap with
proven user preference2
New bonding technology
Reduced risk of LLA
disconnection/rotation1,2
New LLA thread design
Safe and robust needle
connection4
Glass barrel
Limited risks and costs associated with
potential container change
Testimonials
See how devices like our BD Hylok™ Syringe are changing the way dermatologists look at glass syringe performance
Choosing the right delivery solutions partner for your combination drug development and commercialization can help de-risk the development process, minimize development tradeoffs and reduce challenges from research to commercialization.
Partnership that performs at each stage
At BD, we strategically develop solutions to anticipate challenges and mitigate risks at each stage of the biologic combination product development process. These solutions combine with our broad experience and deep expertise to help your drug get to market efficiently and safely.
Partnering with BD in combination drug development and commercialization can:
- Help de-risk the development process
- Help improve system integration
- Help reduce obstacles that result in a delayed time to market
- Support WW registrations and regulatory strategies
- Increase flexibility to meet patients’ needs*
- Help reduce the total cost of ownership
*Increased flexibility through the BD PartnerPathTM Program, which offers access to low quantities of product
Benefits of the BD PartnerPathTM Program:
Access
to the BD integrated drug delivery solution portfolio
Flexibility
to acquire small quantities for early stage development activities
Transparency
of technical documentation and drawings
Learn more about the BD PartnerPath Program.
Request a quote
Benefits of the BD PartnerPathTM Program:
Support
in development activities and regulatory registration
Partnership
in choosing solutions that support your drug’s goals.
Explore our products
BD UltraSafe Plus™
Passive Needle Guard
BD UltraSafe Passive™
Needle Guard
BD Hypak™ for Glass
Prefillable Syringe
BD Neopak™ XtraFlow™
Glass Prefillable Syringe
BD Libertas™
Wearable Injector
BD Neopak™ XtraFlow™ is a product in development; some statements are forward looking and subject to a variety of risks and uncertainties.
BD Libertas™ Wearable Injector is a product in development; some statements are forwarding looking and are subject to a variety of risks and uncertainties. BD Libertas™ Wearable Injector is a device component intended for drug-device combination products and not subject to FDA 510(k) clearance or separate EU CE mark certification.
Challenges of combination product development
To bring a drug-device combination product to market, pharmaceutical companies must select and assemble multiple components that work together optimally to deliver the drug formulation safely and effectively.
But during the development process, formulation and product needs can compete, challenges can arise and tradeoffs may be required.
Choosing the right manufacturing partner for your combination drug development and commercialization can help minimize tradeoff impact, derisk the process and reduce challenges from research to delivery.
Partnership that performs at every step
At BD, we strategically develop solutions to anticipate challenges and mitigate risks at every stage of the chronic disease combination product development process. These solutions combine with our broad experience and deep expertise to help your drug get to market efficiently and safely.
Partnering with BD in combination drug development and commercialization can:
- Help de-risk the development process
- Help improve system integration
- Help reduce obstacles that result in a delayed time to market
- Support WW registrations and regulatory strategies
- Increase flexibility to meet patients’ needs
- Help reduce the total cost of ownership
Simplifying complexities with BD system integration
From early stage system validation and design verification testing to anticipating and mitigating risk throughout the entire development process, BD integrated systems offer solutions to the complexities of combination products at every stage.
Glide force testing ensures appropriate primary container selection
Statistical tolerance analysis minimizes system failure risk
Injection time modeling improves overall device performance
Early stage system validation and design verification testing
Quality commitment at both component and system level
Human factors engineering testing across broad range of users
Designed to facilitate significant time and cost savings
Comprehensive support in a complex regulatory environment
Read more about the value of BD integrated systems for combination products.
Download article
Increased complexities introduce new challenges
The high dosing complexity (e.g., increasing viscosity and volume) associated with chronic subcutaneous drug delivery is pushing the boundaries of traditional combination product design.
Introducing even more potential challenges and trade-offs during combination product development3,8:
- Pharmacokinetic bridging
- Dosing and dose frequency
- Concentration and solubility
- Patient acceptance and usability
- Spring force
- Mechanical considerations
- Usability
- Device maturity and availability
BD PartnerPath™ Program
The BD PartnerPathTM Program provides access to low quantities of individual products and preconfigured delivery solutions, along with supporting documentation and the expertise needed to help get your drug to market as quickly as possible.
Benefits of the BD PartnerPathTM Program:
Access
to the BD integrated drug deliver solution portfolio
Flexibility
to acquire small quantities for early stage development activities
Transparency
of technical documentation and drawings
Support
in development activities and regulatory registration
Partnership
in choosing solutions that support your drug’s goals.
Learn more about the BD PartnerPath Program.
Request download
Increased complexities introduce new challenges
The high dosing complexity (e.g., increasing viscosity and volume) associated with chronic subcutaneous drug delivery is pushing the boundaries of traditional combination product design.
Introducing even more potential challenges and trade-offs during combination product development3,8:
- Pharmacokinetic bridging
- Dosing and dose frequency
- Concentration and solubility
- Patient acceptance and usability
- Spring force
- Mechanical considerations
- Usability
- Device maturity and availability
Increased complexities introduce new challenges
The high dosing complexity (e.g., increasing viscosity and volume) associated with chronic subcutaneous drug delivery is pushing the boundaries of traditional combination product design.
Introducing even more potential challenges and trade-offs during combination product development3,8:
- Pharmacokinetic bridging
- Dosing and dose frequency
- Concentration and solubility
- Patient acceptance and usability
- Spring force
- Mechanical considerations
- Usability
- Device maturity and availability
REFERENCES
- Van den Bemt BJF, Gettings L, Domańska B, Bruggraber R, Mountian I, Kristensen LE. A portfolio of biologic self-injection devices in rheumatology: how patient involvement in device design can improve treatment experience. Drug Deliv. 2019;26(1):384‐392.
- Li Z, Easton R. Practical considerations in clinical strategy to support the development of injectable drug-device combination products for biologics. MAbs. 2018;10(1):18-33.
- Source: “Challenges with System Integration" [external study], Franklin Lakes, NJ, USA: GLG 2019 Double blinded qualitative market research with 8 industry experts. Participants worked directly on drug development projects, requiring combination devices (primary and secondary containers) and included the assembly of PFS and/or PFS with autoinjectors.
- Pourkavoos, N. Unique risks, benefits, and challenges of developing drug-drug combination products in a pharmaceutical industrial setting. Comb Prod Ther. 2,2(2012).
- ISO. ISO 11608-1 Needle-based injection systems for medical use—Requirements and test methods. Accessed December 1, 2020, at https://www.iso.org/standard/65021.html.
- Blackstone EA, Joseph PF. The economics of biosimilars. Am Health Drug Benefits. 2013;6(8):469‐478.
- Wright JM, Jones GB. Developing the subcutaneous drug delivery route. Medical Research Archives. 2017:5(12). doi:10.18103/mra.v5i12.1652
- Cilurzo F, Selmin F, Minghetti P, et al. Injectability evaluation: an open issue [published correction appears in AAPS PharmSciTech. 2016 Dec;17 (6):1508]. AAPS PharmSciTech. 2011;12(2):604-609. doi:10.1208/s12249-011-9625-y
- Bittner B, Richter W, Schmidt J. Subcutaneous administration of biotherapeutics: An overview of current challenges and opportunities. BioDrugs. 2018;32(5):425-440. doi:10.1007/s40259-018-0295-0
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