Every small detail is essential for your next big breakthrough in biologics. Discover the difference of optimizing key components

Is your existing drug delivery system designed to help de-risk your next combination product?

Every small detail can make a big difference when developing biologics.

Not having an integrated sourcing and manufacturing process can cause challenges at every stage of developing combination products for complex biologics. These challenges may result in performance issues such as*:

Injection not starting

Injection delivering incomplete doses

High variations in injection time and depth

Prefillable syringe breaks during assembly or injection

Container closure integrity (CCI) failures, leading to contamination, drug leaks or sterility breaches

Any of these issues may disrupt your new biologic drug, potentially resulting in:

Increased operating costs

Disrupted production

Delayed release

Jeopardy to patient health

Drug recalls¹

Measuring needles

Even small changes in the needle you use can make a big difference to the injection experience

Studies show that the standard 12.7 mm needle may not be optimal for subcutaneous drug delivery.² Consider how your current choice of needle length and needle inner diameter influence factors such as injection force and injection time for a given solution viscosity.²

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Increased risk of accidental intramuscular (IM) injections with 12.7 mm needles when compared to 8 mm needles²

To expand biopharmaceutical design spaces, drug delivery systems should accomodate higher volumes and viscosities

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12.7 mm needles may require more injection force and time compared to 8 mm needle-length syringes, which can pose a problem to patient experience^2,3

Measuring a vial

Ensuring compliance and compatibility are more critical than ever to evolve biologics

Emerging biologic drugs typically have more sensitive, viscous and complex structures, which can affect gliding performance and drug-container compatibility.⁴ Multiple industry bodies and public health organizations have also issued guidelines to enable safe and continued treatment to patients:

Zero tolerance on defects related to visible particles

– PDA, PMF, European Pharmacopoeia Commission^5,6

Health authorities urging for more resilient supply chains

– FDA, USP, EMA

Post-approval studies, and submit progress reports every 180 days

– FDA⁷

Male doctor smiling at male patient

Developing new biologics is complex. But choosing the right partner is not.

BD Medical – Pharmaceutical Systems is a global leader in prefillable parenteral drug delivery systems. And we’re always proactively evolving our solutions and services to address your emerging biologics needs such as quality, reliability, compatibility and continuity of supply.

Why choose BD Medical – Pharmaceutical Systems as your end-to-end partner

Quality

Supply

Documentation

Compatibility

50+ years collaborating with biopharma companies like yours to innovate combination products

Now partner with 500+ pharma and biotech companies, including 26 of the world’s top 30 pharma companies^8,9

Manufacturing 3B+ prefillable syringe containers each year¹⁰, and 18B+ PFS plunger stoppers sold since 2015¹¹

30+ drugs have been approved in a BD Neopak™ Glass Prefillable Syringe¹²

BD offers an integrated PFS system approach, backed by a comprehensive portfolio of syringes, stoppers and other drug delivery solutions

Introducing our advanced Biologics Prefillable Syringe Platform

Featuring the

The BD Neopak™ Glass Prefillable Syringe Platform was designed to meet the evolving needs of biologics with our advanced platform technologies. Choose the combination of solutions that best meet your range of requirements, such as viscosity, drug-container compatibility, and device integration. Consider our single PFS platform approach, with minimal SKUs, and little to no change in core materials, such as glass, silicone and rubber.

Look closer at how we can help you advance biologics at each step…

Optimize delivery of viscous drug formulations and improve patient experience

The BD Neopak™ XtraFlow™ Glass Prefillable Syringe combines an 8 mm needle length with thinner wall technology, enabling you to optimize injection performance for high-viscosity and/or high-volume therapies, positively impacting patients’ self-injection experience^3,23

Choose from two needle technologies

Up to 46%

reduction in injection force^‡3

Up to 57%

less injection time^‡3

2.5x to 8x

lower risk of IM injections^μ23,24

Reduce

needle-related anxiety in patients^µ23

Positively impact preference

for self-injecting patients with chronic diseases^µ23

Lets help you de-risk end-to-end and deliver your next combination product

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Get contacted by a BD sales rep

* Based on BD’s experience working with customers.
# When compared to the BD SCF™ FluroTec® ∞ Plunger Stopper.
** Results based on a sample of 100 pieces of BD Flurotec® and BD SCF™ PremiumCoat®. Variables compared were Mean (glide force reduction) and standard deviation (glide force variability).
^ Injection time is defined as the time required from the start of the injection (start of stopper translation) to the time required to empty the reservoir or prefillable syringe. Injection time was measured in air with a PEG (polyethylene glycol) filled syringe. Injection time variability refers to consistency of results (or reduced dispersion) for injection time with the BD SCF™ PremiumCoat® Plunger Stopper, BD Neopak™ Glass Prefillable Syringe and 2-steps BD Disposable Autoinjector compared to Flurotec® 1mlL. Injection time was measured in air through benchtop testing with the BD SCF™ PremiumCoat® Plunger Stopper, BD Neopak™ Glass Prefillable Syringe and 2-steps BD Disposable Autoinjector.
^^ No “Ribs not touching after irradiation” criteria in the PremiumCoat® customer specification: Becton Dickinson and Company. BD SCF™ PremiumCoat® Plunger Stopper 1-3mL Customer quality specification; Results based on a sample of 100 pieces of BD Flurotec® and BD SCF™ PremiumCoat®.
† Extractables analysis with glass cane and by immersion showed that the coating provides a barrier effect for a number of potential extractables in the 6720 formulation, for elemental impurities and semi-volatile and non-volatile organic molecules. Alternative stopper tested is FluroTec® 1mlL.
‡ For a 30cP solution. With BD Neopak™ XtraFlow™ 27G 8mm ultra-thin wall syringe when compared to a 12.7mm 27G special thin-wall syringe. Ejection force and injection time values were simulated through a mathematical model based on the Hagen-Poiseulle equation. For injection time reduction, a constant force was defined. For injection force reduction, a fixed time was defined.
µ With BD Neopak™ XtraFlow™ 27G 8mm ultra-thin wall syringe when compared to a 12.7mm 27G special thin-wall syringe.

PDA: Parenteral Drug Association; PMF: Public Master File; FDA: U.S. Food & Drug Administration; USP: U.S. Pharmacopoeia; EMA: European Medicines Agency; PFS: Prefillable Syringes; ETFE: Ethylene tetrafluoroethylene.

References:

1. Food and Drug Administration. 2024 Recalls. FDA website. Accessed on April 2, 2024, at https://datadashboard.fda.gov/ora/cd/recalls.htm.
2. Pager A, Duinat B, Alves B. How Shorter Needles with Thinner Walls are Set to Improve the Injection Experience in Chronic Care. ONdrugDelivery Magazine. 2020; 107: 37-42. https://ondrugdelivery.com/how-shorter-needles-with-thinner-walls-are-set-to-improve-the-injection-experience-in-chronic-care/
3. Injection time and ejection force calculation [internal study], Le Pont-de-Claix, France; Becton, Dickinson and Company; 2021.
4. 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
5. GMP-Compliance. 2018 European Pharmacopoeia: New Chapter on Visual Inspection for Visible Particles. GMP Compliance website. https://www.gmp-compliance.org/gmp-news/european-pharmacopoeia-new-chapter-on-visual-inspection-for-visible-particles. Accessed April 2, 2024.
6. Johns J, Golfetto P, Bush T, et al. Achieving “Zero” Defects for Visible Particles in Injectables. PDA J Pharm Sci Technol. 2018;72(6):640-650. doi:10.5731/pdajpst.2018.009027
7. U.S. Food and Drug Administration. 2024 SOPP 8415: Procedures for Developing Post marketing Requirements and Commitments. FDA website. Accessed on April 18, 2024, at https://www.fda.gov/media/90591/download.
8. BDM-PS Financial file November 2020, “Actual FY20” Perimeter.
9. BD Customers compared to Evaluate Pharma ranking FY2019.
10. BDM-PS supply chain demand (BDMPS Supply Chain demand file_Desy 2018-2023), August 2021.
11. BDM-PS sales analysis [internal analysis]. Pont-de-Claix, FR: Becton, Dickinson and Company; 2020.
12. Registration status of drugs in BD Neopak™ Glass Prefillable Syringe, May 31st, 2024 [Internal regulatory report]. Pont-de-Claix, FR: Becton Dickinson and Company; 2024.
13. Design Control Evidence BD SCF PremiumCoat 1-3mL Plunger Stopper.
14. Becton, Dickinson and Company. Bausch + Ströbel SCF PremiumCoat® Plunger Stopper: Proof of processability. BD Medical – Pharmaceutical Systems; 2020 V-630076 2020.
15. Becton, Dickinson and Company. DVTR20234262_DV data BD SCF PremiumCoat® 1-3 mL R&D data [internal study]. Le Pont-de-Claix, France; Becton, Dickinson and Company; 2023.
16. Becton, Dickinson and Company. TR20234488 Le Pont-de-Claix, France; Becton, Dickinson and Company; 2024.
17. Becton, Dickinson and Company. DVTR20192507_DV data BD SCF PremiumCoat® 1 mlL R&D data [internal study]. Le Pont-de-Claix, France; Becton, Dickinson and Company; 2023.
18. Becton, Dickinson and Company. TR20233592 – Extractables data on BD PremiumCoat® 1-3 mL coated and non-coated Stoppers.
19. BD SCF™ PremiumCoat® Plunger Stopper 1-3mL Customer Quality Specification; 2023.
20. Becton, Dickinson and Company. Prefilled Syringe Customer Requirements Research, Voice of the Customer [internal study]. Le Pont-de-Claix, France; Becton, Dickinson and Company; 2018.
21. Becton, Dickinson and Company. BD SCF™ PremiumCoat® 1mlL Plunger stopper simulated extractable and leachable study [internal study]. Pont-de-Claix, FR: Becton Dickinson and Company; 2019.
22. BD Neopak™ XtraFlow™ 2.25 mL prototype evaluation [internal study] , Le Pont-de-Claix, France; Becton, Dickinson and Company, 2020.
23. Pager A, Combedazou A, Guerrero K, et al. User experience for manual injection of 2 mL viscous solutions is enhanced by a new prefillable syringe with a staked 8 mm ultra-thin wall needle. Expert Opin Drug Deliv. 2020;17(10):1485-1498. doi:10.1080/17425247.2020.1796630
24. Gibney MA, Arce CH, Byron KJ, Hirsch LJ. Skin and subcutaneous adipose layer thickness in adults with diabetes at sites used for insulin injections: implications for needle length recommendations. Curr Med Res Opin. 2010;26(6):1519-1530. doi:10.1185/03007995.2010.481203