Services
Services
Primary Packaging Assessment
Primary Packaging Assessment
Ensure your formulation works with the final container right from the start.
Ensure your formulation works with the final container right from the start
Why primary packaging matters
Why primary packaging matters
Primary packaging represents far more than a simple container system - it functions as an integral component of the drug product that can directly influence stability, efficacy, usability, and patient safety throughout the product lifecycle. The complex interactions between formulation components and packaging materials including vials, syringes, stoppers, and closure systems can significantly affect product performance during storage, transportation, and administration phases. For sterile injectable products, selecting and validating appropriate primary packaging early in development is essential to ensure chemical compatibility and minimize extractables/leachables risks, maintain functional integrity across diverse storage and transport conditions, ensure compatibility with fill-finish processes and delivery devices, and meet regulatory requirements for container-closure system qualification. Packaging-related issues, when identified late in development, can cause significant delays in clinical trials, require expensive formulation modifications, substantially increase overall development costs, and potentially compromise product quality or patient safety.
Primary packaging represents far more than a simple container system - it functions as an integral component of the drug product that can directly influence stability, efficacy, usability, and patient safety throughout the product lifecycle. The complex interactions between formulation components and packaging materials including vials, syringes, stoppers, and closure systems can significantly affect product performance during storage, transportation, and administration phases. For sterile injectable products, selecting and validating appropriate primary packaging early in development is essential to ensure chemical compatibility and minimize extractables/leachables risks, maintain functional integrity across diverse storage and transport conditions, ensure compatibility with fill-finish processes and delivery devices, and meet regulatory requirements for container-closure system qualification. Packaging-related issues, when identified late in development, can cause significant delays in clinical trials, require expensive formulation modifications, substantially increase overall development costs, and potentially compromise product quality or patient safety.
Partner with Leukocare for tailored, data‑driven solutions that bring your biologics closer to patients.
Let’s Build the Right Formulation — Together
Let’s Build the Right Formulation — Together
Partner with Leukocare for tailored, data‑driven solutions that bring your biologics closer to patients.
Let’s Build the Right Formulation — Together
What you get
Our primary packaging assessment provides evaluation that prevents compatibility issues and support system selection early in development matching the formulation
Our approach provides a consolidated readout that is practical,
actionable and designed to accelerate decision-making.
Instead of generic risk notes, you receive outputs that can directly inform
experimental design, development priorities and clinical planning:
text for spacing
Let’s Build the Right Formulation — Together
Partner with Leukocare for tailored, data‑driven solutions that bring your biologics closer to patients.
Let’s Build the Right Formulation — Together
Partner with Leukocare for tailored, data‑driven solutions that bring your biologics closer to patients.
text for spacing
How it works - integrated methodology
Select and Evaluate Container Systems - We systematically select and evaluate primary packaging systems for liquid, frozen, and lyophilized formulations, preventing compatibility issues from emerging during later development stages through comprehensive early-stage assessment and validation.
Related capability: Formulation Development and Optimization
Provide Recommendations for Primary Packaging Systems - In collaboration with your chosen CMO and his primary packaging capabilities, we deliver practical recommendations for primary packaging and closure systems that are compatible with manufacturing processes, fill-finish operations, quality control requirements, and regulatory expectations while optimizing cost-effectiveness.
Related capability: Non-GMP Processing & Small-Scale Manufacturing and Particle Characterization
Specialized Testing Capabilities
Specialized Testing
Capabilities
Who it`s ideal for?
This service is especially valuable for teams developing sterile injectable products requiring optimal primary packaging selection and comprehensive compatibility evaluation to ensure product quality and regulatory compliance throughout development and commercialization.
It applies across vials, prefilled syringes, cartridges, and specialized delivery systems for liquid, frozen, and lyophilized presentations, with expertise in complex biologics, high-concentration formulations, and specialized administration requirements.
Whether you're selecting container-closure systems early in development, evaluating device compatibility for patient administration, preparing regulatory submissions, or troubleshooting packaging-related issues, our assessment ensures optimal product protection and performance.
Why partner with Leukocare?
Leukocare integrates primary packaging compatibility testing seamlessly into preformulation, formulation development, and process development workflows with systematic studies that assess the impact of container-closure systems on stability, usability, and handling characteristics beginning in early development phases when changes are still feasible and cost-effective.
We evaluate packaging configurations relevant to diverse product presentations including vials, prefilled syringes, and cartridge systems for liquid, frozen, and lyophilized formulations. Our testing capabilities extend to specialized clinical in-use studies that simulate real-world handling and administration scenarios with appropriate analytical support.
Our team brings extensive experience with regulatory requirements for container-closure qualification and understands the complex relationships between packaging materials, formulation components, and product performance, enabling us to provide practical recommendations that balance product protection with manufacturing feasibility and regulatory compliance.
We provide actionable outputs, not just
observations. Our team integrates
structural biology, data science
and formulation development to deliver a single coherent story—risk scores, liabilities and
hypotheses that directly inform design of
experiments and decision points. Beyond
assessment, we offer connected services
so your program can move seamlessly into
optimization, extended stability packages
and small-scale non-GMP manufacturing
without losing momentum.
See: Non-GMP Processing &
Let’s Build the Right Formulation — Together
We model monoclonal antibodies, bispecific formats, antibody-drug conjugates, fusion proteins, enzymes, therapeutic peptides, and other engineered biologics, with specialized capabilities for complex conjugates and novel protein architectures.
Proof and Resources
Explore our developability expertise through our webinars
New Publication
Identification of relevant analytical methods for adeno-associated virus stability assessment during formulation development
Read it now!
New Webinar
Smart Drug Product Development: Rational formulation designs for highly concentrated biologics
Wednesday, June 25, 2025 · 4:00 p.m. Amsterdam (GMT +2:00)
New Publication
Identification of relevant analytical methods for adeno-associated virus stability assessment during formulation development
Read it now!
Latest News
Jun 30, 2025
Identification of relevant analytical methods for adeno-associated virus stability assessment during formulation development
Formulation of adeno-associated viral (AAV) vectors requires analytical methods that are predictive of stability, use minimal material, and allow high-throughput testing—criteria that are often difficult to meet. This exploratory study assessed several analytical techniques for their ability to predict or indicate AAV stability. Two methods emerged as particularly promising: extrinsic differential scanning fluorimetry with SYBR Gold for genome release detection, and nano differential scanning fluorimetry for capsid stability. Size-exclusion chromatography with multi-angle light scattering and UV was also effective for monitoring particle size and genome load.
May 30, 2023
An exploratory study on the effect of mechanical stress on particle formation in monoclonal antibody infusions
Monoclonal antibody infusions face risks of particle formation from transport stress, especially at low concentrations. Studies show pembrolizumab and bevacizumab are most affected, highlighting the need to minimize storage time, vibration, and syringe particle entry.
Oct 12, 2022
Efficient stabilization of therapeutic hepatitis B vaccine components by amino-acid formulation maintains its potential to break immune tolerance
JHEP Reports. 2023 Feb; 5(2): 100603
SACHERL J. ET AL: Efficient stabilization of therapeutic hepatitis B vaccine components by amino-acid formulation maintains its potential to break immune tolerance
Nov 9, 2018
Rentschler Biopharma SE / LEUKOCARE AG/ Informa Pharma Intelligence
Rentschler Biopharma SE / LEUKOCARE AG/ Informa Pharma Intelligence
"2018 Survey- Formulation in the Drug Product Development Process": 2018 Survey ‘Formulation in the Drug Product Development Process’, based on research from Informa Pharma Intelligence
Apr 20, 2010
Jun 30, 2025
Identification of relevant analytical methods for adeno-associated virus stability assessment during formulation development
Formulation of adeno-associated viral (AAV) vectors requires analytical methods that are predictive of stability, use minimal material, and allow high-throughput testing—criteria that are often difficult to meet. This exploratory study assessed several analytical techniques for their ability to predict or indicate AAV stability. Two methods emerged as particularly promising: extrinsic differential scanning fluorimetry with SYBR Gold for genome release detection, and nano differential scanning fluorimetry for capsid stability. Size-exclusion chromatography with multi-angle light scattering and UV was also effective for monitoring particle size and genome load.
May 30, 2023
An exploratory study on the effect of mechanical stress on particle formation in monoclonal antibody infusions
Monoclonal antibody infusions face risks of particle formation from transport stress, especially at low concentrations. Studies show pembrolizumab and bevacizumab are most affected, highlighting the need to minimize storage time, vibration, and syringe particle entry.
Oct 12, 2022
Efficient stabilization of therapeutic hepatitis B vaccine components by amino-acid formulation maintains its potential to break immune tolerance
JHEP Reports. 2023 Feb; 5(2): 100603
SACHERL J. ET AL: Efficient stabilization of therapeutic hepatitis B vaccine components by amino-acid formulation maintains its potential to break immune tolerance
Nov 9, 2018
Rentschler Biopharma SE / LEUKOCARE AG/ Informa Pharma Intelligence
Rentschler Biopharma SE / LEUKOCARE AG/ Informa Pharma Intelligence
"2018 Survey- Formulation in the Drug Product Development Process": 2018 Survey ‘Formulation in the Drug Product Development Process’, based on research from Informa Pharma Intelligence
Apr 20, 2010
Jun 30, 2025
Identification of relevant analytical methods for adeno-associated virus stability assessment during formulation development
Formulation of adeno-associated viral (AAV) vectors requires analytical methods that are predictive of stability, use minimal material, and allow high-throughput testing—criteria that are often difficult to meet. This exploratory study assessed several analytical techniques for their ability to predict or indicate AAV stability. Two methods emerged as particularly promising: extrinsic differential scanning fluorimetry with SYBR Gold for genome release detection, and nano differential scanning fluorimetry for capsid stability. Size-exclusion chromatography with multi-angle light scattering and UV was also effective for monitoring particle size and genome load.
May 30, 2023
An exploratory study on the effect of mechanical stress on particle formation in monoclonal antibody infusions
Monoclonal antibody infusions face risks of particle formation from transport stress, especially at low concentrations. Studies show pembrolizumab and bevacizumab are most affected, highlighting the need to minimize storage time, vibration, and syringe particle entry.
Oct 12, 2022
Efficient stabilization of therapeutic hepatitis B vaccine components by amino-acid formulation maintains its potential to break immune tolerance
JHEP Reports. 2023 Feb; 5(2): 100603
SACHERL J. ET AL: Efficient stabilization of therapeutic hepatitis B vaccine components by amino-acid formulation maintains its potential to break immune tolerance
Nov 9, 2018
Rentschler Biopharma SE / LEUKOCARE AG/ Informa Pharma Intelligence
Rentschler Biopharma SE / LEUKOCARE AG/ Informa Pharma Intelligence
"2018 Survey- Formulation in the Drug Product Development Process": 2018 Survey ‘Formulation in the Drug Product Development Process’, based on research from Informa Pharma Intelligence
Apr 20, 2010
FAQ
Which molecule classes do you work with most often?
What is SMART Formulation® and how does it differ from classic screening?
How long does a typical formulation project take?
Can you supply non-GMP material for pre-clinical studies?
FAQ
Which molecule classes do you work with most often?
What is SMART Formulation® and how does it differ from classic screening?
How long does a typical formulation project take?
Can you supply non-GMP material for pre-clinical studies?