Our consulting services

Our consultants will help you succeed by delivering value in the areas listed below.

Increase speed of delivering your biopharmaceuticals to market by helping develop efficient commercialization strategies.

  1. Proper analytical method development is crucial to successfully commercialize products. We can help you develop methods to measure and control critical quality attributes, to work reliably and efficiently in the Quality Control environment, to enable easy and successful technology transfers, to have fit-for-purpose system suitability criteria, and to successfully meet pre-defined acceptance criteria that measure and control method performance over its lifecycle.

  2. Defining when and how to qualify and validate analytical methods is key to a phase-appropriate product commercialization lifecycle that enables successful regulatory approval. Our experience in developing and improving qualification and validation strategies, and developing appropriate acceptance criteria, has led to vastly improved method validation successes and efficiencies.

Apply industry leading statistical methods to maximize the value of your studies

We can successfully apply and train you in best practice statistical methods for design of experiments, method validation, method transfer, comparability testing, demonstration of analytical similarity for biosimilar products, acceptance sampling, stability testing, and measurement systems analysis.

Decrease your cost of Quality Control by developing robust and efficient analytical control strategies

  1. We can help you develop efficient and successful process control testing points and sample plans for process development and GMP manufacturing quality control. Using our plans, you can be confident you are performing appropriate and sufficient testing that will provide the data required for an adequate control stategy.

  2. Developing an appropriate drug substance and drug product specification strategy can ensure efficient use of Quality Control resources, and reliable product supply with low out of specification rates and high Ppk. We can help you develop specifications and specification ranges that ensure your product is safe and efficacious, without creating unnecessary non-conformances during product release and stability testing.

  3. Stability testing represents one of the most costly areas of Quality Control. Our experience in protein formulation development and stability study design can help you develop an efficient GMP stability program that will keep costs down while meeting regulatory expectations.

Creating clear and concise IND, INDa and BLA regulatory submissions that meet world-wide regulatory expectations

Our scientists have directly authored multiple IND, INDa, and BLA submissions. Every submission we have authored has resulted in regulatory approval with minimal regulatory questions. We have continually improved the authoring process and can guide you through it or even help author regulatory sections on elucidation of structure, drug substance and drug product impurities, reference standard qualification, specifications, stability, comparability, biosimilarity and integrated control strategy. When regulatory agency questions arise, we can help you successfully address them to ensure rapid product approval.

Ensure product supply by helping you troubleshoot and resolve process and analytical issues and non-conformances

Due to the complexity of biological products, unexpected issues can arise during manufacturing and quality control testing: an out of specification result, a Nelson rule violation, or an unexpected result that may pass specification but still appear unusual. We have decades of experience dealing with these types of issues, and have been highly successful at quickly determining root cause and corrective actions. Whether it’s an impurity discovered during testing, an unusual particle profile, product degradation, chemical modification, glycan profile shift, or an unusual color in a drug substance or process pool, we can help you solve the issue and resume manufacturing.

Improve success rates and speed of Comparability and Biosimilarity exercises

Comparability exercises enable an objective assessment of the impact of manufacturing changes (site changes, scale changes, unit operation changes, etc.) by comparing the pre-change and post-change product profiles using specification methods, characterization methods, and stability assessments. Biosimilarity exercises enable an objective assessment of the biosimilar product to the innovator product. Our experience in these areas enables us to efficiently and successfully design these studies, including right-sized selection of tests, designing sample plans, developing protocols and fit-for-purpose acceptance criteria, and delivering comprehensive statistical and scientific evaluation of results.

Let us help you succeed

Products Developed

21

Average Years of Industry Experience

19

Our Expertise

On average, members of the Elion team have over 15 years of direct experience in the biopharmaceutical industry, largely focused on bringing clinical products to market as well as lifecycle management of commercial protein products.  We have directly supported world-wide regulatory applications for registration of multiple biologics by authoring and reviewing CMC components of those applications, including elucidation of structure, drug substance and drug product impurities, reference standard qualification, specifications, stability, comparability, biosimilarity and integrated control strategy sections.  

Furthermore, our team has extensive experience with product characterization requirements, including meeting regulatory expectations for biochemical, biophysical, particle, and degradation pathway characterization.  Our team has supported over 100 comparability studies, 30 stability studies, and 20 reference standard qualifications.  We have developed and implemented universal characterization methods, qualification approaches, and acceptance criteria, leading to significantly increased efficiency in the application of analytical methods.  

We have a proven track record in gaining regulatory approval in multiple jurisdictions for reductions in Quality Control analytical testing by creating science-based justifications to eliminate redundant or non-value added tests and focusing testing on the most relevant product quality attributes.  We have developed rapid analytical test methods, improved data analysis methods, and statistical biosimilarity strategy for demonstrating overall similarity of biosimilar products to innovator products.  At Elion, we are committed to using appropriate technologies, sophisticated data analysis, and our prior experience to provide significant value to our clients.  

Latest Publications

  

Guidance to Achieve Accurate Aggregate Quantitation in Biopharmaceuticals by SV-AUC

The levels and types of aggregates present in protein biopharmaceuticals must be assessed during all stages of product development, manufacturing, and storage of the finished product. Routine monitoring...

  • K Arthur, B Kendrick, J Gabrielson
  • |
  • July 10, 2015

Technical Decision Making with Higher Order Structure Data: Higher Order Structure Characterization During Protein Therapeutic Candidate Screening

Protein therapeutics differ considerably from small molecule drugs because of the presence of higher order structure (HOS), post-translational modifications, inherent molecular heterogeneity, and unique stability profiles. At early stages of development...

  • Y Jiang, C Li, J Li, J Gabrielson and J Wen
  • |
  • February 25, 2015

Technical Decision-Making with Higher Order Structure Data: Starting a New Dialogue

Characterization of the higher order structure (HOS) of biological products has been growing in importance in recent years. Scientists in the biopharmaceutical industry, academic researchers, and regulators are all increasingly aware of the critical role that HOS plays

  • J Gabrielson and W Weiss
  • |
  • February 24, 2015

Contact Us

We look forward to partnering with you on your path to product commercialization.