Drug Product Release Specification Justification

Client lacks knowledge of critical quality standards for drug product release

  • Specifications are critical quality standards that are crucial for approval when submitted to the authorities

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Data Science long-term support to a global submission dossier

Needed to perform multiple calibration studies for IVD

  • Statistical and pharmacokinetic input in each application dossier (e.g. modules 2.7.2 and 5 for FDA)
  • Need to summarize heterogeneous information from different sources and providers used during the clinical development
  • Quick feedback including new analyses to support the answers to the questions raised by the different regulatory agencies

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Tolerance intervals solution

Reluctance to compute tolerance intervals

  • Scientists in the pharma industry are reluctant to compute tolerance intervals and therefore cannot assess the control limits for each analytical method and process rapidly

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Setting calibration frequency for an IVD

Needed to perform multiple calibration studies for IVD

  • A client selling In VitroDiagnostics (IVD) tools had to perform laborious studies to establish the frequency of calibration to be applied on their IVD tools
  • Knowing that the required calibration frequency is directly linked to the stability of the reagents used, why not use stability data to predict a calibration frequency that still guarantees performance of the assay?

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System suitability control limits for assay with format

Client lacked sufficient knowledge of System Suitability Control (SSC)

  • For assays, scientists develop SSC, to mitigate large assay variability with biologics and vaccine, samples are frequently analyzed in replication over multiple runs, and the mean of all the results is taken as reportable value
  • Variability analysis of these replicates could lead to the detection of assay problem (sample preparation, etc.) but specifications for simultaneous, replicate determinations do not exist to obtain an easy pass / fail decision process

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Preparing for process characterization activities

Support required for process characterization activities

  • The client has produced several batches of product and wishes to use the different results from the manufacturing campaign to start process characterization activities
  • A large dataset is provided containing information on process parameters and material attributes across the process
  • Client project was blocked due to lack of internal process characterization capabilities

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Setup an Atlassian product (Jira, confluence)

Client wants to implement a WIKI or a Bug Tracking Tool via an Atlassian Product

  • A client in need of custom wiki or of a bug tracking tool but lacking expert knowledge and resources to handle the technical part internally

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Validation of SoftMaxPro

Client experienced troubles implementing a protocol validation in SoftMaxPro

  • Definition of the expected results and path were complex
  • Protocol needed to be reworked several times before reaching acceptance

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Development and Implementation of the Robustness Index

Support required to provide success criteria in line with QbD principles

  • Implementation of a Robustness Indexaiming to translate development goals into objectively measurable success criteria to assess scientific knowledge, development and performance data to promote Quality by Design (QbD) principles in manufacturing

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Dilution recipe for vaccine production

Required support to avoid batch rejection due to poor assay performance

  • A vaccine manufacturer produced a bulk drug Substance (DS)
  • Dilution with a formulation buffer is made to obtain a Drug Product ready to be filled in syringes
  • However, the titration of biologic material is subject to large uncertainty due to poor assay performance, leading to frequent and costly batch rejection

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Implementing parallelism tests in JMP

Client was in urgent need for a more cost-effective solution

  • According to (statistical software) USP standards, parallelism between a pair of dose–response functions need to be tested prior to validating a potency bioassay
  • Developing acceptance criteria for one specific assay requires measuring the reference product numerous times
  • These cost a tremendous amount of time and money

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Continuous Manufacturing: Development, Optimization and Validation

Client lacks strategy for Continuous Manufacturing within QbD principles

  • Client lacks experimental strategy to develop, optimize and validate a new continuous Manufacturing (CM) process in Quality by Design (QbD) framework

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Bayesian modelling and prediction of patient recruitment

Required support for recruitment of patients for clinical trials

  • In many clinical trials, the amount of time needed to recruit the targeted number of patients is underestimated
  • Failure to recruit enough patients in the planned time frame causes delays, additional costs, etc
  • Consequently, estimating the recruitment duration is of crucial importance for the proper conduct of the trial

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Automatic detection of disease events based on accelerometer data

Manual process for recording data was unreliable and expensive

  • The client installed accelerometers on mice to record disease events
  • The system detected c.100 false positives for each real event
  • Results needed to be reviewed and corrected manually by experts
  • Data accuracy critical as data set was aimed to be used in pre-clinical trials to compare different treatments

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Analytical Method Comparisons

Client needed to demonstrate interchangeability of technology

  • Client needed to change from a costly and low through-put analytical technology, to an easier, faster high through-put assay

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Acceptance criteria for Bioassay validation

Client was in urgent need for a more cost-effective solution for Bioassay validation

  • According to USP standards, parallelism between a pair of dose-response function needs to be tested prior to validating a potency bioassay

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Computer Software Validation for Multinational Pharmaceutical Company

Pharmaceutical company acquires a European company and needs to expand in European market

  • Executive management needed deployment of ERP system at the acquired European site to support the anticipated increase in business volume and complex supply chain model
  • The pharmaceutical corporation needed computer software validation to meet US and EU regulatory requirements followed at other company locations
  • Validation efforts necessitated remote support to work alongside implementation team

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Portfolio Maintenance Outsourcing Local RA responsibility – EU

Client plans to outsource RA activities in EU countries for defined products

  • High workload in local affiliates for established product portfolio in the EU
  • New products registered in the countries lead to increasing workload
  • Full RA responsibility for an established product portfolio to be outsourced for 16 EU countries
  • Cover of all RA life cycle management tasks including labeling and interaction with local partners (incl. PV, medical)
  • HA interactions done directly by PharmaLex

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Pre-IND Meeting for an antibody-drug conjugate (ADC) for an advanced cancer indication

Client in need of expertise for IND development and FDA interaction for First-in-Human study

  • European SME beginning first discussions with the FDA regarding IND development and submission of an ADC product for an advanced cancer indication
  • Intent to gain agreement on completed nonclinical program to support first in-human (FIH) study

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End of Phase-2 meeting

European client entering a pivotal program in a competitive market

  • EU based company developing a gastrointestinal product in a competitive and controversial market (opioids)
  • The company intends to pursue adaptive Phase 2/3 clinical program to expedite late-stage development
  • Company intent to gain agreement from FDA on completion of non-clinical and CMC (quality) program to support marketing approval

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Strategy and delivery of global biosimilar development program

Needed expertise for biosimilar regulatory strategy and support with execution

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