In today’s pharmaceutical and biotechnology industry, the focus is on reducing development time and obtaining faster approval for high-quality therapies. However, biologics present unique and time-consuming challenges, such as cell line and analytical development, biological instability, scale-up and limited capacity, which can negatively impact time to market and financial results.
Here are 5 steps to create a successful strategy that will help accelerate the time to a robust and reliable commercial-scale process.
Create a Strategy to Accelerate Biologics Manufacturing
Step 1: Develope a Master Plan for Biologic Manufacturing
This master plan should outline the entire biologics manufacturing and evaluation process, including strategy and justification for small-scale characterization and full-scale validation.
The master plan should ensure thorough, well-thought-out, and comprehensive process characterization.
Step 2: Risk Assessments Evaluation
Conduct a risk assessment of process characteristics and product quality attributes, evaluating a list of parameters. To avoid duplication of effort, you can consult risk assessments conducted for previous process characterization projects.
Step 3: Characterize the Cell Culture and Purification Processes
Characterization of these processes should be conducted through these five activities:
- Laboratory scale models
- Process mapping
- Proven Acceptable Range (PAR) studies
- In-process sample stability
- Impurity removal
Step 4: Post-Characterization Risk Assessment
Conduct a second round of risk assessments based on data generated from the process characterization studies. The outcome will be a list of critical and non-critical parameters and a classification of critical process parameters.
Step 5: Process Justification Report
The report of the overall control strategy for biologics manufacturing provides the justification for proven acceptable ranges for manufacturing process operational parameters and serves as a basis for process validation.
CDMO as Partner
Pharmaceutical and biotechnology companies involved in the clinical stage of biologic product development must collaborate with an experienced CDMO that has the appropriate skills, resources and facilities to manage this crucial phase in a drug’s life cycle. Efficiency in process characterization is key to accelerating the path to regulatory approval and commercialization.
Experienced CDMOs have numerous advantages, as they have extensive knowledge in process characterization across a wide variety of biologics.
The CDMO provides a solid framework for planning, evaluation, analytical testing, data analysis and review that supports the commercial approval process.
In addition, an experienced CDMO will possess the expensive and essential equipment required for biopharmaceutical testing, as well as a highly trained and experienced team.
53 Biologics offers wide-ranging expertise in development, scale-up, validation and transfer of bioprocesses
A rigorous process analysis provides a thorough understanding of the biologic drug and how it can be produced efficiently and in compliance with safety, purity and potency standards.
If the process assessment is not conducted properly, difficulties in regulatory compliance or production efficiency can arise. These problems can result in costly rework and significant delays in commercialization or limit production by imposing tight tolerances for the evaluated acceptable ranges.
The use of expert teams and operational excellence in biologics development offers the potential to shorten development timelines and minimize the risk profile.
To help reduce its clients’ timelines and achieve objectives, 53Biologics takes an approach that combines a comprehensive risk assessment and a project needs assessment to create a flexible project plan and schedule.
53Biologics offers a wide range of contract manufacturing services.