Accelerating Biologics Manufacturing
In today’s world, pharma and biotech industry is constantly driving to shorten development time and gain faster approval for their high quality therapies. Biologics, from DNA to proteins, present unique and time-consuming challenges whereby factors such as cell line and analytical development, biologic instability, scale up, and limited capacity may negatively impact time to market and budget outcomes.
“Speed to milestone” “Speed to Market” “Speed to Patient” are words well known for all biopharmaceutical and pharmaceutical drug developers
By knowing in advance, the influence of different manufacturing events on a biologic and being able to provide supporting data to back up these occurrences through process characterization, the risk of manufacturing failures and regulatory time delays is significantly reduced.
Below we show you 5 steps to create a successful strategy that will help accelerate time to a robust and reliable commercial scale process.
Create a Strategy to Accelerate Biologics Manufacturing
Step 1: Define a Master Plan for Biologic Manufacturing
This master plan has to describe the manufacture and evaluation of the biologic from start to finish, including strategy and rationale for approaches to small-scale characterization and full-scale validation.
The master plan has to ensure a well thought-out, justified and complete process characterization.
Step 2: Risk Assessments Evaluation
A risk assessments has to be performed on process characteristics and product quality attributes, where a list of parameters are evaluated. In order to prevent the duplication of work, you can refer to risk assessments carried out for a previous process characterization project.
Step 3: Characterize the Cell Culture and Purification Processes
The characterization of these processes must be done into these five activities:
- Laboratory scale-down models
- Process mapping
- Proven Acceptable Range (PAR) studies
- In-process sample stability
- Impurity clearance
Step 4: Post-Characterization Risk Assessment
A second round of risk assessments has to be done based on the data generated from process characterization studies. The outcome is going to be a listing of critical and non-critical parameters, as well as a ranking of the critical process parameters.
Step 5: Process Justification Report
The overall control strategy report for manufacturing the biologic provides justification of the proven acceptable ranges for manufacturing operating parameters, being also a basis for process validation.
CDMO as a Partner
Pharma and Biotech companies involved in the clinical development of a Biologic are wise to partner with an experienced CDMO, who has the biologics expertise, resource and facilities to handle this important stage of a drug’s lifecycle. Successful process characterization is a critical factor in driving faster progression to regulatory approval and market.
Experienced CDMOs offer many advantages, because they have performed many process characterization studies on a range of Biologic candidates.
The CDMO offers a well-established platform for planning, assessment, analytical studies, data analysis, and review to support market approval.
Another advantage is that an experienced CDMO will have in place the necessary, and often costly equipment required for biopharmaceutical testing, accompanying this with a pool of highly experienced personnel.
53 Biologics offers wide-ranging expertise in development, scale-up, validation and transfer of bioprocesses
Thorough process characterization provides a full understanding of the biopharmaceutical and the processes under which it can be efficiently, compliantly manufactured for safety, purity, and potency.
If the process characterization has not been performed correctly, this can lead to issues with regulatory compliance or manufacturing performance. In other words, these can force costly re-work and substantial time delays in getting to market or can result in tight tolerances for the proven acceptable ranges, greatly restricting manufacturing.
Employing operational excellence and experienced biologics development teams provide opportunities to compress the development timeline while minimizing the risk profile.
To assist in reducing client timelines and milestone achievement, 53Biologics incorporates a methodology using a holistic risk assessment and project needs assessment to construct a flexible project plan and timeline.
53biologics supports a broad range of contract manufacturing services.