CMOS' FUTURE
BioPharm: From a CMO perspective, where do you see biopharmaceutical outsourcing in five to 10 years from now? What key changes may
have occurred by then?
Zinselmeier (Baxter): As the volumes associated with biopharmaceuticals evolve, we believe we will see the need for more flexible manufacturing.
New drug approvals will continue, but the volume associated with each particular molecule is decreasing. This requires a shift
in capacity and services so that manufacturing resources can adapt to the new requirements and remain an efficient option
for pharmaceutical clients.
Wolff-Long (Cangene): I think that large pharma will continue to outsource and provide opportunity for CMOs. One of the key challenges continues
to be alignment of quality systems at the CMO and sponsor companies. In the environment of continuous improvement, change
is absolutely required for compliance, but at the same time, change requires varying levels of review, documentation, and
notification that can constrain implementation of new processes.
Payne (Catalent): Over the next few years, outsourcing will continue to grow as big biotechs want less risk of overcapacity in manufacturing.
We will also see a stronger presence globally serving local geographies. Working with partnerships to address global needs
locally is an approach we have ourselves taken, for example, our partnership with Toyobo Biologics. There will continue to
be a focus on speed, which benefits from technologies like Catalent's GPEx expression platform. We expect to see further improvements
in downstream processing innovation.
Sampathkumar (Hospira): The changes that I foresee in biopharmaceutical outsourcing over the next 5–10 years are:
- Low cost, high speed production of high quality biologics as margins as well as quality become important for biosimilars/biologics
production.
- Mandatory requirement for implementation of key Qbd concepts (i.e., process understanding/characterization; impact on CQAs)
in biopharmaceutical outsourcing.
- Increased need for process analytical technologies (PAT) and automation (e.g automated visual inspection).
- Better risk management in terms of alternate vendor assessment for raw materials.
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