SPONSOR EXPECTATIONS
BioPharm: How have sponsor companies' expectations for biopharmaceutical contract manufacturing changed over the past three to five
years? Please provide an example or two. What do you think led to these changes?
Zinselmeier (Baxter): We have seen an increased interest in the use of disposables (i.e., single-use systems) for biopharmaceutical manufacturing.
This approach has the potential to save the client time and money, but introduces a new set of challenges related to compatibility
of the disposable materials and the formulation. Disposable providers have been publishing information relative to this topic
and this has been very helpful. Our clients have shown interest in this technology for the advantages it potentially offers
for project timelines.
Additionally, a larger trend in contract manufacturing is the standardization of processes during clinical manufacturing,
which applies to biopharmaceutical manufacturing as well. Clinical manufacturing is challenging in that, generally speaking,
there are many manufacturing unknowns. Much of this uncertainty is due to the timing, because process work has not been fully
developed at this stage. What we have seen is an increased understanding that there is benefit to standardizing whatever you
can for clinical projects, creating a tool kit so to speak. One example is identifying particular vials, stoppers, and syringes
that will be used in clinical manufacturing. It seems simple, but we have found that it requires commitment from the technical
teams, and there has been interest in implementing this type of system in order to reduce project timelines.
Payne (Catalent): Expectations related to the quality attributes of a facility (i.e., fit and finish and material flow) continue to rise, as
do expectations related to on-time delivery. Companies like ours that have a track record of reliable delivery and that continue
to invest in facility upgrades are rewarded by our customers with repeat business. Our customers' expectations vary dramatically.
We add value through regulatory expertise and by helping them with risk-benefit discussions associated with their projects.
We believe solutions need to be tailored to a company's needs.
Sampathkumar (Hospira): Sponsor companies have increased expectations for contract services mainly due to increased QbD and regulatory expectations
in recent years. The failures or warning letters associated with commercial biologic products (even those in the market for
more than a decade) as well as with manufacturing plants have led to these changes.
One specific examples of clients' expectations are having integrated sterilization and drug product filling lines. Another
is that increased concerns about the immunogenicity potential of subvisible particles in biologics has led to more stringent
requirements in particulate control in the drug product.
QUALITY-BY-DESIGN
BioPharm: Along these lines, have you witnessed more interest in QbD approaches from sponsor companies? Has your company applied a
QbD approach to date or does it plan to?
Zinselmeier (Baxter): We are starting to see clients identify critical quality attributes of their product which we can then integrate into the
manufacturing process and related validation activities. Clients have an intimate understanding of their product, and we can
help them identify attributes that affect the manufacturing process and therefore implement a QbD approach.
Wolff-Long (Cangene): From the sponsor companies, no. From the regulatory agencies, absolutely. It is not feasible to fulfill the regulatory requirements
without cooperation from the sponsor companies.
We are building QbD into our quality systems at this time—but more around the facility and equipment. As a CMO, we can't understand
the technical details and history of the product, so it will take careful planning and more partnership when developing and
defining the actual manufacturing process parameters.
Payne (Catalent): Yes, we have applied QbD for several years across our various platforms and are committed to continuing to do so.
Sampathkumar (Hospira): QbD should be an integral part of manufacturing operations at any biologic manufacturing facility. Implementation of QbD may
initially require increased diligence and resources to understand process impact on product quality (especially CQAs). However
the benefits to business include substantial reduction of batch failures as well as savings associated with number of successful
runs; improved quality environment; and better credibility with client companies and regulatory agencies that will aid in
increased business versus other CMOs.
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