Issue: April 2017, Posted Date: 4/3/2017
EXECUTIVE INTERVIEW - Vetter: Establishing a Successful Clinical Fill & Finish Manufacturing Site for Biologics
Small biotech companies are faced with
a series of issues when it comes to early drug development. One such issue is
the critical lack of experience in key areas, which leads to employees’
multi-tasking, having less internal expertise for manufacturing and sourcing, and
an increased reliance on outside expertise. They also face a lack of financial resources
and limited access to capital. With less patience expressed by the investor due
to their inability to find the time to communicate their progress, securing
additional funding is difficult. Finally, their high-value compounds often have
limited availability and generating enough of the compound for the development
phase is a challenge, with long lead times for their API being common. The
right partner can support the small biotech by offering an additional level of
resources and expertise, help enable right-first-time, result-saving costs and
provide support through flexibility and problem-solving to handle investor
communications for the next funding milestone. They can also help to optimize
yield through equipment and process strategies (eg, filling machine design, multipurpose
sampling, etc). Having the right site is crucial in serving the customers’ needs.
It is now 5 years since Vetter opened its clinical fill & finish facility
in Chicago, successfully serving its customer base with their needs in mind.
What are the specific needs of the small biotech and how is Vetter helping them
to meet them? Drug Development & Delivery recently
interviewed Dr. Susanne Resatz, President of Vetter Development Services USA,
Inc., to discuss the many benefits to small biotech companies in utilizing the
services of a full-service CDMO, and what advanced services the Chicago-based facility
offers its growing customer base.
our readers who are not yet familiar with your company, can you briefly discuss
Vetter and what service portfolio it offers?
is an independent contractor development and manufacturing organization (CDMO)
specializing in the aseptic filling of syringes, cartridges, and vials. Our
state-of-the-art facilities located in the US and Europe provide support for
early stage drug products, with seamless transfer to Vetter Commercial
Manufacturing for large-scale production. In addition to these locations, in November
2014, taking advantage of a rapidly growing Asian healthcare market and to better
support our customers and develop new business, we announced the opening of our
first Asian office in Singapore, and in October 2015, we announced the opening
of new business office in Tokyo.
As a world-leading CDMO, we
have extensive experience in working with biologics and other complex
compounds, including monoclonal antibodies, peptides, interferons, and
vaccines. And, because we are a full-service provider we can support our
customers’ products throughout their lifecycles, from preclinical development
through global market supply. We are the originator of dual-chamber technology,
which enables easier, safer lyophilized drug administration, and we are a
leader in the use of RABS technology in cleanrooms, which mitigates risk of
product contamination throughout the manufacturing process. Finally, it is important
to note that as a family owned independent company, we do not manufacture our
own drugs but focus solely on our customers’ product success.
small biotech needs additional experience, so how did Vetter build up skills
and the right structure?
intent was to create a new facility with a knowledge base anchored in Vetter systems.
We began by first focusing on the skills that would be necessary for the
customers we wanted to serve. Once determined, we constructed a team of Vetter
Ravensburg employees who had the essential knowledge base in the different
areas and systems. They were further trained at Ravensburg prior to relocating
to Chicago. We also hired from the local Chicago pharmaceutical/biotech talent
pool, which is quite substantial given the nature of the surrounding area with
its many universities and varied pharmaceutical industry. Every employee had to
have the technical and industrial knowledge as well as the customer experience
that would match the needs of our customers. Next, we focused on the structure
of the team itself, aiming for a balance of site and corporate resources that
had all key functions on site. As critical mass was achieved, we added support
functions as necessary. Our project teams were created using the existing Vetter
project team structure and project management tools. Our customers were assured
there would always be easy access to our support staff of specialists, and we
allowed for a direct relationship between the customer and Vetter’s subject
matter experts (SMEs). Finally, we encouraged strong ties to our commercial production
teams through ongoing visits to our Ravensburg site for regular meetings with
their commercial counterparts.
can the right capabilities (building & facility) serve the needs of small
biotechs, how did Vetter approach it?
A: The key
to serving the needs of our smaller biotech customers is in our overall approach
to layout and material flow. We see this as a three-step process. In the first
step, we need to allow for close proximity of manufacturing and testing spaces.
To achieve this, we designed the facility to allow for compounding adjacent to
the filling area with the visual inspection area adjacent to the cold storage
area. Chemical and micro labs are next door to manufacturing. Second, in order
to limit the time materials are at room temperature, we installed the freezers
and refrigerators adjacent to manufacturing. Third, to maximize usage of
limited storage space, we only expand the space as needed and make use of qualified
portable units for cold and frozen storage.
As for how we approach
serving the needs of small biotechs, we aim to do it - “right the first time.”
In order to achieve this goal, we incorporate multiple formats of equipment
that result in minimum line losses and maximum yield. Our machines allow for a high
level of environmental control but also easy changeovers. Our systems are
scalable and have the ability to transfer to commercial lines. For example, we
use RABS technology on all Vetter lines. Our yields are 100% in-line check
weigh for vials, and we also have handling units for vial filling. Our approach
is to establish platform processes that minimize risk through technical batches
and machine runs. We minimize line losses and maximize yield by optimizing our
tubing and break tank. Our operators are focused on yield, which is tracked as
KPI. We are always focused on ways to improve. Wherever feasible, our clinical processes
are a scaled-down version of established commercial processes. Finally, our
documentation is consistent, which allows for easier identification of gaps
to the lack of financial resources, are timelines and scheduling important topics?
timelines and batch scheduling are an important consideration in manufacturing
processes. The quick implementation of new products means we use platform
processes and materials and project schedules that focus on GMP batch
manufacturing dates. We are well aware of our timeline commitments and set and
track project milestones as KPIs. We also maintain open communication with our
customers so that the risks involved in the project are transparent. We allow
for flexibility in our scheduling to support capacity reserve each month, and
we schedule meetings with project managers and SMEs to quickly address any
risks or changes.
how did the Chicago site perform within the past 5 years?
A: We are
extremely pleased with our past years’ performance at this facility, and our overall
success to date. Many of our customers have returned for development work for a
second, third, or even fourth molecule. Furthermore, our outlook for future performance
is very positive as demonstrated by a solid pipeline filled with high-quality customer
projects for biologics. We have solid experience with more than 60 compounds,
and have already made more than 5 transfers to our European facilities for development
and commercialization with more to follow in the near future. And, it is heartening
to know that the drugs that we are developing at this facility for our
customers are then used to help people around the world. Drugs we have under
development for our customers include treatments for blood cancer, muscular dystrophy,
wound healing, and dwarfism.
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