Large Pharma Supply Manufacturing Services - 5 year OTIF>95%

1. CASE STUDY
Five Year Trouble-Free
Manufacturing Services for a
Large Pharmaceutical Company
Summary
Elan Drug Technologies’ (EDT) Manufacturing Services business has been manufacturing commercial scale solid oral
dosage products for over 30 years. The case study below demonstrates a large pharmaceutical contract manufacturing
engagement in which there has been five years trouble free supply with OTIF (On-Time-In-Full) consistently >95%.
Process and product improvement initiatives were also delivered by EDT which resulted in significant capacity and yield
improvements. These improvements resulted in significant cost savings for the client.
Project History The Result
In 2004, EDT was approached by a large international A number of significant achievements resulted from the involvement
pharmaceutical company, to supply manufacturing services for a of EDT with this project. Robust process development and tech
solid oral dosage product. transfer was accomplished in significantly less time than the client’s
best case time estimate for the project.
This marked only the second time this large pharmaceutical
company sought assistance (pre-launch) from a third party to • he entire process including equipment build and qualification,
T
manufacture a product on its behalf. and process development took less than 10 months
EDT’s Athlone, Ireland site was chosen as the preferred site to fulfil • DT moved directly into 24/7 production from validation,
E
the expected commercial demands of the product as the launch immediately fulfilling a commercial run-rate for this multi-coated
was being rolled out throughout Europe. bead product of >100 batches/annum (up to 340 million doses)
Why was EDT Chosen? • rocess and product improvement initiatives were delivered
P
EDT’s manufacturing capabilities were chosen because they met and/or demonstrated to deliver, with significant capacity and
the client’s dual requirements of experience and expertise in solid yield improvements realised:
oral development and manufacturing. The manufacturing capacity – Combined cycle processing championed by EDT delivered
afforded by the Athlone facility together with its excellent compliance a capacity increase of 22% – EDT’s approach was later
record of supplying product from an FDA/EMA-inspected site implemented in the client’s own facilities
provided the large pharmaceutical company with the assurances
it required to outsource its manufacturing requirements to EDT. – One process improvement resulted in an increased return on
EDT also had well-established credentials in delivering process active ingredient. This resulted in a 25% increase in active
improvements for clients. 26 products have been manufactured in pharmaceutical ingredient (API) yield per batch – a significant
the Athlone site since the 1970s - the majority of which are solid oral cost saving that was passed on to the client
dosage forms. – Through EDT’s reformulation of the product, a significant
The Challenge increase in active loading of the bead of 35.5% was gained
The immediate challenge was to develop a high yield, robust – Process scaling achieved through use of process
process to manufacture a multi-coated enteric-coat product development scale Glatt 5 and 30 equipment enabled further
where other companies had experienced significant problems in optimisation and cycle development away from commercial
aggregation and in functional coat failure. An additional challenge cGMP and cost constraints associated with large scale
was to deliver quickly a solution as the product had high volume processes
requirements for launch.
EDT manufactured at full capacity for more than 5 years consistently
EDT’s Athlone Site delivering OTIF in excess of 95% and ranking at or close to the top
Located on a 40-acre site, with over 220,000 square feet of the client’s league table of suppliers. Over the 5-year period, more
of dedicated cGMP grade facilities, this site has a proven than 1 billion doses of product were manufactured.
manufacturing track-record with many products optimised and
manufactured for clients in multiple territories.
The facility has an equipped annual capacity of 2 billion solid oral
doses. The Athlone site is an FDA/EMA-inspected facility.
To contact us please e-mail: edtqueries@elan.com
www.elandrugtechnologies.com