20 BioPharm International eBook April 2019 www.biopharminternational.com
Outsourcing Resources Manufacturing
Navigating the
Biologics Wave
Contract manufacturing organizations need
to adapt to successfully overcome the specific challenges
posed by complex therapies.
T
he growth within the field of biologics has
been palpable over the past few years and is
expected to continue to expand for the fore-
seeable future. With such a positive outlook,
outsourced capabilities may also be able to
ride on the crest of the biologics wave (1), although
as reported by Results Healthcare, contract manufac-
turing organizations (CMOs) may need to consider
subsector patterns to take advantage of the market
shifts (2).
BioPharm International spoke with Mike Danzi, CEO
of Legacy Pharmaceuticals Switzerland, which is a
SwissMedic and US FDA-approved CMO, about the
challenges facing CMOs in the field of biologics and
best practices for working with complex therapies.
CHALLENGES IN BIOLOGICS
BioPharm: As the number of biologics in development is
rising, could you run through the major challenges that
face CMOs in terms of these complex therapies and the
impact on services required?
Danzi (Legacy Pharmaceuticals): Biologics are indeed
a major trend in our industry. Three challenges that
quickly come to mind are: the API is often extremely
valuable and must be dealt with accordingly—tradi-
tional API losses are not acceptable; secondly, there is
Production
Perig/Stock.Adobe.com
FELICITY THOMAS
