beads/pellets being sprayed with active and then coated/
encapsulated; or the use of fixed dose combinations. This
requires specialist knowledge and capabilities in the processes involved.
From a commercial perspective, increasing manufacturing
and packaging complexity is a continued trend. By that I
mean clients are outsourcing products and processes that
require specialist knowledge and equipment. This is leading
to some interesting opportunities in terms of capital investment with clients willing to fund relatively large capital
items to ensure available capacity and access process know
Lastly smaller batch sizes, whether it be for an orphan
drug or a pediatric dosage, is requiring ever more flexible
and versatile processing and packaging solutions, which
suits Almac’s scale of operation perfectly.
What is the best way to manage the expectations of cus-
tomers and maintain a good working relationship?
Callanan: Be open and honest. The use of, and sharing
of, metrics is a good way of maintaining an open and transparent relationship. Being able to collect good and mea-sureable information through our Operational Excellence
programs over the past few years has significantly improved
our communications to our customers. Also establishing
regular meetings where relationships develop are important
– with these, any issues that may rise can be discussed and
solutions reached by consensus. Also having regular face
to face meetings (perhaps annually) helps staff interactions
from both organizations. Communications is key.
Teeter: 1. Take the lead in establishing timelines, deliverables and priorities.
2. Be proactive and consistent in communication with
each customer at all points of contact.
3. Recognize timelines and exceed expectations.
4. Designate a team member with full responsibility for
satisfaction of each customer.
Skultety: The first step is to make sure that both the
customer and you are speaking the same language. For
example, what does each side think that Quality by Design
means and how it is applied to manufacturing. Second is
to sit down and review the goals/timelines of the project.
Communication and transparency are paramount in making
things run smoothly. Both sides must agree upfront that the
Are you seeing any emerging trends in the types of prod-
ucts being manufactured?
Fidelma Callanan, Senior Director, Contract Pharma
Services, Alkermes: Yes, we are seeing many more queries
relating to high potency manufacturing. Approximately 25%
of drugs currently in development highly potent.
Forecasts suggest their increasing therapeutic use will
drive the market for HP products by CAGR 9.9% (2012-18).
Howard Teeter, President, Anteco Pharma: The most
significant trends for Anteco Pharma have been companion
diagnostics and sterile, bulk lyophilized API’s. We are also
seeing more outsourcing of low-mid volume API’s and clinical test systems – the core marketing focus of the company.
Paul Skultety, PhD, Vice President, Pharmaceutical
Development Services: Xcelience: For Phase I studies, the
popularity of the active substance by itself in a capsule shell
continues to grow. This provides more flexibility in the number of strengths that can be manufactured and is the quick-est way to manufacture clinical supplies. There seems to be
a resurgence of companies evaluating combination products.
This is leading to a renewed interest in such technologies as
bi-layered tablets or multiparticulate systems. Both of these
technologies provide an easy way to provide a formulation
that may contain a combination of slow release and instant
release portions of the same active ingredient or for several
active ingredients. We continue to see a large number of
oncology products as extensive research is allowing very
specific targeting of cancer types. There is more and more
interest into how to safely handle and manufacture this category of compounds.
David Downey, VP Commercial Operations, Almac: From
a development perspective, dosages are generally lower,
potency is higher and complexity of the active molecule has
increased. This then leads to certain requirements from a
processing perspective –
1. Containment of highly potent molecules is, in its simplest terms, separating the product from the operators
and limiting manual intervention, ensuring operator safety.
Almac achieves this through the use of isolators around the
processing equipment which have been fabricated in-house
so they are bespoke to the equipment. This allows for enhanced and more cost effective processing capabilities in a
safe operating environment.
2. Formulations are changing whether it be for example,
■ By Mike Auerbach, Editor in Chief
Current trends, critical issues and a glimpse into the future from
manufacturing service providers