Where will the future of manufacturing lead us?
Angie Drakulich
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From time to time, it's important to take stock of the industry from both a retrospective and prospective point of view. Throughout
2012, we celebrated 35 years of Pharmaceutical Technology, looking back at major advancements in technology, drug development and manufacturing approaches, and regulatory science.
As we enter 2013, we are eager to envision what the future of bio/pharmaceutical manufacturing will bring. In this issue,
in fact, a special report focuses on emerging regulatory trends, including new FDA approaches to drug reviews and inspections.
You also will find a few new looks across PharmTech's pages, redesigned to address our growing industry coverage as well as
to introduce you to our digital platforms.
But getting back to science and manufacturing, we've asked our editorial advisory board members to provide their perspective
on the future of bio/pharmaceutical manufacturing. Below are a few highlights.
"I believe that more companies will turn to continuous manufacturing. Continuous manufacturing allows companies to manufacture
the desired dosage form in less time as well as the desired amount of drug product reducing inventory costs. Continuous manufacturing
equipment can be installed in less space, thereby reducing energy and maintenance costs. QbD and PAT concepts can be incorporated
within the process, reducing regulatory risks at the same time that financial benefits increase." —Rodolfo J. Romañach, Recinto Universitario de Mayaguez, Puerto Rico
"Pharmaceutical manufacturing has to become more efficient, more sustainable, 'greener' and safer for the patient. New technologies
such as PAT and continuous manufacturing (with on-line quality assurance and real-time release) will help to develop products
and processes according to the QbD principles and achieve these goals." —Griet Van Vaerenberg, GEA Pharma Systems
"The future of pharmaceutical manufacturing must nor resemble its past. Automation has changed the face of much of our society
in the past 20 years, however the industry is somewhat paralyzed with respect to applying automation effectively in the manufacturing
environment. The reasons are numerous and can be summed up in a single word: fear. Our industry fears change, 21 CFR Part 11, validation delays, inflexible operation, and more. We don't make cars, electronics, or anything else other than
pharmaceuticals the way we did in 1980, so it's past time to embrace technologies that can make pharmaceutical products faster,
more consistently and of substantially higher quality." —Jim Agalloco, Agalloco & Associates
"The future of pharmaceutical manufacturing lies in outsourcing. Generally, contractors manage plants at much higher utilization
levels than do the multinational pharmaceutical companies, thus reducing unit cost. The divestiture of plants by merged global
pharmaceutical companies to CMOs provides for significant capacity, which is viewed by multinationals as further opportunity
to reduce cost. With the need to reduce costs, networking with contract manufacturers is the future." —Colin Minchom, Hovione
"Manufacturing and distribution—already regarded by regulators as 'one process'—will continue to merge their joint significance
as we strive to create greater supply-chain integrity and provide the protection from falsified medicines that patients demand
from manufacturers. Guidance such as that contained in USP Chapter 1083, the recent pedigree initiatives, and the new European
GMP/GDP regulations will start to close the gaps that we know exist, but there is a long way to go for manufacturers and their
partners." —Tony Wright, Exelsius
"The future for pharma and biotech appears to be in a state of flux. The activities covering R&D and manufacturing are no
exception. The need to 'go global' is no more a concept but a reality. What comes next is finding partners who already have
a global platform. One has to make a careful assessment for short-listing potential partners." —Mak Jawadekar, Consultant
"Biological medicines are a growing proportion of healthcare budgets. Increasing pressures to deliver more cost-effective
therapies mean that the biotech industry needs to continuously modernize to respond effectively to future challenges. With
personalized medicines on the way, innovative manufacturing strategies will be needed to bring manufacturing close to the
patient. Advances in process and analytical technology are required to generate predictive small-scale mimics of processes,
with data processing tools to help elucidate the interactions between multiple variables. Well-characterised processes are
easier to scale up and out, allowing rapid manufacture and deployment of product." —Sharon Grimster on behalf of the BioIndustry Association Manufacturing Advisory Committee.
Angie Drakulich is editorial director of Pharmaceutical Technology.
