All NewsBio/Pharma News
All PublicationsPharmTechPharmTech Europe
MarketplaceICH Q9 Revision: A Comprehensive Resource on Quality Risk ManagementPeer-Reviewed ResearchPharmTech ProductsPharma InsightsSponsored PodcastsSponsored VideosSponsored eBooksWhitepapers
Webcasts
All VideosAsk the ExpertBehind The HeadlinesBuy, Sell, HoldDrug Digest VideosDrug Solutions PodcastPeer ExchangeSexy ScienceTech Talk
Conference CoverageConference ListingEvents
Subscribe
AnalyticsAnalyticsAnalytics
Data and Artificial Intelligence
Dosage FormsDosage FormsDosage FormsDosage FormsDosage Forms
Drug DevelopmentDrug DevelopmentDrug DevelopmentDrug DevelopmentDrug DevelopmentDrug Development
ManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturing
OutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcing
Quality SystemsQuality SystemsQuality SystemsQuality Systems
Spotlight -
  • Analytics
  • Dosage Forms
  • Drug Development
  • Manufacturing
  • Outsourcing
  • Quality Systems
IS1
  • Applied Clinical Trials

  • BioPharm International

  • Cannabis Science and Technology

  • Chromatography Online

  • Nutritional Outlook

  • Pharmaceutical Commerce

  • Pharmaceutical Executive

  • Pharm Tech

  • Spectroscopy Online

  • Turbo Machinery Magazine

AnalyticsAnalyticsAnalytics
Data and Artificial Intelligence
Dosage FormsDosage FormsDosage FormsDosage FormsDosage Forms
Drug DevelopmentDrug DevelopmentDrug DevelopmentDrug DevelopmentDrug DevelopmentDrug Development
ManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturing
OutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcing
Quality SystemsQuality SystemsQuality SystemsQuality Systems
IS1
  • Applied Clinical Trials

  • BioPharm International

  • Cannabis Science and Technology

  • Chromatography Online

  • Nutritional Outlook

  • Pharmaceutical Commerce

  • Pharmaceutical Executive

  • Pharm Tech

  • Spectroscopy Online

  • Turbo Machinery Magazine

    • Webcasts
    • Subscribe
Advertisement

Publication

Article

March 2, 2010

Pharmaceutical Technology

Pharmaceutical Technology-03-02-2010
Volume34
Issue 3

Baxter International's Shaun Newlon on Manufacturing Trends

The vice-president addresses shifts in process and more.

Shaun Newlon

PharmTech: Do you see a new industry trend emerging?

Newlon:

For solutions, I see a trend toward the production of more biologic agents, rather than conventional, chemically synthesized drugs, which translates to a major shift in manufacturing processes. With the higher value of biologic active ingredients, our manufacturing risk of loss increases. We have seen a strategic shift away from traditional economies of scale and high-speed lines toward small batch sizes with the goal of eliminating scrap and minimizing losses. Our manufacturing systems must be designed for more agility instead of our traditional focus on high run rates.

I also see a trend toward greater use of contract manufacturing services. Small biotech firms and large pharmaceutical companies are identifying manufacturing capability gaps or focusing internal assets on research activities, which spurs them to seek outside manufacturing as extensions of their own operations. Contract manufacturing plants must be customer-oriented entities that provide services and deliver products.

PharmTech:

What is the most common demand your clients are currently making of you?

Newlon:

One of our most regular client demands is the concept of available capacity on demand, especially in contract manufacturing. The desire for instant access and instant response has permeated our collective consciousness, and that extends to pharmaceutical manufacturing. We have to recognize immediacy as a customer expectation and design our contracting and planning systems accordingly. Although not always easy to manage, it's a necessary part of our successful business model.

Another request we get is to have greater flexibility in the quality agreements that define and govern our daily operating parameters. It is extremely challenging for two companies, each with different risk profiles, to be comfortable with the particulars of each other's quality systems and make them work in complementary fashions in a strict global regulatory environment. The good news is that people in our industry are passionate about acting responsibly to do what is right for patients.

Articles in this issue

i3_t-660528-1408626637817.jpg
In the Spotlight March 2010
i1-660522-1408626661127.jpg
Time for a Model Upgrade
Report from India
Report from India
frontimagePT-660521-1408626662870.jpg
Navigating the Global Pharmaceutical Supply Chain
i28-660531-1408626624434.jpg
Industry Pipeline
i9_t-660526-1408626644643.gif
Statistically Justifiable Visible Residue Limits
Spherical Crystallization for Lean Solid-Dose Manufacturing (Part 1)
Spherical Crystallization for Lean Solid-Dose Manufacturing (Part 1)
i1-660532-1408626622084.jpg
Consumers Need Access to Lower-Cost Biogenerics
i1-660525-1408626650372.jpg
Uptick or Sustainable Growth?
i1-660527-1408626642039.jpg
Pharma Capsules
Opportunities in the Biosimilars Market
i3-660534-1408626616620.gif
Health IT Promises More Timely Drug Information
Quick Saves and Near Misses
Inside IPEC: Excipient Pedigree as a Supply Chain Tool
i1-660533-1408626619056.jpg
Skinny or Dead

Newsletter

Get the essential updates shaping the future of pharma manufacturing and compliance—subscribe today to Pharmaceutical Technology and never miss a breakthrough.

Subscribe Now!
Related Videos
A global supply chain map, visualizing the complex network of transportation routes and distribution centers | Image Credit: © venusvi - stock.adobe.com
Shortcut from point A to point B | Image Credit: © Olivier Le Moal - stock.adobe.com
Wooden blocks spelling TARIFFS are placed on a map of North America, specifically over the United States and Mexico | Image Credit: © Rokas - stock.adobe.com
Simona Guidi, Associate Director, ProPharma
DC skyline at night with view of the White House and the Washington Monument | Image Credit: © Jessica - stock.adobe.com
Behind the Headlines, Episode 18
Related Content
Advertisement
White House | Image Credit: © Zack Frank - stock.adobe.com
August 2nd 2025

Trump Sends Letters to 17 Leading Pharma Companies Outlining Most-Favored-Nation Drug Pricing Protocol

Patrick Lavery
If action is not taken within 60 days, the White House said it would “deploy every tool in our arsenal” to improve drug pricing practices for American patients.
Drug Solutions Podcast: Growth and Advancements in Fill/Finish
August 2nd 2025

Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Felicity Thomas
In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.
automatic stainless steel pharmaceutical fermenter | Image Credit: ©gen_A - stock.adobe.com
August 2nd 2025

In-line UV Spectrometry Monitoring in Cleaning Validation

John Schallom Brian Bosso Paul Lopolito Katie Frey Amy Thanavaro
The authors performed interference and enhancement testing using a formulated alkaline and acid cleaner, as well as common biopharmaceutical process residues.
Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines
August 2nd 2025

Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines

Feliza Mirasol
In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.
Landkarte *** Europa | Image credit: ©beugdesign - Stock.adobe.com
August 2nd 2025

EMA Encourages Use of New Approach Methodologies to Reduce Animal Testing

Cheryl Barton
EMA is phasing out animal testing and is asking pharmaceutical companies to use new approach methodologies.
medicine factory scientist worker work in Laboratory Plants Process. medical doctor working research in pharmaceutical industry. | Image Credit: ©Quality Stock Arts – stock.adobe.com
August 2nd 2025

Interfering with Interventions in Aseptic Processing

James Agalloco
Addressing human interventions to reduce their impact on contamination requires addressing broader considerations than limiting operator activities. Equipment, automation, procedural and component changes can be utilized to make the aseptic activities safer. This article offers suggestions for reducing the adverse impact of intervention throughout the aseptic process.
Related Content
Advertisement
White House | Image Credit: © Zack Frank - stock.adobe.com
August 2nd 2025

Trump Sends Letters to 17 Leading Pharma Companies Outlining Most-Favored-Nation Drug Pricing Protocol

Patrick Lavery
If action is not taken within 60 days, the White House said it would “deploy every tool in our arsenal” to improve drug pricing practices for American patients.
Drug Solutions Podcast: Growth and Advancements in Fill/Finish
August 2nd 2025

Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Felicity Thomas
In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.
automatic stainless steel pharmaceutical fermenter | Image Credit: ©gen_A - stock.adobe.com
August 2nd 2025

In-line UV Spectrometry Monitoring in Cleaning Validation

John Schallom Brian Bosso Paul Lopolito Katie Frey Amy Thanavaro
The authors performed interference and enhancement testing using a formulated alkaline and acid cleaner, as well as common biopharmaceutical process residues.
Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines
August 2nd 2025

Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines

Feliza Mirasol
In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.
Landkarte *** Europa | Image credit: ©beugdesign - Stock.adobe.com
August 2nd 2025

EMA Encourages Use of New Approach Methodologies to Reduce Animal Testing

Cheryl Barton
EMA is phasing out animal testing and is asking pharmaceutical companies to use new approach methodologies.
medicine factory scientist worker work in Laboratory Plants Process. medical doctor working research in pharmaceutical industry. | Image Credit: ©Quality Stock Arts – stock.adobe.com
August 2nd 2025

Interfering with Interventions in Aseptic Processing

James Agalloco
Addressing human interventions to reduce their impact on contamination requires addressing broader considerations than limiting operator activities. Equipment, automation, procedural and component changes can be utilized to make the aseptic activities safer. This article offers suggestions for reducing the adverse impact of intervention throughout the aseptic process.
About Us
Advertise
Contact Us
Editorial Info
Editorial Advisory Board
Do Not Sell My Personal Information
Privacy Policy
Terms and Conditions
Contact Info

2 Commerce Drive
Cranbury, NJ 08512

609-716-7777

© 2025 MJH Life Sciences

All rights reserved.