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

2014 Manufacturing Trends and Outlook

January 15, 2014
By Rita C. Peters
News
Article

Equipment and Processing Report

Equipment and Processing ReportEquipment and Processing Report-01-15-2014
Volume 0
Issue 0

A survey of BioPharm International readers found that single-use systems and other technologies are driving process efficiencies in biomanufacturing, but there is room for improvement.

Reprinted from BioPharm International, Jan. 2014.

In a recent survey of current trends and practices in biopharmaceutical manufacturing, BioPharm International readers revealed a preference for disposable systems, identified challenges for different therapies, and suggested technology enhancements to improve process efficiencies (1).

Survey respondents represented research, development, formulation, and process development functions, as well as quality control/assurance, validation, and laboratory management titles at branded and generic-drug companies in the United States, Europe, and Asia. More than half of the respondents work for organizations that produce both small- and large-molecule drugs; 25% added a biopharmaceutical-manufacturing program in the past year.

The responses indicate some signs of manufacturing growth. More than half of all respondents said their companies increased biomanufacturing capacity in 2013. Less than 3% reported a drop in production. Only 8.1% said their companies decreased spending for biopharmaceutical equipment and services in 2013 compared to 2012; 37.8% reported increased spending; spending was flat for 33.8% of respondents. Nearly 40% expect spending to increase in 2014 compared to 2013; only 5.4% expect a decrease.

The top reasons for increased capacity were the addition of new products and increased production of existing products. More than 40% of respondents said that internal development of new products spurred the need for additional capacity. About 20% said capacity was added due to the acquisition of another company or in-licensing of a drug product

Almost 45% of the respondents reported that their organizations manufacture therapeutic monoclonal antibodies (mAbs); more than 55% of those surveyed said they manufacture protein-based drugs other than mAbs. More than 40% of the respondents said their companies manufacture vaccines; 17.7% develop cells for tissue and/or cell therapies; 10.4% manufacture nucleic-acid based drugs.

Challenges: Protein-based drugs. Facilities that manufacture protein-based drugs reported use of multiple purification technologies. Ion-exchange chromatography was the most frequently reported (71.6%) followed by chromatography with other resins (62.7%), chromatography with Protein A (56.7%), and membrane-based filters (53.7%).

Protein stability led the list of reported technical challenges, cited by 53.7% of the respondents. Producing sufficiently high product yields was a close second at 52.2%; purifying high product yields was the third most frequently cited at 49.3%. Protein aggregates, formulation issues, creating/cloning cell lines, regulatory issues, and analytics were mentioned by more than 25% of the respondents (see Table I).

Nucleic-acid based drugs. Although they represented a smaller subset of the respondents, those that manufacture nucleic-acid based drugs reported multiple manufacturing challenges. Purification (reported by 45.5%), stability (36.4%), drug delivery (31.8%), and scale up (27.3%) led the list (see Table I).

Cells for tissue or cell-based therapies. Process development for cells for tissue- or cell-based therapies created technical challenges for half of the respondents. Scale up (35.7%), cell viability (31%), and cell stability (28.6%) were also listed as top technical issues. Regulatory issues, costs, analytics, and inadequate bioreactor volumes were other challenges (see Table I).

Protein-based Therapies
% of respondents
Protein stability
53.7%
Producing high enough product yields
52.2%
Purifying high product yields
49.3%
Protein aggregates
41.8%
Creating/cloning cell lines
34.3%
Formulation issues
34.3%
Regulatory
31.3%
Analytics
26.9%
Drug delivery
22.4%
Viral contamination
20.9%
Microbial contamination
19.4%
Achieving accurate folding or other post-translational modifications
17.9%
Finding adequate analytical tools for PAT
17.9%
Creating efficient expression cassettes/plasmids
14.9%
Maintaining working cell lines
14.9%
Maintaining master cell lines
10.4%
Nucleic-acid Therapies
% of respondents
Purification
45.5%
Stability
36.4%
Drug delivery
31.8%
Scale-up
27.3%
Achieving adequate expression levels of product
25.0%
Analytics
25.0%
Automation
22.7%
Formulation
22.7%
Regulatory issues
20.5%
Contamination
15.9%
Cells for Tissue or Cell-based Therapies
% of respondents
Process development
50.0%
Scale up
35.7%
Cell viability
31.0%
Cell stability
28.6%
Analytics
23.8%
Costs
23.8%
Regulatory issues
23.8%
Bioreactor volumes inadequate for the quantities of cells we want to produce
21.4%
Formulation
21.4%
Automation
19.0%
Maintaining cells in proper developmental phase
16.7%
Inadequate surface area to grow adherent cells in large-enough quantities
14.3%
Availability of appropriate cell-culture medium
9.5%

 

Process analytical technologies
More than half of the respondents reported using process analytical technology (PAT) in manufacturing operations. High-performance liquid chromatography was the clear leader, used by 71.7% of those that implement PAT. Use of Fourier transform infrared spectroscopy was reported by 41.3%; almost one-third use near-infrared spectroscopy. More than one-quarter use disposable sensors

Hybrid equipment dominates
Hybrid manufacturing systems, which feature traditional stainless steel and disposable, single-use equipment, were used by almost three-quarters (74.4%) of the respondents; 16.3% use all stainless; 9.5% use all disposable.

All respondents, those who used and did not use disposables, shared perceptions about the value of single-use systems. Nearly 70% cited reduced contamination as an advantage. Time savings, ease of use, and flexibility for multiproduct manufacturing were identified as advantages by more that half of the respondents (Figure 1). While 38.1% said disposables offered cost savings, 55.6% said high cost was a challenge to using a disposable system. Other challenges were limitations on size and leaching of the disposable material into the product (Figure 2).

Quality by Design
Improved process understanding (68.4%), improved product quality (66.7%), and reduced variability in product quality (57.9%) were the top advantages identified by the respondents who have implemented quality-by-design (QbD) principles in their biopharmaceutical manufacturing operations. Nearly half reported improved manufacturing efficiency as a result. However, almost 32% of the respondents have not implemented QbD. Reasons cited for not implementing QbD include a lack of guidance and direction from regulatory agencies (46.2%), no process or quality advantage to be gained (30.8%), a lack of understanding of the QbD initiative (23.2%), or it is too costly.

Past and future innovation
Respondents revealed insight about recent innovations that have improved process efficiencies.  Equipment and products related to disposable systems were most frequently mentioned.

There is, however, room for improvement. Better disposable systems, including bags that do not leak, reduced leaching, larger bioreactors and fermenters, and disposable sensors were identified as desired new technologies to improve process efficiencies. Better filtration, chromatography columns, automation, and process analytical technologies also were identified as ways to improve manufacturing efficiencies.
an Alternative:

Outsourced Manufacturing
Outsourced manufacturing plays a prominent role among the companies represented in the survey. Almost 40% reported outsourcing of some component of biopharmaceutical manufacturing. Leading outsourced function, are drug substance manufacturing, API and finished products manufacturing, and clinical trial-materials manufacturing. More than one-third of the companies outsource full-scale commercial manufacturing. Limited internal manufacturing capabilities and cost-effectiveness were the leading reasons cited for outsourcing different functions in biopharmaceutical manufacturing.

Reference
1. BioPharm International Manufacturing Trends 2014 Survey.

Articles in this issue

EPR0114_Edpick2_Volkmann_150-831972-1408528925137.jpg
Volkmann Introduces Low-Profile Pneumatic Conveyor
EPR0114_Edpick1_Accelrys_150-831971-1408528926886.jpg
Accelrys Materials Studio Enhances Modeling and Simulation
2014 Manufacturing Trends and Outlook
2014 Manufacturing Trends and Outlook
Web_Schmitz_Headshot2-832202-1408528643545.jpg
Selecting Single-Use Systems for Biopharmaceutical Manufacturing
Preparing for Serialization: A Q&A with Packaging Coordinators, Inc.
Recent Videos
Behind the Headlines, Episode 17
Related Content

Gold winners award with three stars | Image Credit: © sergign - stock.adobe.com

ISPE Announces Six 2025 FOYA Category Winners

Patrick Lavery
May 15th 2025
Article

Six winners and two honorable mentions were revealed at ISPE’s Europe Annual Conference in London.


Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Felicity Thomas
June 25th 2024
Podcast

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.


Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - stock.adobe.com

Piramal Pharma to Invest $90 Million at Kentucky & Michigan Sites

Patrick Lavery
May 12th 2025
Article

The company said the investment is in response not only to customer demand and a belief in the value of US-based innovation, but also because of the trend toward US onshoring brought about by new tariff policies.


Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail

Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail

Felicity Thomas
May 28th 2024
Podcast

In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.


Mississauga, On, Canada - October 24, 2020: Astrazeneca Canada company sign is seen in Mississauga, Ontario, Canada. AstraZeneca plc is a British pharmaceutical and biopharmaceutical company. | Image Credit: © JHVEPhoto - stock.adobe.com

EU Approves AstraZeneca Mantle Cell Lymphoma Treatment

Patrick Lavery
May 9th 2025
Article

Calquence (acalabrutinib) plus bendamustine and rituximab reduced risk for disease progression or death by 27% compared with the current standard of care, according to a phase III trial.


Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - © Artur - stock.adobe.com

New CBER Director Appointed

Susan Haigney
May 7th 2025
Article

FDA chooses Dr. Vinay Prasad, MD, MPH, a hematologist-oncologist, to lead the Center for Biologics Evaluation and Research at FDA.

Related Content

Gold winners award with three stars | Image Credit: © sergign - stock.adobe.com

ISPE Announces Six 2025 FOYA Category Winners

Patrick Lavery
May 15th 2025
Article

Six winners and two honorable mentions were revealed at ISPE’s Europe Annual Conference in London.


Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Felicity Thomas
June 25th 2024
Podcast

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.


Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - stock.adobe.com

Piramal Pharma to Invest $90 Million at Kentucky & Michigan Sites

Patrick Lavery
May 12th 2025
Article

The company said the investment is in response not only to customer demand and a belief in the value of US-based innovation, but also because of the trend toward US onshoring brought about by new tariff policies.


Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail

Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail

Felicity Thomas
May 28th 2024
Podcast

In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.


Mississauga, On, Canada - October 24, 2020: Astrazeneca Canada company sign is seen in Mississauga, Ontario, Canada. AstraZeneca plc is a British pharmaceutical and biopharmaceutical company. | Image Credit: © JHVEPhoto - stock.adobe.com

EU Approves AstraZeneca Mantle Cell Lymphoma Treatment

Patrick Lavery
May 9th 2025
Article

Calquence (acalabrutinib) plus bendamustine and rituximab reduced risk for disease progression or death by 27% compared with the current standard of care, according to a phase III trial.


Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - © Artur - stock.adobe.com

New CBER Director Appointed

Susan Haigney
May 7th 2025
Article

FDA chooses Dr. Vinay Prasad, MD, MPH, a hematologist-oncologist, to lead the Center for Biologics Evaluation and Research at FDA.

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.