Bio/Pharmaceutical Analysis Techniques

Laboratory Equipment and Instruments

Analytics

Data and Artificial Intelligence

Inhalation Drugs

Parenterals and Injectables

Solid/Semi-Solid Dosage

Specialty Dosage Drugs

Dosage Forms

APIs and Excipients

Formulation and Drug Delivery

Ingredients

Intellectual Property and Patents

Process and Scaling

Drug Development

Aseptic/Sterile Processing

Equipment

Manufacturing, Biologic Drugs

Manufacturing, Biosimilars and Biobetters

Manufacturing, Cell Therapies

Manufacturing, Gene Therapies

Manufacturing, Inhalation Drugs

Manufacturing, Parenterals and Injectables

Manufacturing, Solid and Semi-Solid Dosage Drugs

Packaging and Distribution

Process and Automation

Supply Chain

Manufacturing

Contract Analytical Services

Contract Development Services

Contract Manufacturing Services

Contract Research Services

Logistics and Distribution

Regulatory Consulting

Outsourcing

Ask the Expert

Quality Assurance/Quality Control

Regulatory Oversight and Compliance

Quality Systems

News

Business

Bio/Pharma Business

All News

Bio/Pharma News

Publications

All Publications

PharmTech

PharmTech Europe

Resources

Marketplace

ICH Q9 Revision: A Comprehensive Resource on Quality Risk Management

Peer-Reviewed Research

PharmTech Products

Pharma Insights

Whitepapers

Webcasts

Multimedia

All Videos

Behind The Headlines

Buy, Sell, Hold

Drug Digest Videos

Drug Solutions Podcast

Peer Exchange

Sexy Science

Tech Talk

Conference

Conference Coverage

Conference Listing

Events

Subscribe

Pharmaceutical Technology serves as the connection to bio manufacturing and development, featuring regulatory updates and expert industry news.

About Us

Advertise

Contact Us

Editorial Info

Editorial Advisory Board

Do Not Sell My Personal Information

Privacy Policy

Terms and Conditions

Pharmaceutical Technology - Pharma News and Development Insights

Twitter

LinkedIn

Spotlight

Topic

COVID-19 Update

APIs

Analytical Method Development

Aseptic Processing

Biologic Drugs

Drug Delivery

Excipients

Formulation

Packaging

Process Control/PAT

Process Development

QA/QC

Regulatory Action

1rem

PR agencies perspectives lightening round: buy/hold/sell on mRNA beyond Vaccines, Organ on a chip, Artificial Intelligence (AI) and Machine learning (ML), Viral Vector Yield Improvements, Quality Management Maturity (QMM), Near Patient Manufacturing. The role of a PR agency dissected: are you a coach, a resource, a creative inspiration, a connector, a battering ram, secret sauce, an authoritative stakeholder, experienced guide? How has getting a message out has changed in the last 5 -10 years for pharmaceutical companies. What pharma industry trends do you see as important and want to emphasize, or are simply excited by?

Debra Harrsch, President and CEO, Brandwidth Solutions

Brandwidth Solutions’ holistic approach to scalable, science-focused, and customized marketing starts with in-depth industry knowledge and the full scope of services that enable you to get where you need to go. We speak science®.

Beth Willers, Principal, White Matter Communications

WMC was built to deliver a different type of agency experience to the B2B Life Sciences mark.et. Our focus is on developing quality content while building good habits across the PESO spectrum and making deeper connections both internally and externally to sustain a healthy brand evolution.

Kevin McCarthy, Senior Consultant, Orientation Marketing

Orientation Marketing is a life science and pharmaceutical marketing agency operating within specialist B2B scientific sectors. We help drug, ingredients, packaging, medical technology, contract manufacturing, development and research organisations uncover marketing opportunities to become visible, increase engagement and generate more leads.

 presents the Drug Solutions podcast, where the editors will chat with industry experts from across the pharmaceutical and biopharmaceutical supply chain. Join us as experts share insights into your biggest questions—from the technologies, to strategies, to regulations related to the development and manufacture of drug products.

Podcasts

Public relations agencies dissect pharmaceutical trends: Brandwidth Solutions, Orientation Marketing and White Matter Communications

Drug Solutions Podcast: Pharma Trends Dissected by 3 PR Agency Luminaries

How can organizations determine when to outsource vs. insource? What factors can (or should) be considered? The right outsourcing strategy has the potential to limit unnecessary costs, maintain output and turnaround times, and enable continued flexibility. In part two of this outsourcing series, Meg Rivers and Jeff Henderson, key account manager of Vetter, discuss:

What the biopharma industry currently tends to outsource

Outsourcing strategies the biopharma industry should be utilizing

Internal tasks the biopharma industry should consider outsourcing more in development and manufacturing

What the biopharma industry should reconsider outsourcing and instead perform in-house

What organizations are choosing not to outsource and why

Jeff Henderson, key account manager, Vetter:

 Henderson has served in a variety of positions as an engineer, consultant, and business development professional over the span of his 25-year career. He began his engineering and consulting role with Barry-Wehmiller Design Group in St. Louis, designing, installing, and validating filling and packaging lines for the food, beverage, and pharma industries before earning his MBA at Pepperdine University in Malibu, CA. After that, Henderson worked at Amgen where he was initially responsible for managing contract manufacturing operations at various packaging and sterile fill/finish sites in the United States. He later moved into a more strategic role in developing manufacturing strategies for clinical and commercial products in Amgen’s pipeline. In 2007, he moved to Seattle to focus on downstream efforts in automated warehousing and material handling before returning to a biotech engineering role at Medimmune’s pilot plant in Gaithersburg, MD. Following his position at MedImmune, he joined Vetter as a key account manager in 2010 and has been growing a solid business footprint over the past 12 years.

Listen to part one of this outsourcing series.

In this episode of the Drug Solutions Podcast, Meg Rivers discusses outsourcing strategies in biopharma with Jeff Henderson, key account manager of Vetter.

Drug Solutions Podcast: Outsourcing vs. Insourcing in Biopharma: Determining the Best Strategy: Part 2

FDA mentioned QMM in its 2019 report, Drug Shortages: Root Causes and Potential Solutions, which pointed to a lack of manufacturer incentives to improve their quality management beyond the minimum required for current good manufacturing practice (CGMP) compliance. In this podcast learn what QMM is, and how far beyond GMP functions QMM will drill into, and what accountability senior management bears for sustaining a corporate quality management culture, from an interview with executives at Shabas Solutions LLC, who ran the overseas pilot program.

, Senior Associate, Shabbas Solutions LLC

, Senior Consultant, Shabbas Solutions LLC

, Advisor, Quality and Corporate Compliance, Shabbas Solutions LLC

Shabas Solutions provides Bio-Medical Scientific and Technical Services, Management Advisory Services, Medical Logistics and Supply Chain Management Support, Financial Management Support, Technology Integration, and Training, and Communication and Outreach to Federal Government Agencies. We are recognized for successfully leading large scale, departmental level mission-support operations through our expertise in policy, operations, and systems. As a scientific services provider we offer pharmaceutical consulting across the full lifecycle – drug discovery and development (small molecules and biologics), pharmaceutical manufacturing quality management maturity (QMM), pharmaceutical products storage and distribution, and regulatory affairs. As a responsible contractor, we maintain an ISO 9001:2015 certified quality management system and a DCAA-approved accounting system.

In this episode of the Drug Solutions Podcast, Chris Spivey interviews executives at Shabas Solutions LLC, who ran the overseas QMM pilot project.

Drug Solutions Podcast: FDA Quality Management Maturity (QMM) Overseas Pilot Program Findings: Going Beyond the Regulations

In what instances should organizations outsource vs. insource? Determining the right outsourcing strategy is key to limit unnecessary costs, maintain output and turnaround times, and enable continued flexibility. In part one of this outsourcing series, Meg Rivers, senior editor, and John Koleng, VP of product development and manufacturing for TFF Pharmaceuticals, discuss:

Curia is a global contract research, development, and manufacturing organization offering products and services across the drug development spectrum to help their partners turn ideas into real-world impact—from curiosity to cure.

John Koleng, PhD, VP of Product Development and Manufacturing, TFF Pharmaceuticals:

 Koleng has co-founded several life sciences development and industrialization consultancies focused on product development, manufacturing, scale up, commercialization, and supply chain management. He has more than 20 years of experience in the pharmaceutical industry, including more than 10 years as a consultant. Koleng has been a founding member of three drug development companies that are actively developing new products. He has a diverse range of drug development experience from formulation to route of administration. He has published numerous scientific research articles and is an inventor on 16 issued US patents and pending patent applications. Koleng has worked with TFF Pharmaceuticals as a consultant and is an inventor on several provisional patent applications filed on behalf of TFF. Prior to his consulting career, Koleng was a founding member and served in various roles at PharmaForm before the company was sold to Akela Pharma, Inc. in 2007. John Koleng, Ph.D., R.Ph., VP of Product Development and Manufacturing at TFF Pharmaceuticals has a BS degree in Pharmacy (1994), and a PhD in Pharmaceutics (2002), both from the University of Texas at Austin where he currently holds an adjunct assistant professor of pharmaceutics appointment and serves on the UT College of Pharmacy Dean’s Advisory Council. He is a registered pharmacist.

In this episode of the Drug Solutions Podcast, John Koleng, VP of product development and manufacturing for TFF Pharmaceuticals shares outsourcing strategies in biopharma.

Drug Solutions Podcast: Outsourcing vs. Insourcing in Biopharma: Determining the Best Strategy: Part 1

In this discussion, Feliza Mirasol, science editor for 

, explores innovative approaches, such as plant-made pharmaceutical manufacturing technology and organ-on-a-chip technology, that have been successful in enabling the development and manufacturing scale-up of biologics as well as some emerging therapies. Mirasol also discusses industry challenges, including cost considerations and development timelines, with Barry Holtz, PhD, Chief Scientific Officer of Phylloceuticals, and Professor Yaakov Nahmias, founder and chief scientific officer, Tissue Dynamics and founder and president, Future Meat Technologies.

In this episode of the Drug Solutions Podcast, Feliza Mirasol, Pharmaceutical Technology’s science editor, discusses technologies enabling biologics and emerging therapies manufacturing and development with Barry Holtz, PhD, chief scientific officer of Phylloceuticals, and Professor Yaakov Nahmias, founder and chief scientific officer, Tissue Dynamics and founder and president, Future Meat Technologies.



Drug Solutions Podcast: Biologic Drug Development and Manufacturing

In this episode of the Drug Solutions Podcast, Meg Rivers, senior editor, interviews Joy Aho, senior product manager at Be The Match BioTherapies, about sourcing autologous and allogeneic cell therapies, including discussions on:

Current sourcing options for biopharma companies in the cell therapy space

Key considerations when deciding what sourcing method is best for an individual therapy

Considerations for donor identification and cell collection

Potential collection network strategies for cell therapy, and how these strategies impact quality, agility, and scalability

Vendors for cell therapy and supply chain impacts

Joy Aho, PhD, is the senior product manager at Be The Match BioTherapies, where she develops innovative products and services for the cell and gene therapy industry.

In this episode of the Drug Solutions Podcast, Meg Rivers, senior editor, interviews Joy Aho, senior product manager at Be The Match BioTherapies, about sourcing autologous and allogeneic cell therapies.

Drug Solutions Podcast: Sourcing Autologous and Allogeneic Cell Therapies

In this episode, Chris Spivey, Editorial Director, and Meg Rivers, Senior Editor, interview industry experts to discuss 2022 trends along with a few trends that emerged in 2021, specifically:

The demand for US-based suppliers in 2022

Ensuring resources in the supply chain, including collaborations with competitors

Sustainability in APIs; API and drug product interface; API and excipient trends

Yvonne Duckworth, Automation Engineer, CRB

Cary Martin, VP of Marketing, August Bioservices

Gabe Longoria, Chief Commercial Officer, Astrea Bioseparations

Merrilee Whitney, Head of Biocontinuum Platform, MilliporeSigma (the Life Science business of Merck KGaA, Darmstadt, Germany)

Helen Anderson, Commercial Lead, USA, Aspen

San Kiang, CTO, Porton Pharmatech/J-Star Research

Anil Kane, Global Head of Technical Scientific Affairs, Pharma Services, Thermo Fisher Scientific

Matthias Bucerius, Head of Actives and Formulation, MilliporeSigma (the Life Science business of Merck KGaA, Darmstadt, Germany)

Jeff Woodhead, Senior Scientist, Simulations Plus

Gregory Lane, PhD, Senior Research Investigator, Bristol Myers Squibb

In this episode of the Drug Solutions podcast, Chris Spivey, editorial director, and Meg Rivers, senior editor, interview experts on up-and-coming 2022 trends in the bio/pharma industry.

Drug Solutions Podcast: 2022 Bio/pharma Trends: US-Based Suppliers, Digitization, and Sustainability

Global scale-up requires developing replicable processes that work the same no matter where they are performed. This can be accomplished with smart factories that utilize fully automated manufacturing platforms.

Ushering in Industry 4.0 with the IDMO Model to Solve the CGT Manufacturing Bottleneck

On April 14, 2025, the Trump Administration launched a national security-driven investigation into pharmaceuticals, a move that will likely result in tariffs being placed on pharmaceutical drugs, ingredients, and other components that are imported from outside of the United States. 

Pharmaceutical Tariffs Are Imminent: How Industry is Bracing for Impact

Contract manufacturers have special expertise in the characterization and validation of biopharmaceutical manufacturing processes.

Characterization and Qualification of Processes

Sponsor companies and contract development and manufacturing companies must ensure that the suppliers they use are following sustainability guidelines to truly produce ‘green’ products.

Supplying Sustainably

Contractors are working with sponsor companies to establish and maintain sustainable manufacturing practices in pharma.

Contract Development Services

Latest News