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Is The U.S. Ready For A Re-shored Pharma Supply Chain?

In the first part of this two-part article, we looked at how dependent the U.S. pharmaceutical supply chain is on critical ingredients produced in China and India and the risk that could pose to the nation’s drug supply. In this article, we will examine potential solutions to mitigate those risks and ensure the nation’s drug supply is secure.

EDITOR'S DESK

Securing Biotech Funding When Economies Get Wild
There’s disruption on the startup biotech money trail. Navigating it requires a pliable strategy. Here, multi-time founder and investor Bert Liang shares insight on raising funds during volatile times.

A New Cost Paradigm For CAR Cell Therapies?

Hear from Acepodia CEO Sonny Hsiao about his company's claims that its proprietary approach to conjugating novel natural killer cells could reduce the cost of cellular therapeutics.

View From Tokyo: Rise Of The “Values” Chain

The Wuhan coronavirus outbreak has brokered a virulent "value" chain debate around the world, including a global CDMO's CEO situated in Tokyo.

The Real Threat To Biopharma Supply Chains: Bioprocessing Materials

The COVID-19 induced risk to biopharma is not a shortage of pharmaceutical ingredients. It’s the constricting supply of consumable materials and equipment necessary to produce therapies from them. Mike Piccarreta, Partner at Kearney, offers an outlook and practical advice on supply stabilization in this BioProcess Online exclusive.

ILC Therapeutics’ Interferon Alpha 14 Joins The COVID-19 Fight

The Glasgow-based emerging biopharma recently tapped veteran biotech leader Alan Walker as CEO as it moves ahead with two therapeutic candidates, an rIFN alpha14 focused on early-stage COVID-19 infection and a tick-derived Evasin targeting late-stage COVID-19 ARDS patients.

GUEST COLUMNISTS

A Brief History Of Parenteral Process Validation — How We Got Here
Process validation has been at the center of attention of regulators and parenteral industry practitioners for years — more than 40 years to be exact. This article will look at how process validation evolved to become the primary means of ensuring consistent, high-quality production of parenterals.
Are We Adequately Assessing U.S. Pharma Supply Chain Risks?
There are gaps in our country’s collective knowledge required to determine the severity of the current pandemic’s risk to our supply chain for drugs. Undoubtedly, these gaps will remain, leaving questions that need to be answered and will, hopefully, serve as a road map for legislators and advocates of the industry.
Key Engineering & Facility Considerations For Liposome Manufacturing
This, the second installment in a series, covers factors in installing a liposome manufacturing process in a facility and the engineering points to consider in doing so.
Old Drug, New Tricks? How The BPCIA Could Increase Generic Competition For Insulins
High demand, few suppliers, and soaring prices point to the need for more generic competition in the insulin market. This article discusses recent changes to the legal and regulatory framework governing insulin approval that might facilitate such entry.
Top 5 Mistakes To Avoid When Measuring Overall Equipment Effectiveness
Despite its (apparently) trivial formulation, overall equipment effectiveness (OEE) is one of the most misleading key performance indicators ever used in the manufacturing world. This article examines five common mistakes you'll want to avoid when dealing with OEE.
4 Preparatory Moves For A Post-COVID World
While we don’t know how different the post-COVID world will be, we do know that pharma and medtech leaders are looking ahead and planning to work differently.
Merck, Walmart, IBM, & KPMG’s FDA Blockchain Pilot: What We Learned
IBM, KPMG, Merck & Co., and Walmart successfully completed an FDA pilot program that demonstrated how blockchain technology can be used to help meet the Drug Supply Chain Security Act (DSCSA) requirements to verify, track, and trace prescription medicines and vaccines distributed within the U.S.
A Real-World Consulting Calamity — 6 Ways It Could Have Been Avoided
Some leaders in the pharma, biopharma, and med device industries believe hiring consultants is quicker and more efficient than hiring a full-time employee. Does this thinking fail to factor in the investment required for thorough recruiting and training to ensure a successful engagement?

BIOPROCESSING WHITE PAPERS

Off-Site Storage Of Biological Specimens And Biologics For Risk Mitigation
Choosing an offsite storage facility means asking the right questions to determine if the storage provider has the appropriate risk mitigation infrastructure in place, beginning with a realistic threat assessment.

Industry Trends Changing Sterile Filtration
To help meet the needs of both large- and small-scale operations, suppliers of sterilizing-grade filters have developed new products and technologies to help meet the needs of today’s biomanufacturing processes. Industry trends toward intensified processing and increased implementation of single-use systems are changing approaches to sterile filtration and bioburden control in biomanufacturing processes.
What Clinical Teams Should Know About The Benefits Of Auto-Injectors
For a host of reasons, auto-injectors are becoming biopharma companies’ delivery method of choice for commercial use and late-stage clinical trials. Auto-injectors ensure that the prescribed dose of medication is delivered fully and completely,making it easier to track compliance in clinical trials.
How To Reduce The Complexity Of Custom Single-Use Assemblies
What started out as a simple bag for holding buffers or cleaning solutions has evolved to thousands of single-use products and entire processes. The industry is now calling for standardization.
Got Data? Using Informatics To Protect And Improve Your Business
Life science companies are now seeing the benefits from informatics in the manufacturing side of the business. Are you ready to use data and analytics to improve decision making? There are things you can do now to get started.
Development Pathways For ATMPs: Virus Safety Challenges And Regulatory Perspective
There is an increased risk of viral contamination in settings where ATMPs are prepared, making it critical to understand the contamination risks and the solutions available to control them.

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BIOPROCESSING APP NOTES & CASE STUDIES

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NEWSLETTER ARCHIVE

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BIOPROCESS ONLINE CONTENT COLLECTIONS

19_09_BPO_NextBiotechFacilityEbook_300x200

Designing biopharma production systems and facilities presents daily challenges, given dynamic variables like diverse processes, product frailties, space constraints, and more. This ebook covers the major aspects of the facility engineering “puzzle,” while offering some of the “how to” you’ll need to solve it.