Newsletter | February 10, 2020

02.10.20 -- Are You Prepared For Impending Changes To U.S. Biologics & Biosimilars Law?

  The Path To Confidence At Every Point Of Connection

Single-use technology (SUT) has transformed biopharmaceutical development and manufacturing. SUT bioreactors reduce manufacturing costs and offer streamlined production for small batches — a growing trend that makes targeted drug development for specific patient populations possible.

Read more about the path to confidence at every point of connection:
How To Overcome Validation Challenges In A Single-Use World
Single-Use Systems For Storing And Shipping Frozen Drug Materials: Every Component Counts
Extractables Testing On Single-Use Connectors
How Genderless Sterile Connectors Lead To More Flexibility, Faster Changeovers, And Reduced Costs

Featured Editorial
Prepared For Impending Changes To U.S. Biologics And Biosimilars Law?
By Kate Cook, Greenleaf Health

Sponsors for insulins and other protein products originally submitted for premarket review under an NDA may be anticipating the arrival of March 23, 2020, with trepidation. On that date, the BPCIA requires that those NDA-approved products will be deemed to have a BLA (biologics license application) approval instead of an NDA approval.

Biosimilar Litigation Review: Ongoing BPCIA District Court Cases To Watch
By Philip Chen, Felix Eyzaguirre, Tasha Francis, and Jenny Shmuel, Fish & Richardson P.C.

Biosimilars Price Competition and Innovation Act (BPCIA) litigants and federal and district courts grappled with new issues in 2019. In Part 1 of this article series, we summarize BPCIA district court litigation and review ongoing court cases.

Industry Insights
The Rise In Single-Use Instrumentation Options In Bioprocessing
Article | By Brandon Haschke, Emerson

Adoption of single-use manufacturing methods for biopharma processes is a growing trend due to its flexibility and comparatively low capital cost commitment compared to fixed systems.

A Biosafety Revolution
Article | By Afshin Sohrabi, Martin Wisher, and Audrey Chang, MilliporeSigma Process Solutions

Biopharma manufacturers have been using the same assays for viral safety testing for decades, but new analytical technologies and molecular approaches offer a faster and more reliable approach.

Demystifying Extractables Testing
White Paper | By N. Morley, Hall Analytical, and G. Proctor, Parker Bioscience Filtration

It's critical that anyone utilizing single-use technology understands the differences between the various guidances available for extractables analysis and which testing approaches are suited to the study goals.

Current Perspectives On Biosimilars
White Paper | By F. Agbogbo, D. Ecker, et al., Cytovance Biologics

Biosimilars typically have a shorter timeline for approval and can be developed at 20 percent the cost of the innovator. This paper covers the quality management system required for traceable, trackable data. 

Flow Chemistry vs. Batch Processes
White Paper | GVK Biosciences

Batch processing of new chemicals requires versatile, qualified equipment to perform different unit operations. Continuous flow chemistry is emerging as an effective chemical synthesis tool.

Decision Timeline: Considerations In Selecting An Outsourced Solution
Article | Thermo Fisher Scientific

The traditional business model for in-house pharma manufacturing is nearly a thing of the past. More companies are turning to outsourcing to achieve flexibility and efficiency in a highly competitive market. 

Converting From ELISA To Biacore SPR Assays
Application Note | GE Healthcare Life Sciences

This article provides general guidance on how to convert an existing ELISA assay to a Biacore SPR assay and, by doing so, shows how you can get results in less than half the time compared with ELISA.

Exploring The Benefits Of Modular Chromatography Technology
Application Note | JSR Life Sciences

This application note details bed integrity testing of some resins recently packed in Chromassette devices prior to shipment to end users.

Why Are Lipid Formulations Commonly Used To Enhance Bioavailability?
Webinar | Thermo Fisher Scientific

A discussion on potential mechanisms of increased absorption with lipid formulations, screening tools used during the development of these formulations, scale-up, and industrialization considerations. 

  Webinar: 2019 Year In Review

ISR is a market research firm operating exclusively in the pharmaceutical manufacturing and clinical research space. In 2019 they conducted approximately two dozen individual pieces of market research for syndication. This webinar will summarize many of the important learnings from these projects, providing attendees with real, usable data for 2020 activities.

3D Productainer BPC Systems
Thermo Fisher Scientific
Novel Affinity Tag System For Animal Host Cells: PA Tag
FUJIFILM Wako Chemicals U.S.A. Corp.
Recombinant Antigens And Antibodies For Immunoassay Applications
Grifols Recombinant Protein CDMO Services
Life Science Leader Magazine

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Check it out today for access to candid interviews with top-tier executives on how they do business.



ISR Reports is a full-service market research company and sister company of Pharmaceutical Online. Operating exclusively in the pharmaceutical and pharmaceutical services industry, their syndicated and custom market research capabilities enable their customers to make smarter, more informed business decisions.


Topics include: manufacturing practices and models, trends and technology, commercialization, dosage forms, excipients, outsourcing strategies, and more.


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