This week’s headlines include: F.D.A. Speeds Review of Gene Therapies, Vowing to Target Rogue Clinics, Boehringer bags first biosimilar approval in the EU, Congress Weighs Repeal of Tax Credit for Rare Disease Drugs, Dynavax’s hepatitis B vaccine gets FDA nod on third try, shares up, Sandoz says new clinical data support two biosimilars, and Genentech doubles down on Arvinas, swelling deal to $650M.

In Case You Missed It, Recent Articles on Cell Culture Dish and Downstream Column:

Organoid Cell Culture – Frequently Asked Questions

We recently finished our Ask the Expert discussion, “Going tiny is the next BIG thing: Tools and Techniques for Organoid Cultures”. During this Ask the Expert session, we covered topics related to the culture of organoids including, media requirements, co-culture with other cells, surface requirements, culture vessels, nutrient delivery and gas exchange, harvesting organoids, and key points on the cell culture process timeline. In addition, we also had questions about making organoid cell culture more high throughput to meet the needs of drug screening, the difference between spheroids and organoids, and best practices for immunostaining of organoids…

Video – Upstream Bioprocessing Cell Culture Overview

An overview of upstream bioprocessing steps beginning with an explanation of molecular biology and cell line engineering, then continuing with creation of a working cell bank, cell expansion, bioreactor production and clarification steps…

FBS – It’s not all created equal – what consumers need to know

In this podcast and accompanying article, we interviewed Alyssa Master, Ph.D., Senior Manager of Science and Applications, Nucleus Biologics about some of the challenges of working with FBS, why not all FBS is created equal and suggestions for FBS customers who are trying to navigate these issues…

Managing Shear Stress in Biomanufacturing with the shear protectant Poloxamer 188 – A Discussion

We recently finished our Ask the Expert discussion, “Ask the Expert – Addressing Shear Stress in Bioreactors”. During this Ask the Expert session, we had questions that covered topics including factors that contribute to shear, analyzing and modeling shear stress in a bioreactor, and how to use a shear protectant to protect against shear. In addition, we had several questions related to Poloxamer 188 implementation, best practices, cell lines, qualification and media concentration level…

Enabling Antibody-drug conjugate manufacturing using single-use systems in downstream – Extractables study demonstrates a good fit

Antibody drug conjugates offer tremendous therapeutic potential and the market for ADCs is expected to expand rapidly. However, antibody-drug conjugate manufacturing presents both technological and logistical challenges…

2017 Biotech Week Boston – Downstream Coverage Highlights

Last month, Boston Biotech Week featured interesting content with a wide range of issues, from cell culture techniques to commercialization and everything in between covered. Talks focused on improving the manufacturing process for biopharmaceuticals and cell therapies, enabled industry networking opportunities, and provided the chance to see the latest products and technologies…

Cool Tool – Optimize downstream processing with single-pass inline concentration

Concentration of biological drug substances is an important step at various stages in biomanufacturing. Concentration is often necessary between chromatography steps, in post harvest, during pre-capture or for in-process volume reduction. Concentration may also be needed between chromatography steps.

During concentration applications, there is a potential for aggregation, particularly with sensitive biologics even when they are only slightly stressed. Therefore, an effective concentration system must operate efficiently under mild conditions while at the same time being flexible enough to integrate readily with different downstream operations…

Cool Tool – ‘Jetting’ technology for manufacturing agarose beads with enhanced performance characteristics

The vast majority of chromatography resins designed for large-scale bioprocess chromatography separation are produced using traditional batch emulsification in conventional stirred-tank reactors. In these cases, the size of the beads formed in the reactor is a function of the shear force generated by the impeller. The faster the impeller speed, the smaller the beads are. As a result, there is a wide particle size distribution of the manufactured beads. Furthermore screening is required to remove coarse and fine beads, which detract from column performance. This screening is extremely time consuming particularly for smaller beads (less than 65 µm). The smaller the bead being produced the lower the achieved yield so realistically one cannot make beads financially viable less than 40 µm. It also adds high costs due to the additional time in the manufacturing facility with large volumes of waste from the fine and coarse beads. Even after this screening, the resin will still have a relatively wide size particle distribution…

Webinar:

Making Virus Inactivation a Reality for Continuous Upscaled Processes

Presented by: David Johnson & Mark Schofield

Date: Thursday, November 30, 2017
Time: 8 am PST / 11 am EST

Date: Tuesday, December 5, 2017
Time: 9 am GMT / 10 am CET/ 2:30 pm IST / 5 pm CST / 6 pm JST

Duration: 1 hour

The Cadence™ Virus Inactivation (VI) system, a fully automated low pH virus inactivation system for both batch and continuous processing is one of the latest additions to Pall’s Continuous platform.  This webinar will discuss how traditional low pH virus inactivation has been translated into an automatic system, and also the additional challenges associated with making it a continuous process.  There will be a review of the two methods used for validating the design and an overview of the integration of capture chromatography and virus inactivation, which represents the first commercial scale combined unit operations in this space.

Events:

November

World Orphan Drug Congress Europe
November 13 – November 15
FAIRMONT REY JUAN CARLOS I, Av. Diagonal, 661-671
BARCELONA, 08028 Spain
The 8th annual World Orphan Drug Congress is the marketplace for orphan drug professionals looking at the complete value chain of orphan drug development, from clinical development and R&D to corporate development and market access.

Headlines:

“F.D.A. Speeds Review of Gene Therapies, Vowing to Target Rogue Clinics,” The New York Times

“The Food and Drug Administration on Thursday issued new guidelines to speed the introduction of treatments involving human cells and tissues, including Gene Therapy. But the agency also said it would crack down on rogue clinics offering dangerous or unproven versions of those treatments…”

“Boehringer bags first biosimilar approval in the EU,” PharmaTimes

“Boehringer Ingelheim has won its first biosimilar approval in Europe with authorisation of Cyltezo for a range of chronic inflammatory conditions, including rheumatoid arthritis, psoriatic arthritis, Crohn’s disease and ulcerative colitis…”

“Congress Weighs Repeal of Tax Credit for Rare Disease Drugs,” The New York Times

“A decades-old tax credit designed to spur cures for rare diseases has been so successful that it’s now become a target in the House Republican tax plan. The proposal under consideration would end the tax breaks for development of what are called orphan drugs. Ending the credit used by big and small drug companies could save the government an estimated $54 billion over the next decade, an effort to help offset some of the anticipated losses in revenue if other Republican tax cut provisions become law.”

“Dynavax’s hepatitis B vaccine gets FDA nod on third try, shares up,” Reuters

“Dynavax Technologies Corp’s hepatitis B vaccine won the U.S. Food and Drug Administration’s approval on the third attempt and Chief Executive Eddie Gray told Reuters the company was open to, but not waiting for, a partner to market the drug…”

“Sandoz says new clinical data support two biosimilars,” Reuters

“Novartis’ generics division, Sandoz, said new immunology data from four clinical studies supported its proposed biosimilars adalimumab for treating psoriasis and cancer drug rituximab…”

“Genentech doubles down on Arvinas, swelling deal to $650M,” FierceBiotech

“Genentech has doubled the size of its alliance with Arvinas, moving the potential value of the pact up above $650 million. The expansion of the deal gives the Roche subsidiary the chance to use Arvinas’ protein degradation technology against additional disease targets…”