This week’s headlines include: Drugmaker to donate HIV-prevention pills for as many as 200,000 people, Novartis gets approval to sell Kymriah in Japan for $306,000, Boehringer buckles in AbbVie patent fight, saving Humira from biosims until 2023, Interchangeable Biosimilars: FDA Finalizes Guidance, and One of Bay Area’s largest manufacturers is about to get bigger.

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

Next Generation Cell Viability Analyzer Vi-CELL BLU Cell Simplifies and Speeds Workflow

Beckman Coulter Life Sciences just launched its next generation cell viability analyzer, Vi-CELL BLU. As part of the launch, Lena Lee, Global Product Manager for Vi-CELL was interviewed about improvements over the legacy analyzer. The Vi-CELL has been helping researchers for over 20 years to monitor the health of their cells by providing total cell concentration, percent cell viability, and cell size (another indicator of cell health)…

Minimize Cell Culture Contamination and Batch Failure by Creating a Closed System for Cell Culture Expansion

Batch failure due to cell culture contamination is a serious consideration for biomanufacturing. A recent BioPlan Associates Survey examined the frequency, cost and leading causes of batch failure. They found that on average a failure occurs every 9.4 months and costs companies $1 to $2 million. The leading causes of batch failure were contamination and operator error. It is logical that anytime the cell culture system is open, for instance when opening flasks during cell expansion, there is an opportunity for contamination…

End-to-End Integrated Manufacturing Solutions Enable Gene Therapy Commercialization

The past decade has seen a surge in the development of gene therapies. Currently there are over 1,000 cell and gene therapy clinical trials underway worldwide.¹ While the majority of current trials are still in Phase I or Phase II, there are more than 90 trials in Phase III. In fact, at last year’s BIO International Convention, Scott Gottlieb, Commissioner of the US Food and Drug Administration (FDA) stated that he expects the FDA to approve 40 gene therapies by 2022.²…

Biologic Products DNA to IND Timeline in 9 Months – Yes it can be done!

The ability to rapidly develop biologic products from conception to human clinical trials is an increasingly important aspect of controlling drug development costs and in expediting the drug’s pathway to one day provide critical treatments. Hence, there has been an increased focus on ways to shorten the timeline through product development. These expedited timelines are especially important when dealing with infectious disease control…

Using cell culture models of endocrine resistance to improve triple positive breast cancer treatment options

Gibco Cell Culture Hero, Dr. Hillary Stires discusses her work researching better treatment options for triple positive breast cancer patients. She explains how the use of cell culture modeling helps drive her research. She also talks about her experience as a cell culture hero and her passion for the scicomm movement on social media platforms…

Cool Tool – Innovative sorbents enable a robust and streamlined protein purification process

Monoclonal antibodies have long been purified using a platform approach. This platform mainly consists of three chromatography steps. These include a Protein A based affinity chromatography step followed by polishing steps. The purpose of the affinity chromatography is to capture the mAb, while the polishing steps remove any remaining impurities, such as residual DNA, host cell proteins, viruses and aggregates. There are options in the selected polishing steps, but often they involve cation exchange or hydrophobic interaction. Increasingly membrane chromatography is being used as a polishing step to remove any remaining contaminants…

Optimizing mAb Purification with Highly Selective Mixed-mode Cation Exchange Sorbent

In today’s market, mAbs are produced for several therapeutic applications, yet they are not a homogeneous family of products. Each mAb is unique, based on its isoelectric point, hydrophobicity and ability to aggregate; the contaminant HCP content is also process-dependent. As drug manufacturers seek to produce mAbs for various application, they are also looking to streamline processes for efficiency and quality…

Scalable Protein A Chromatography for High-Throughput Process Development

Process development is a critical part of biomanufacturing, but it can be very time and resource intensive. With recent industry initiatives around speed to market, process development is an area that could really benefit from high throughput solutions. One high-throughput process development tool for chromatography is the use of 96-well plates. These plate platforms permit automated screening of large numbers of conditions very efficiently and use only a small amount of material for testing. This platform is great for screening but requires bridging experiments to translate results to process scale. In addition, automating the 96-well process requires investment in liquid handling equipment in order to reach the full potential of the platform…

Utilizing High-Throughput Process Development Tools to Create a Purification Process for a Biosimilar Molecule

Biosimilar molecules have some unique manufacturing requirements that must be taken into account when planning process development. The requirements for process development typically require a good deal of selectivity, cost-efficiency and the need to meet aggressive timelines. These lend themselves to a process development approach that incorporates high throughput…

Designing a Viral Clearance Study – A Step by Step Tutorial

Viral clearance testing is a regulatory requirement and critical part of the overall approval process for all biologics. Viral clearance testing is performed at two points in biologics development. Before Phase I clinical trials, viral clearance studies are conducted to demonstrate the capability of a downstream purification process to eliminate potential viral contaminants…

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Professional Training:

Continuous Downstream Processing

Biofactory Competence Center, Fribourg, Switzerland, May 21-23, 2019

This 3-day training course will provide an introduction to continuous down-stream processing with hands-on practical and theory in process development and bio-manufacturing. It will give an introduction to different available technologies for continuous cell-separation, ultrafiltration, diafiltration and chromatography. The principles on process-integration, quality-by-design, scale-up and economic considerations for continuous processing will be discussed.

Headlines:

“Drugmaker to donate HIV-prevention pills for as many as 200,000 people,” The Washington Post

“The pharmaceutical company that makes a once-a-day pill that protects users against HIV has agreed to donate enough medication to cover as many as 200,000 people for 11 years, the Trump administration announced Thursday…”

“Novartis gets approval to sell Kymriah in Japan for $306,000,” Reuters

“A Japanese government panel approved on Wednesday a price of 33.5 million yen ($305,800) for Novartis’ cancer treatment Kymriah, allowing the Swiss drugmaker to press ahead with a campaign to kick-start sluggish sales of the treatment…”

“Boehringer buckles in AbbVie patent fight, saving Humira from biosims until 2023,” FiercePharma

“Boehringer Ingelheim fought hard against AbbVie’s so-called “patent thicket” surrounding the world’s bestselling med, Humira. But in the end, the German company ended up settling, just like its fellow biosimilar makers. With a Tuesday agreement, Boehringer joins a herd of companies who’ve agreed to sideline their Humira biosims until 2023…”

“Interchangeable Biosimilars: FDA Finalizes Guidance,” Regulatory Focus

“The US Food and Drug Administration (FDA) on Friday finalized a long-awaited guidance spelling out how biosimilars can achieve an interchangeable status, which means they may be substituted for the reference biologic without a prescriber intervening…”

“One of Bay Area’s largest manufacturers is about to get bigger,” San Francisco Chronicle

“Pharmaceutical giant Bayer announced Thursday that it will build a $150 million facility in Berkeley, site of the company’s biotech research and development operations, to develop drugs for cancer, cardiovascular and other diseases…”