This week’s headlines include: FDA Commissioner Gottlieb, who raised alarms about teen vaping, resigns, FDA Accepts Genentech’s Supplemental New Drug Application For Xofluza, Senators tell FDA to speed up approvals of generic insulin, Biogen to buy Nightstar Therapeutics in $800 mln cash deal, and Gilead’s Kite pens 10-target CAR-T tech deal with MaxCyte.

Podcasts:

Check out our podcast channel. We have over 25 great podcasts covering drug discovery, stem cell culture, upstream and downstream biomanufacturing and more! Click below to download from iTunes or Google play:

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

Increased CHO Transfection Efficiency and Production in a Straight Forward System

Transient protein production enables quick and efficient production of milligram to gram quantities of recombinant protein, which saves time and cost compared to developing a genetically stable cell line for use in bioproduction. This is particularly important in drug development where preclinical material is needed quickly in order to make informed go/no go decisions. Having access to preclinical material faster can greatly impact the overall drug development timeline. The challenge has been low transfection efficiency and productivity, particularly in CHO cells. CHO cells are typically more difficult to transfect, but are the preferred vehicle of antibody production due to their use in larger scale production of clinical material…

Keys to successful single-use bioreactor scale up – from small scale to pilot scale

Successful monoclonal antibody (mAb) manufacturing relies on good process development and reliable bioreactor scale up. Initial process development work is typically conducted at small scale, then moved to bench scale and lastly to pilot scale before moving into manufacturing. One of the biggest challenges is scaling up an optimized process from process development to manufacturing scale. Just a small change in the size of the bioreactor can have a cascade effect on many other culture conditions…

Cool Tool – New chemical modification of L-Tyrosine and L-Cysteine increase solubility and stability and permit single feed strategies

A long-standing challenge in the use of amino acids as part of a feed strategy has been the insolubility of tyrosine and the oxidation of cysteine at neutral pH. This has required the use of alkaline feeds to allow solubility and stability. The need for alkaline feeds complicates operations by forcing a multiple feed strategy as all components can’t be fed together…

Enzymes for Cellular Lysis or Protoplast Formation: Bacteria, Yeasts, and Plant

Digesting cell walls using enzymes is a critical component of many scientific approaches such as cellular lysis, proto/spheroplast formation, and numerous other approaches. The use of enzymes has advantages over physical or chemical methods because of its specificity, the use of milder conditions and lower shear stress. Since cell walls differ in composition between types of cells, it is important to use an enzyme with the correct specificity and activity for the application. Other consideration in choosing an enzyme include the purity and need for other reagents or additional procedures related to the use of that particular enzyme…

Integrating bioprocessing steps to improve efficiency and reduce cost

In this podcast, we interviewed Dr. Rick Morris, Senior Vice President, R&D, Biotech, Pall Life Sciences, about integrating bioprocessing steps to improve efficiency, reduce cost and address current challenges in the industry.  Specifically we looked at how upstream and downstream can be more integrated and how to increase integration in existing facilities…

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…

Webinars:

Streamline Your Protein Purification Platform

In this webinar, the benefits of Pall’s chromatography process, which features KANEKA KanCapA^♦, Mustang® Q and CMM HyperCel™ sorbents will be presented with a focus on the specificity of CMM HyperCel sorbent versus traditional cation exchangers or other mixed mode resins. This three-step process can be operated without any need for diafiltration or dilution between the chromatography steps.

Tuesday, March 12^th 2019 at 8:00am GMT /9:00 am CET / 1:30 pm IST / 5:00 pm JST

Register Here

Conferences:

BioProcess International West

March 11-14, 2019
Santa Clara Convention Center, Santa Clara, California, USA

Headlines:

“FDA Commissioner Gottlieb, who raised alarms about teen vaping, resigns,” The Washington Post

“Food and Drug Commissioner Scott Gottlieb, who used his post to tackle difficult public health issues from youth vaping to opioid addiction – surprising early skeptics worried about his drug industry ties – resigned Tuesday, effective in about a month. Gottlieb, who has been commuting weekly to Washington from his home in Connecticut, said he wants to spend more time with his family. The 46-year-old physician, millionaire and cancer survivor known for a self-assured, sometimes brash, manner lives in Westport, with his wife and three daughters – 9-year-old twins and a 5-year-old…”

“FDA Accepts Genentech’s Supplemental New Drug Application For Xofluza,” Reuters

“FDA accepts Genentech’s Supplemental New Drug Application for Xofluza (Baloxavir Marboxil) for the treament of influenza in people at risk of complications…”

“Senators tell FDA to speed up approvals of generic insulin,” The Hill

“A bipartisan group of senators want the Food and Drug Administration (FDA) to change its policy in order to speed up approvals of lower-cost, generic insulin products…”

“Biogen to buy Nightstar Therapeutics in $800 mln cash deal,” Reuters

“Biogen Inc said on Monday it will buy Nightstar Therapeutics Plc for about $800 million in cash as the company looks to tap into a potentially lucrative gene therapy market. Biogen’s offer of $25.50 per share, represents a premium of 68 percent to Nightstar’s Friday close of $15.16…”

“Gilead’s Kite pens 10-target CAR-T tech deal with MaxCyte,” FierceBiotech

“Gilead’s Kite Pharma has expanded its CAR-T agreement with MaxCyte. The revised deal gives Kite the chance to apply MaxCyte’s transfection technology to up to 10 targets. Kite first struck a deal to use MaxCyte’s technology, dubbed Flow Electroporation, in November. Now, Kite has significantly expanded the deal by securing the right to use the technology in the nonviral engineering of CAR-T therapies against up to 10 targets. MaxCyte granted Kite nonexclusive access to the technology in return for a financial package featuring development and approval milestones…”