This week’s headlines include: Speed Path to Approval for Some Gene Therapies, The Thing Inside Your Cells That Might Determine How Long You Live, AstraZeneca opens South San Francisco facility housing 400 R&D staff, House Passes ‘Right-To-Try’ Bill For Experimental Drugs, Drugmakers Call for More Clinical Trial Flexibility in Alzheimer’s Drug Guidance, and Experimental drugs poised for use in Ebola outbreak.

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

Mycoplasma Contamination – Early Detection and Elimination Can Ensure Research Validity

How big of a problem is mycoplasma contamination? The answer is very big. A variety of studies conducted worldwide have found that mycoplasma contamination in laboratory cultures varies from 15-80% (1). Mycoplasma contamination is a very real concern for research labs, largely due to the fact that contamination can impact cells’ behavior and thus compromise the validity of experimental results and study data. In fact, this widely recognized problem has led many research publications to require authors prove that the cells used in their studies are free of mycoplasma contamination…

Benefits of a defined, blood-free virus production media for vero cells

Vero cells are a very popular cell line choice for virus production in vaccine manufacturing. Reasons for their popularity include a long history of safety and successful proliferation in variety of vessel types including flasks, cell factories, and microcarriers in bioreactors. However vero cells are adherent cells and must be supported in attachment with a robust virus production media to ensure good growth and productivity…

In-house Rapid Mycoplasma Test Qualification Provides a Cost-effective, Quick Turnaround Solution for Cell Therapy Product Release Testing

Rapid microbial methods can detect microbial contamination faster than traditional testing methods. Rapid microbial methods also require lower sample volumes for testing because of increased assay sensitivity. The quicker turnaround time from sampling to results also supports final release testing closer to actual final product release, thus enhancing the product’s safety profile. The quick turnaround time and lower sample volume requirements also permit close to real time in-process testing, thereby enabling process analytics and quality by design initiatives. Quality by design is particularly important considering the high value of these therapies. QbD ensures that all critical quality attributes are met and having in-process information ensures better manufacturing control and decision making during manufacturing…

Risk Mitigation Plan for Biologics Manufacturing using a Quality by Design (QbD) approach

The FDA and the biopharmaceutical industry collaborated to move forward a Quality by Design (QbD) approach to biopharmacuetical manufacturing. QbD was created as a way to ensure that all critical quality attributes for a product are maintained throughout the manufacturing process. This week’s Two Minute Tuesday educational video provides an overview for creating as biosafety risk mitigation plan, an important part of the QbD process. Regulatory bodies have made it clear that testing alone is not a sufficient risk management strategy and this video walks through a risk management approach. For the full video, please see the video below titled, “Biosafety Risk Mitigation Plan Overview“…

Impurity Precipitation Strategies for Intensification of mAb Downstream Processes

Impurity precipitation is focused on process- and product-related impurities which have to be removed during the downstream process in the manufacturing of therapeutic proteins. Common impurities are host cell proteins, DNA as well as aggregates of the therapeutic protein. Moreover, the purification process must include steps which are able to inactivate or remove viruses to ensure the viral safety of the biopharmaceutical…

Implementing Process Analytical Technology (PAT) in Continuous Bioprocessing

Continuous bioprocessing presents many exciting opportunities for improving biomanufacturing. Frequently discussed are methods for incorporating Process Analytical Technology (PAT) initiatives into a continuous operation. One advantage of implementing PAT in continuous bioprocessing operations is the opportunity to not just analyze what has happened, but to make real-time process control adjustments for increased quality assurance and greater process efficiency…

Video – Viral Safety in Biologics Manufacturing

Regulatory bodies have long recognized that viral safety in biologics manufacturing is a top priority. The presence of adventitious agents such as bacteria, mycoplasma, adventitious viruses, endogenous retroviruses, fungi/molds and prions represent a significant threat with patient safety, medicine shortages, costly decontamination as the key concerns. While viral contamination is rare it has happened. To help prevent contamination regulatory guidelines have been established to evaluate viral safety in biologics manufacturing. These guidelines evaluate potential risk and establish testing requirements for the entire biomanufacturing process. This week’s Two Minute Tuesday educational video provides an introduction to viral safety and looks at areas of risk, the regulatory guidelines, testing requirements and critical steps in the biologics manufacturing process. For the full video, please see the video below titled, “Introduction to Viral Safety“…

Intensify process development steps and simplify transfer to GMP environment with new ÄKTA pilot 600 chromatography system

The bioprocess industry is leaving the blockbuster era. The strive to shorten time to market is constant, which puts pressure on the entire drug development process from research to manufacturing. With more drugs in pipeline, biomanufacturers need flexibility, efficient changeovers, and accelerated scale-up and transfer to the next development phase…

Cell Culture Heroes – Webinars on Cancer Research

Professional Training:

Continuous Downstream Processing Training Course

The BioFactory Competence Center (BCC) in Fribourg, Switzerland has partnered with Pall Biotech to offer a continuous downstream processing training course from 3rd – 5th July 2018.  Attendees will learn about the different technologies available for continuous processing steps including cell separation, filtration and chromatography.  The three day course is focussed on practical hands-on work in the laboratory with small class sizes.  Further information can be found at http://www.bcc.ch/continuous-downstream-processing.html.

Opened in 2016, the BCC is a non-profit educational facility dedicated to advancing the biopharmaceutical industry through educational sessions and real-time support. Pall Biotech is a leading manufacturer of continuous bioprocessing equipment.

Podcasts:

Check out our podcast channel. We have over 20 great podcasts covering drug discovery, stem cell culture, upstream and downstream biomanufacturing and more! Click below to download from iTunes or Google play:

Headlines:

“The Food and Drug Administration will soon be alerting companies that certain gene therapies in development can qualify for less arduous review at the agency, Commissioner Scott Gottlieb said Tuesday. Specifically, gene therapies for hemophilia, a rare disease in which blood doesn’t clot properly because it lacks certain proteins, could be evaluated based on whether therapy increases those proteins in the blood, regardless of whether the therapy actually causes the patient to bleed less…”

“Once there was a mutant worm in an experiment. It lived for 46 days. This was much longer than the oldest normal worm, which lived just 22. Researchers identified the mutated gene that had lengthened the worm’s life, which led to a breakthrough in the study of aging — it seemed to be controlled by metabolic processes. Later, as researchers studied these processes, all signs seemed to point to the nucleolus….”

“AstraZeneca has officially opened its new research facility in South San Francisco, bundling five of its Bay Area sites into a single unit at the heart of California’s biotech cluster. The new location—at the Cove at Oyster Point—is the new workplace for around 400 employees gathered from AZ’s TIDE (Technology Innovation & Delivery Excellence) unit, as well as subsidiaries Acerta Pharma, MedImmune, and Pearl Therapeutics…”

“House Passes ‘Right-To-Try’ Bill For Experimental Drugs,” National Public Radio

“Legislation that would allow terminally ill patients to get access to experimental drugs is headed to the president’s desk. The House on Tuesday passed a “right-to-try” bill that was approved by the Senate in 2017…”

“Drugmakers Call for More Clinical Trial Flexibility in Alzheimer’s Drug Guidance,” FDA News

“The FDA’s guidance on developing Alzheimer’s drugs is overly rigid when it comes to enrollment of patients in clinical trials, drugmakers said in public comments. In its comments, AstraZeneca noted that the guidance calls for eligibility in efficacy trial enrollment to be based on “current consensus diagnostic criteria,” but said future guidance should acknowledge possible contradictions between such diagnostic classifications and the guidance. “As AD is recognized as a continuum, some flexibility is required, particularly for ongoing clinical trials,” the comment states. “Further dialogue is encouraged on the relationship between different classifications and the term ‘Early Alzheimer’s Disease’…”

“Experimental drugs poised for use in Ebola outbreak,” Nature

“Aid workers responding to the Ebola virus outbreak in the Democratic Republic of Congo (DRC) are seeking approval to treat patients with experimental drugs. These include three potential treatments — ZMapp, favipiravir and GS-5734 — that were given to patients during the 2014–16 Ebola outbreak in West Africa…”