This week’s headlines include: Prescription unfilled? These 30 drugs are in short supply in the US right now, Pfizer weighs working with BioNTech on potential coronavirus vaccine: R&D head, Is a ‘Universal’ Flu Vaccine on the Horizon? and Insulin Costs May Be Capped in a Medicare Program.

Podcasts:

Check out our podcast channel. We have over 40 great podcasts covering drug discovery, stem cell culture, upstream and downstream biomanufacturing and more! Click below to download from iTunes or Google play:

Webinar:

Preservation of Cellular Therapies 

May 18-19, 2020 – Minneapolis, MN

The course is offered for both in class attendance and over the web for those who cannot attend in person.

Intended audience

The course is designed for a wide range of participants.  The preservation of cells has applications in the fields of recombinant cell biotechnology, cell banking, cell therapy, regenerative medicine, and cell-based assays, for example.  Previous attendees have ranged from manufacturing engineers, laboratory managers, technicians, nurses, and scientists, and several companies have used the course as standard training for their employees.  The course material is designed for those who have little experience with preservation, as well as those proficient in preservation who is interested in improving their practices.

Lecture topics:

• Fundamentals of cryopreservation including mechanism of damage and strategies to prevent damaging cells during freezing, storage and warming,
• Step-by-step protocol development including methods by which to construct a new preservation protocol and debugging an old protocol that is no longer working well,
• Equipment, reagents and supplies used in preservation,
• The challenges in implementing preservation in a clinical/GMP environment,
• Fundamentals of quality control (QC) and quality assurance (QA) as well as application of the program to preservation,
• Design and operation of a storage facility for cryopreserved cells,
• Regulatory issues associated with preservation of a therapeutic product,
• Emerging technology and approaches for the preservation of cells.

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

Cool Tool – Real-Time Protein Titer Measurement Provides Fast, Simple Solution for Process Development and Production

Protein titer data is a critical during process development and manufacturing of protein-based biopharmaceuticals. Speed and accuracy of this data is key in instituting a process analytical technology (PAT) approach, as this allows for monitoring critical process parameters (CPP) and informs real-time decision making. In addition, this type of data when collected during process development enables optimization of cell culture conditions, protein yield, bioreactor run length and harvest time. Collecting this data during a bioreactor run is ideal, but can be time consuming and resource intensive with traditional tools…

Rapid Mycoplasma Testing for Biologics – Frequently Asked Questions

Cell and gene therapies are poised to revolutionize healthcare, however manufacturing of these products poses new challenges for quality and safety assurance strategies. This is especially true in testing for mycoplasmas, an ubiquitous and practically invisible bacterial contamination of cell cultures. These challenges were a common thread in presentations at the 2019 PharmaLab Pre-Conference Workshop on Mycoplasma qPCR Testing, especially given the anticipated revision of European Pharmacopoeia chapter 2.6.7. Consensus points included, the importance of using cellular matrices for testing and the potential of an implementation strategy that positions NAT as a fast first line of detection, followed by results verification via culture-based compendial methods…

Top 25 Cell Culture Dish Articles of 2019

Don’t miss our top articles of 2019! I have compiled a list of our most popular 25 articles for 2019 in alphabetical order…

Rapid Spent Media Analysis of Metabolites During Cell Line Development for Better Product Quality Outcomes

Spent media analysis is an important tool used to provide crucial information about the amino acids and nutrients that cells use during growth phase. Spent media analysis also provides details about the metabolites that are produced as a result of cell growth. This is useful to cell line and process development teams in that it provides data on media composition performance, optimal harvest time and product quality changes that can occur during culture…

CryoVault™ Freeze and Thaw Platform Provides a Scalable, Robust and Single-Use End-to-End Solution for Bulk Drug Substance

In this podcast, I talked with Max Blomberg, Executive Director of Operations and Andrew Govea, Senior Product Engineer, at Meissner about the challenges of handling bulk drug substance, specifically freeze and thaw and how the need for scalability, flexibility and a robust approach led to the development of CryoVault™. CryoVault™ offers a unique and intelligently designed end-to-end freeze and thaw process solution…

Innovative Single-Use Freeze and Thaw Platform for Bulk Drug Substance

Successful bulk drug substance freeze and thaw is a critical aspect of biologics manufacturing. It is also time consuming and labor intensive. Historically, cryovessels have been the most common technology used for freeze and thaw due to their durability and scalability. However, cryovessels require extensive cleaning processes and infrastructure and labor to maintain them. These challenges, led companies to look for single-use alternatives. While single-use significantly reduces cleaning requirements, they are difficult to scale due to limitations of the size of the bags. Another downside is that they can be prone to integrity issues…

Top Downstream Process Articles of 2019

Don’t miss our top articles on downstream processing for 2019! I have compiled a list of our most popular articles from 2019 in alphabetical order…

Automated Buffer Preparation – Increasing Production Capacity While Maintaining Footprint

Buffer preparation requires extensive footprint and is also resource-intensive. In fact, it is known to be one of the most resource-intensive activities in biomanufacturing as large volumes of buffers and process liquids are often required as production capacity increases. Thus the question exists how can buffer preparation be more efficient and not require footprint expansion. Is there a way to increase manufacturing capacity without increasing footprint and time spent on buffers? One possible solution is automating buffer preparation and I am pleased to share the following guest blog that discusses the advantages and addresses concerns about moving from manual to automated buffer preparation. I was fortunate to be able to interview the author about his article and have provided the transcript of our conversation following the guest blog…

Viral Filtration Validation Study Design – A Systematic Method for Choosing the Most Appropriate Test Approach

Viral filter validation is important to ensure the removal of viruses under the conditions seen at process scale when using scale-down models. When designing an effective study, there are key components that must be decided on. First, it is important to select a virus spike level that will allow for quantification of virus removal, without having a negative impact on the scaled down process. Second, it is important to understand how a virus prefilter will be incorporated into the study design…

Novel affinity resins enabling the purification of next generation antibody fragments: KANEKA KanCap™ G and KanCap™ L

Ever since the licensing of first monoclonal antibody (mAb) drug, biologics have seen unprecedented growth as drugs to treat a variety of malignancies¹. The modular structure of mAbs have allowed protein engineers to create smaller, nimbler, and multispecific next-generation antibody therapeutics. Some of these modalities can be easily produced using microbial expression systems, offering higher yields and excellent process economy²…

Headlines:

“Prescription unfilled? These 30 drugs are in short supply in the US right now,” USA Today

“The outbreak of the novel coronavirus has revealed the vulnerability of the supply chain of drugs that originate in China, which is the main supply source of raw ingredients for penicillin, ibuprofen, and aspirin. However, drugs are frequently announced to be in short supply. In fact, the FDA has a running list of drug shortages due to anything from increasing demand to regulatory factors as well as supply disruptions…”

“Pfizer weighs working with BioNTech on potential coronavirus vaccine: R&D head,” Reuters

“Pfizer Inc is considering a collaboration with German drugmaker BioNTech SE to develop vaccines for the coronavirus using BioNTech’s mRNA-based drug development platform, Pfizer’s R&D head told Reuters on Thursday…”

“Is a ‘Universal’ Flu Vaccine on the Horizon?” Health Day

“Work is proceeding apace on a “universal” flu vaccine capable of protecting humans from all forms of influenza, researchers report. A single dose of a synthetic universal flu vaccine called FLU-v appears capable of providing safe long-term protection across a broad spectrum of influenza viruses, a new clinical trial has shown. FLU-v outperformed a placebo in elevating people’s immune response, as measured by a number of different biomarkers related to the immune system, researchers found…”

“Insulin Costs May Be Capped in a Medicare Program,” New York Times

“If drug companies and insurers agree to participate, the Trump administration proposes limiting insulin costs to $35 a month for some older Americans…”