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.
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Complex fluids such as liposomes are increasingly being used as a vehicle for drug delivery, but due to their nature, efficient and large-scale manufacturing can be challenging. One such challenge is sterile filtration, both from a throughput and bacterial retention standpoint.
Producing liposomes with precisely controlled particle size and distribution ensures an efficient downstream sterile filtration process. To overcome sterile filtration challenges appropriate decisions must be made during the selection, evaluation, and validation of filters intended for the sterilization of liposome-based drugs.
Participants will learn:
- The challenges of sterilizing liposome-based drugs prior to filling.
- A scalable method for producing liposomes with cGMP capability.
- Critical process parameters for sterilizing filtration of complex liposomal fluids.
- How to optimize sterile filtration of complex fluids and increase filter throughput using an example.
Thursday, March 19 8:00 PST; 11:00 EST; 15:00 GMT; 16:00 CET
Tuesday, March 24 8:00 GMT; 9:00 CET; 13:30 IST; 17:00 JST
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.
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.
- 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.
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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…
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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…
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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…
“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 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…”
“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…”
“If drug companies and insurers agree to participate, the Trump administration proposes limiting insulin costs to $35 a month for some older Americans…”