This week’s headlines include: Government official: Coronavirus vaccine trial starts Monday, Univercells’ CDMO Exothera hopes to help scale COVID-19 vaccine manufacturing, China gives go-ahead for human trials of potential COVID-19 vaccine: state media, Regeneron plans early summer trials for new antibodies against coronavirus, Human Testing Begins Earlier Than Expected For U.S. Coronavirus Vaccine, and Germany tries to halt U.S. interest in firm working on coronavirus vaccine.
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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.
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 first participant in a clinical trial for a vaccine to protect against the new coronavirus will receive an experimental dose on Monday, according to a government official. The National Institutes of Health is funding the trial, which is taking place at the Kaiser Permanente Washington Health Research Institute in Seattle. The official who disclosed plans for the first participant spoke on condition of anonymity because the move has not been publicly announced…”
“With the novel coronavirus continuing its global spread, drugmakers are pouring massive resources into developing targeted therapies and vaccines. Now, a new CDMO from Belgium’s Univercells is hoping its expertise can help drugmakers scale up their manufacturing for a successful shot. Univercells has launched Exothera, a viral vector CDMO targeting cell and gene therapy and vaccine developers, in a refurbished 161,000-square-foot facility in Jumet, Belgium, the company said Thursday…”
“China has given the go-ahead for researchers to begin human safety tests of an experimental coronavirus vaccine in the race to develop a shot against the COVID-19 epidemic that has killed more than 7,000 people worldwide. Researchers at China’s Academy of Military Medical Sciences, – affiliated to the Chinese People’s Liberation Army (PLA) -received approval to launch early-stage clinical trials of the potential vaccine starting this week, the ruling Communist Party’s People’s Daily reported on Tuesday…”
“Regeneron Pharmaceuticals Inc said on Tuesday it had identified hundreds of antibodies that could treat or prevent the coronavirus and was preparing to begin clinical trials by early summer, sending the drugmaker’s shares up 12%. The company will select the top two antibodies to develop a “cocktail” treatment and scale up its manufacturing to be able to produce 200,000 doses per month by the end of summer…”
“The first human testing of Moderna Inc.’s experimental vaccine against the novel coronavirus has begun, the National Institutes of Health said Monday. The National Institute of Allergy and Infectious Diseases, part of the NIH, said the study..”
“Berlin is trying to stop Washington from persuading a German company seeking a coronavirus vaccine to move its research to the United States, prompting German politicians to insist no country should have a monopoly on any future vaccine…”