This week’s headlines include: Bayer, Exscientia to explore AI in drug discovery, FDA Finalizes Guidance on Annual Reports for Approved PMAs, California eyes selling its own brand of generic prescription drugs to battle high costs, FDA Seeks to Pull Nearly 250 ANDAs Over Unsubmitted Annual Reports, Verastem pens KRAS-focused drug licensing deal with Chugai, and After a Measles Scare, Seattle Cracks Down on Vaccine Compliance.

Podcasts:

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Conferences:

BPI West 2020

Don’t miss the chance to save 10% on registration for BPI West! Dish readers can register with VIP Code B20155DISH by January 17 and Save 10%*

The full agenda is now available for the upcoming BioProcess International US West meeting, held March 9-12, 2020 at the Santa Clara Convention Center in California.

Register your team to attend this year’s meeting to access 200+ case studies and new data presentations designed to improve the speed, cost and quality of your upstream and downstream processing efforts.

Trainings:

Continuous DSP

This 3-day training course will provide an introduction to continuous down-stream processing with hands-on practical and theory in process development and bio-manufacturing. It will give an introduction to different available technologies for continuous cell-separation, ultrafiltration, diafiltration and chromatography. The principles on process-integration, quality-by-design, scale-up and economic considerations for continuous processing will be discussed.

Location: Biofactory Competence Center in Fribourg, Switzerland

January 28-30, 2020

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

Cool Tool: In vivo-jetRNA^® as a promising tool for RNA therapeutics

Nucleic acid-based vaccination is a promising technology that is particularly attractive to prevent or treat infectious diseases and cancer. A nucleic acid vaccine consists of a genetic sequence that is administered in vivo to be taken up by cells that will express at their cell surface or secrete the encoded antigen for induction of an immune response. Main technical challenges associated with the use of nucleic acid vaccines are efficacy and safety. To address these challenges, it is important to take into account the following parameters during initial research development of a genetic vaccine: the type of nucleic acid used and the delivery method…

Automated, high-throughput solution for cell counting, concentration and viability

There have been many improvements in the area of cell counting and several instruments have been developed to move away from time-consuming manual cell counting. However, even with automated devices, the lack of throughput for cell concentration and viability measurements can create a process bottleneck, particularly at large-scale or industrial manufacturing. In addition, this lack of high-throughput can limit experimental design or create resource demand that isn’t feasible when large numbers of samples need to be analyzed…

Optimizing Characterization and Quantification of Therapeutic Oligonucleotides

Oligonucleotides (OGN) are a class of therapeutics comprised of short strings of synthetic nucleotides. OGNs have the ability to to alter, suppress or restore expression of target genes associated with disease or health. This makes them uniquely positioned to provide treatment for diseases with a known genetic component. There are currently more than 80 companies currently investigating OGNs to treat diseases and it is a therapeutic modality that is growing dramatically…

Intelligent Lentivirus Analysis – Coupling an Automated Imaging System with Artificial Intelligence

The number of gene and cell therapies in the clinic is increasing rapidly. With the increase in gene therapy manufacturing, comes the need for improved analytics during the production process. Analytics for Lentivirus production is particularly important as it is currently the second most common vector used in cell and gene therapy manufacturing…

New Technologies to Facilitate 3D Bioprinting of Transplantable Organs

Broadly, the term “3D printing” refers to processes where a computer model of an object is recreated using materials are deposited and fused (such as polymer liquid or powder granules solidified together), layer by layer, to create a three-dimensional object. It is not surprising that this simple premise sparked innovation in other fields such as biomedical research. In this iteration, known as 3D bio-printing, living cells are deposited layer by layer in combination with biological scaffolds to form a desired 3D organic structure. While the spirit is the same as conventional 3D printing, bio-printing is considerably more complex because the functionality of tissues and organs is not solely based on physical structure. There are key interactions with other cells as well as their microenvironment, which inform their tissue-specific role. Nevertheless, this technique can be leveraged to fabricate complex, functional, cellular structures for many applications, including basic research, personalized medicine (disease modeling), regenerative medicine (transplantation or prosthetics) therapeutic investigation (drug screening/development) and for use in bioassays (cosmetics testing)…

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…

Supplier Qualification and Material Selection – A Case Study of Biopharmaceutical Resin Manufacture

To ensure a safe and continuous supply of life-saving biopharmaceuticals, raw materials for biomanufacturing must be selected carefully and suppliers evaluated with much scrutiny. Several instances of drug shortages as the result of either a raw material shortage or contamination reinforce the need for thorough evaluation. Ensuring a reliable supply and the quality of the materials selected is of paramount importance…

Bioburden Control Strategies for Continuous Downstream Processing

Implementing continuous bioprocessing for biomanufacturing has been increasing in interest. As a result, questions have arisen about the implementation of this strategy for downstream processes. Of particular interest is maintaining a high degree of bioburden control in continuous downstream process. While bioburden control strategies for continuous processing focus on prevention, not unlike batch processing, many want to know if there are specific strategies that should be implemented with continuous bioprocessing that are different than those used in batch processing…

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…

Headlines:

“Bayer, Exscientia to explore AI in drug discovery,” PharmaTimes

“The companies have announced that they will use artificial intelligence (AI) to further the development of drug candidates for three of Bayer’s projects in the areas of cardiovascular disease (CVD) and oncology…”

“FDA Finalizes Guidance on Annual Reports for Approved PMAs,” Regulatory Focus

“The US Food and Drug Administration (FDA) last month altered and finalized a 2014 draft guidance explaining what information needs to be provided in annual reports for medical devices subject to premarket approval (PMA)…”

“California eyes selling its own brand of generic prescription drugs to battle high costs,” The Los Angeles Times

“California would become the first state to sell its own brand of generic prescription drugs in an effort to drive down rising healthcare costs under a proposal Gov. Gavin Newsom is expected to unveil in his new state budget Friday. A broad overview of the ambitious but still conceptual plan provided by Newsom’s office says the state could contract with one or more generic drugmakers to manufacture certain prescriptions under the state’s own label. Those drugs would be available to all Californians for purchase, presumably at a lower cost. The governor’s office said the proposal would increase competition in the generic drug market, which in turn would lower prices for everyone…”

“FDA Seeks to Pull Nearly 250 ANDAs Over Unsubmitted Annual Reports,” Regulatory Focus

“The US Food and Drug Administration (FDA) on Wednesday said it plans to withdraw the approval of 249 abbreviated new drug applications (ANDAs) after their manufacturers repeatedly failed to submit annual reports for the generic drugs. FDA says the manufacturers will have the opportunity to request a hearing to appeal the decision by filing a written request and providing the agency with a rationale for why the ANDA should not be withdrawn…”

“Verastem pens KRAS-focused drug licensing deal with Chugai,” FierceBiotech

“Verastem Oncology has signed a pact to license a drug targeting KRAS-mutation positive cancers from Chugai. Under the deal, which is worth only $3 million upfront, Verastem nabs worldwide development and sales rights to RAF/MEK inhibitor CH5126766 (CKI27) from Chugai, which is in tests for KRAS mutant solid tumors. The company will host an investor call to discuss the opportunity and a development update today…”

“After a Measles Scare, Seattle Cracks Down on Vaccine Compliance,” The New York Times

“After a measles outbreak sickened dozens of unvaccinated children in southwestern Washington State last year, school health administrators around the state went into crisis mode, intent on confronting the relatively low vaccination rates in the region. First, they got an assist from the State Legislature, which passed a law in May tightening exemption rules for the measles, mumps and rubella vaccine. Then school districts — including Seattle’s — sent letters asking thousands of families who did not have compliant vaccine records to get them in order…”