Aspen Alert

Method and Device Assembly for Predicting a Parameter in a Bioprocess Based on Raman Spectroscopy and Method and Device Assembly for Controlling a Bioprocess A U.S. Patent for "Method and Device Assembly for Predicting a Parameter in a Bioprocess Based on Raman Spectroscopy and Method and Device Assembly for Controlling a Bioprocess" was awarded to Sartorius on June 25th, 2024. The present invention is a method of predicting a parameter of a medium to be observed in a bioprocess based on Raman spectroscopy including the steps of acquiring a first series of preparatory Raman spectra of an aqueous medium using a first measuring assembly; normalizing the first series of preparatory Raman spectra... https://lnkd.in/g8JR4hCZ #aspenalert #biotech #bioprocess

Overcoming the Inconsistent Cell Culture Performance Caused by Single-Use Bioreactors During Scaling-Up of the Manufacturing Process for a Therapeutic Bispecific Antibody Single use technology has been widely used in modern biopharmaceutical process development and manufacturing. However, there are concerns about the adverse effects of disposable materials on bioprocess, product quality and patient safety. Recently, we observed slow cell growth, increased lactate accumulation, and decreased production titer during scaling up a bispecific antibody (BsAb) upstream process from 3 L to 500 L bioreactor. To investigate the phenomenon, we conducted medium incubation and leachable spike-in experiments. We found that cell culture medium incubated in CX5–14 bag caused poor cell culture performance, which was correlated with the concentration of bis(2,4-di-tert-butylphenyl)-phosphate (bDtBPP), a breakdown product of the antioxidant Irgafos®168 in polyethylene film. Our results reveal the importance of evaluating leachable profiles from disposable materials during process development of bispecifics and other novel therapeutic modalities. https://lnkd.in/gU4G6viX #aspenalert #biotech #bioprocess

The Main Cause of Non-Relapse Mortality After CAR T Cell Therapy is Not What You Think CAR T cell therapy against CD19 and B cell maturation antigen (BCMA) is a potent immunotherapy for treating advanced B cell malignancies. It comes with a unique toxicity profile that includes cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), and hemophagocytic lymphohistiocytosis (HLH)-like syndromes. However, a new systematic review and meta-analysis led by investigators at Memorial Sloan Kettering Cancer Center (MSK) has revealed that none of these prototypical immune-related side effects are the leading cause of non-relapse mortality (NRM) – referring to all deaths not related to cancer progression or recurrence. Instead, they found infections are the main cause of NRM following CAR T cell therapy. https://lnkd.in/gBPiHRXT #aspenalert #biotech #bioprocess

Cannabis Medications Could Be Eligible for FDA Approval Under Proposed DEA Rules The US Drug Enforcement Administration has proposed new rules that mean, for the first time, medications containing delta-9 THC from the cannabis plant could be eligible for approval by the US FDA. The rules, if enacted, would move the cannabis plant from a schedule I to a schedule III substance, so its federal legal status would shift drastically from a narcotic with “no accepted medical use” to a regulated medication. https://lnkd.in/g7u2b2iU #aspenalert #biotech #bioprocess

Lotte Biologics Breaks Ground on $3.3 Billion Biologics Manufacturing Site LOTTE BIOLOGICS has broken ground on the first biopharmaceutical manufacturing plant at the Songdo Bio Campus in Incheon International City. The Songdo Bio Campus, a hub for the bio and wellness sector, represents an investment of $3.3 billion. Spanning more than 2.1 million sq. ft., the campus will feature three advanced production plants and auxiliary centers. The design, procurement and construction of the first plant will be managed by LOTTE Engineering & Construction. Each of the three plants will have a capacity of 120,000L– a total of 360,000L for the entire campus. Founded in 2022, LOTTE BIOLOGICS entered the CDMO sector by acquiring the biologics manufacturing site of Bristol Myers Squibb in Syracuse, New York. https://lnkd.in/gk76z82k #aspenalert #biotech #bioprocess

Samsung Biologics Nabs $1 Billion Manufacturing Contract with Undisclosed US BioPharma Samsung Biologics has entered into a $1.06 billion agreement with an unnamed U.S. biopharmaceutical company, according to a public disclosure the Korean manufacturer made this week. Details of the partnership were sparse as Samsung Bio only revealed that its partner was headquartered in the U.S. but did not name the company due to a non-disclosure agreement, according to Korea JoongAng Daily. https://lnkd.in/eWEHkgt7 #aspenalert #biotech #bioprocess

Takeda to Cut Another 220 Jobs in Massachusetts, While EMD Serono Plans Its Own Layoffs Just two months after telegraphing plans to lay off 641 staffers at two of its Massachusetts sites, Takeda is parting ways with another group of its workforce with more layoffs in the state. Elsewhere in Massachusetts, Merck KGaA’s biopharma subsidiary EMD Serono is set to do the same. The layoffs were disclosed in a recent Massachusetts Worker Adjustment and Retraining Act (WARN) report. Takeda’s job cuts will impact 189 employees at its Cambridge headquarters and 31 at its Lexington site from this August to March 2025. https://lnkd.in/gGve-Yfp #aspenalert #biotech #bioprocess

Thermo Fisher Scientific Launches Biobased Films for Biopharma Manufacturers Thermo Fisher Scientific has built upon its existing Aegis and CX film offerings to launch biobased films for its single-use technology bioprocessing containers (BPCs). The biobased films have earned an International Sustainability and Carbon Certification (ISCC) Plus certification. Biopharma manufacturers can prepurchase Thermo Fisher’s biobased films to incorporate into their upstream or downstream system in early 2025. In addition, Thermo Fisher says it will support customers as they track their carbon reduction quantities and advance towards their sustainability objectives. In addition to offering BPCs with biobased film, Thermo Fisher connects customers with recyclers to enable recycling of BPCs after use. This program turns BPCs into plastic lumber and helps biopharma manufacturers divert waste from landfill and incineration. https://lnkd.in/gVGekPdN #aspenalert #biotech #bioprocess

The New Frontier in CHO Cell Line Development: From Random to Targeted Transgene Integration Technologies Since CHO cells were first used as expression host for the industrial production of biologics in the late 1980s, stable genomic transgene integration has been achieved almost exclusively by random integration. Since then, random transgene integration had become the gold standard for generating stable CHO production cell lines due to a lack of viable alternatives. However, it was eventually demonstrated that this approach poses significant challenges on the cell line development process such as an increased risk of inducing cell line instability. In recent years, significant discoveries of new and highly potent (semi)-targeted transgene integration systems have paved the way for a technological revolution in the cell line development sector. This review summarizes recent advancements in the field of transgene integration technologies for CHO cell line development and compare them to the established random integration approach. https://lnkd.in/gyJ6MbDN #aspenalert #biotech #bioprocess

Sanofi Eyes German Insulin Investment of Up to $1.6 Billion, Source Says Sanofi is nearing a decision to invest between $1.4-$1.6 billion to upgrade its production of long-acting insulin shots in Germany, a person familiar with the plan told Reuters this week. The expected investment would be the latest in a string of recent wins by Germany's ruling coalition to attract foreign investments, particularly in the pharmaceuticals sector. German newspaper Handelsblatt, which first reported the investment plan, cited German government sources as saying Sanofi had changed course after initially considering shifting production of its insulin brand Lantus to France, and was now close to committing to an upgrade of its German site in Frankfurt's Hoechst district. https://lnkd.in/g8PT86Zq #aspenalert #biotech #bioprocess