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Samsung Bioepis Opens the New State-of-the-Art Headquarters to Accommodate Next Stage of Growth and Innovation

Samsung Bioepis Co., Ltd. announced the opening of its new headquarters in Korea’s ‘Bio Cluster’ of Songdo, located in the Incheon Free Economic Zone (IFEZ), a specially-designated economic zone in the city of Incheon. The new site is approximately 52,000 square feet, and will be the hub of Samsung Bioepis’ drive for development of next-generation biologic medicines. Construction of the new building was completed in December 2020.

“We are very excited to be opening our new headquarters which will serve as the foundation for the company’s next stage of growth. Our colleagues who were previously stationed in two campuses in Korea will be working together at the new headquarters to accelerate our passion for health,” said Christopher Hansung Ko, President and Chief Executive Officer, Samsung Bioepis. “With the new office equipped with the state-of-the-art laboratories, we look forward to providing our high-quality biologic medicines with more agility and with stringent quality control so that patients around the world can have access to our proven medicines more quickly and more widely available.”

The newly established 12-story building will house approximately 1,000 employees, who will be working at the 17,300-square-foot laboratory space and 15,200-square-foot office space. Attached to the main building is a three-story ‘Welfare Center’ which includes 4,750-square-foot cafeteria, a gymnasium and a fitness center for employees to enjoy. Furthermore, the company has an onsite childcare center to support employees with young children.

Established in 2012, Samsung Bioepis has rapidly grown to have five biologic products in immunology and oncology with more than 215,000 patients treated with the company’s immunology products in Europe alone. The company is continuing its work to improve access to medicines through its unique ‘process innovation’ development platform and currently has five biologic candidates in its pipeline ranging from hematology and ophthalmology.

(Source: PR News Wire, 2021)


Solentim sets new standards in productivity with the launch of ICON™ and STUDIUS™; accelerating assurance rich workflows in the development of new biologics

Biond Biologics recently announced that the company has entered into an exclusive worldwide license agreement with Sanofi, for the development and commercialization of BND-22. 

BND-22 is a humanized IgG4, antagonist antibody targeting the Ig-like transcript 2 (ILT2) receptor in development for the treatment of solid tumors. ILT2, a member of the ILT family of immuno-modulating receptors, is an inhibitory receptor expressed on both innate and adaptive immune cells that binds MHC class I molecules including HLA-G, an immunosuppressive protein expressed by multiple tumor types. 

An Investigational New Drug (IND) application for BND-22 has already been submitted to the Food and Drug Administration (FDA) and a Phase 1 study to evaluate the safety, tolerability, and preliminary anti-tumor activity of BND-22 in advanced cancer patients is expected to commence in the middle of the year. 

Bournemouth, UK, 25th January 2021 / Sciad Newswire / Solentim, the trusted global leader in cell therapy workflows enabling the creation, isolation and characterization of high value cells, is delighted to launch two new solutions to enhance the development of therapeutic antibodies. ICON™ is a benchtop system for the rapid stratification of high productivity clones and STUDIUS™ is a proprietary software platform that delivers unparalleled data on each cell’s journey through cell line development.

The all-in-one ICON system assesses specific productivity using rapid on-board assays for the three critical quality attributes of titer, cell number and cell viability. Using plate-based imaging for static plate cell counting and cell suspension automated cell counting with viability for fed-batch, ICON generates normalized cell productivity data. This information enables cell line development scientists to separate the promising clones from the rest, saving resources and accelerating workflows.

STUDIUS is Solentim’s bespoke data management solution for cell line development. The over-arching platform is designed for Solentim’s instruments to provide control, management and reporting in the pursuit of lead candidates. STUDIUS delivers an unparalleled perspective on the journey of each individual cell, from seeding to selection, and intelligently manages verified information from multiple sources to enable scientists to select high value cells. Importantly, STUDIUS protects data, providing data auditing and integrity with a suite of tools applicable for laboratories working under 21 CFR Part 11 compliance. Using the novel HISTORYTREE™ visualization, STUDIUS maps each cell’s journey, presenting all the necessary cell data for regulatory approval in one report.

Dr Mark Truesdale, CEO, Solentim, said: “Our cell line development ecosystem of instruments – Cell Metric®, VIPS™ and now ICON – provides the optimal workflow solution for seeding, growing and selecting the highest value cells with quality evidence of assurance of clonality. Our protected ecosystem ensures data integrity, and our data-driven reporting prepares you for regulatory approval from day one.”

To find out how ICON and STUDIUS can take your cell line development workflow to the next level, or to arrange a product demo, please contact us.

(Source: Pharmiweb.com, 2021)


Eli Lilly says its monoclonal antibody prevented Covid-19 infections in clinical trial

Eli Lilly has announced that its monoclonal antibody prevented Covid-19 infections in nursing home residents and staff in a clinical trial, the first time such a treatment has been shown to prevent infection.

In November, the antibody, bamlanivimab, was authorized for emergency use by the Food and Drug Administration in treating patients with Covid who are at risk of more severe disease. An antibody cocktail made by the biotechnology firm Regeneron has also been authorized.

But Lilly believes its antibody could be an option not just to treat Covid-19 but to help prevent it in limited circumstances.

The study began in August and was conducted with the National Institute of Allergy and Infectious Diseases. Lilly used an unusual strategy: a fleet of refitted recreational vehicles that could prepare study drug, do lab work, and pull trailers that could be used as on-site infusion clinics. That meant that when a nursing home or long-term care facility had an outbreak, an RV could be dispatched. Lilly developed the antibody in collaboration with Abcellera, a Vancouver biotech.

Lilly enrolled 1,097 participants in the study. Of these, 132 tested positive for the SARS-CoV-2 virus, which causes Covid-19, at the beginning of the study. Of the remaining participants, 300 were residents of long-term care facilities and the rest were facility staff, including health care workers.

Among these, 965, symptomatic Covid-19 infections were reduced by 57%. Among the 299 patients who were nursing home residents, the results were stronger still, reducing symptomatic Covid-19 cases by 80%. In both cases the result was statistically significant.

There were four deaths among the 965 patients, all of them in the placebo group. When the 132 who tested positive at the study’s beginning were included, there were another four deaths — again, only among patients who received placebo. All deaths were in residents, not staff.

Among the 299 nursing home residents, there were four deaths attributed to Covid-19, all in the placebo arm. Among the 41 nursing home residents who tested positive at the study’s beginning, there were four deaths, again in the bamlanivimab arm.

In order to get a long duration of effect from the antibodies, Lilly used a dose of 4.2 grams, about six-fold higher than the dose authorized for use in patients with Covid-19. Bamlanivimab is given intravenously.

Eli Lilly will discuss with the FDA whether a new emergency authorization is warranted while Regeneron is conducting its own Covid prevention study in households where one member was infected.

Use of the monoclonal antibodies has been more sporadic than expected, in part because of distribution problems and in part because doctors and patients don’t know to ask for them. The government has purchased large stocks of antibodies from both Lilly and Regeneron; whether the drugs are used more after governments purchase them makes no difference to the companies.

(Source: Stat, 2021)


Almac Group Further Expands Global Biologics Testing Solutions

Craigavon, Northern Ireland – 26 January 2021 – Almac Sciences, a member of the Almac Group, has announced additional expansion of its biologics testing laboratory with significant investment in mass spectrometry equipment.

The new high-resolution mass spectrometer has been installed at Almac’s global headquarters, located in Northern Ireland, and will support its biologics offering for the analysis of peptides, proteins, glycoproteins and antibody products. This adds to the existing industry support at its new biologic testing laboratory based in Athlone, Ireland, announced just three months ago, which supports QC release and characterisation of biologics.

The £500,000 investment in a Thermo Orbitrap LC-MS instrument substantially increases the company’s capabilities in solving biologic analytical challenges and underlines Almac’s commitment to providing the latest in cutting-edge analytical solutions, equipment and facilities for its global client base. The instrument is capable of offering a complete analysis package to cGMP including amino acid sequencing, peptide mapping, disulfide bridge analysis using MS and MS/MS, glycosylation analysis, identification of post-translational modifications e.g. acetylation, phosphorylation in addition to biomarker discovery.

With this additional service, clients will benefit from an extended range of mass spectrometry services including the quantitation of genotoxic impurities, structure elucidation, isotopic purity determinations and high-resolution mass spectrometry of both large and small molecules.

John Robson, VP Analytical Services, Almac Sciences commented, “This new mass spectrometer reinforces Almac’s vision of delivering the best for our customers and substantially enhances the level and depth of services we provide.”

John Malone, Analytical Manager added, “We are delighted with this vital investment – whilst customer focus is always our priority, we are confident that the enhanced service offering will benefit our clients further.”

The addition of this equipment further complements the well-established range of analytical services already offered from Almac’s global analytical testing facilities located in the UK, Ireland and North America.

(Source: Pharmiweb.com, 2021)