Biopharma News

Enzyme developed with CodeEvolver technology for preclinical therapeutics program exceeds agreement requirements.

Investment in advanced manufacturing of new respiratory and biopharmaceuticals portfolio.

The approval of SB5 could make Biogen the first company to commercialize three anti-TNF biosimilar therapies in Europe.

Enables explorations of new technologies and solutions to address development and manufacturing challenges.

The plant will manufacture biosimilars and construction is scheduled to start in early 2017, with full operations expected to commence in the third quarter of 2018.

In-depth profiling of IgG glycosylation coupled with ADCC assays enables generation of robust biosimilar comparability data.

Transaction to expand SSB’s bioprocessing product portfolio with innovative single-use centrifuges.

The partnership covers potential new medicines for atopic dermatitis and psoriasis.

State-of-the-art facility will foster the continued development of the biotechnology industry in China, further supporting national healthcare reforms.

Investments of more than USD 1 billion in state of-the-art biomanufacturing facilities, backed by industry-leading capabilities as part of Novartis, positions Sandoz to deliver biosimilars at unprecedented scale.

New expandable benchtop workstation with unique single-use bioreactor design offers a simple approach to process development for fermentation and cell culture.

Cellca’s cell line and upstream process development services now integrated.

The addition of Crohn's disease, fistulising Crohn's disease and ulcerative colitis to the approved indications was granted on the basis of similarity between Inflectra and the reference product, Remicade.

Offers a fast and cost-effective solution for manufacturers to reduce the risk of virus contamination resulting from raw materials during fermentation.

Total fund size doubled to up to €300 million.

The new facility will significantly increase Alvotech’s production capacity enabling the group to produce higher yields at lower costs.

Company will be one of the first service providers to offer HDX-MS in a cGMP environment.

Enables Fujifilm Diosynth’s customers to benefit from MSD’s strong track record with large-scale microbial operations.

Addition of a Bioreactor 3PACK production facility to its Copenhagen facility provides additional flexible solutions for clients.

Certified leading upstream platform powers China’s biopharmaceutical development.

Biogen to manufacture and commercialize Flixabi, the company’s second anti-TNF biosimilar therapy in the EU.

The contract is to conduct in vivo studies of generic drug products in human subjects from 2016 through to 2021.

$280 million project increases workforce, adds new capabilities

Benralizumab first AstraZeneca respiratory biologic to complete Phase III.

Construction now complete on new 62,000 square foot facility.

GE Healthcare delivers world’s first modular manufacturing solution based on single-use bioprocessing technology in just 18 months.

Lilly has received additional designations for olaratumab from the FDA, including Breakthrough Therapy, Fast Track and Orphan Drug, for this indication.

200,000 sq ft state-of-the-art biopharmaceutical manufacturing facility supports expanding development pipeline and transition toward commercial stage.

New Lynx CDR connectors facilitate faster and more economic biopharma fluid management.

The commercial launch of the CAS is the first in a series of product launches that enable continuous bioprocessing.

Also offers a powerful state-of-the-art refrigeration system with advanced temperature management.

This new service offers a number of advantages compared with current analytical techniques.

How providing comprehensive data can accelerate drug development.

Neuraminidase, which is not currently the main target antigen in traditional flu vaccines, enables newly formed flu viruses to exit the host cell and cause further viral replication in the body.

Novel enzymatic, 1-step site-specific protein conjugation technology for ADC production.

Ascenion unveils technology highlights: New approaches for the treatment of neurodegenerative disorders and glioblastoma.

Exciting lectures and discussions on therapeutic fusion proteins.

New company to develop novel cell-based cancer immunotherapies in China.

The combined offering is aimed at helping biopharmaceutical manufacturers increase productivity, improve efficiency and reduce costs.

New biologic for add-on maintenance treatment in adults with severe asthma and an eosinophilic phenotype.

New ready-to-use assays enable quick and simple generation of precise biosimilar comparability data.

Thermo Scientific Sorvall BIOS 16 centrifuge designed to provide simplified, flexible bioprocessing.

Scientists can meet with BioPharmaSpec experts at BioPharma Asia to discuss characterization strategies for accelerating their biosimilar development.

ModiQuest will screen their high class in-house phage display libraries, ModiPhage.

GBI Research says pipeline consists of 29% monoclonal antibodies.

The packaging has been specifically designed for the processing of small batches such as clinical and technical lots, orphan drugs or personalized medicines.

Proprietary Veltis technology used in FDA approved Idelvion.

The draft guidance explains that FDA will not approve any pending or tentatively approved application for a biological product under the FD&C Act after 23 March 2020.

Facility being operated by Avid Bioservices subsidiary with capacity to potentially generate additional $40 million in annual revenue.

Application based on data from KEYNOTE-010, which showed superior overall survival for patients taking Keytruda compared to chemotherapy in patients with PD-L1 expression on one percent or more of the cancer cells.

Certified quality of analytical services for developers of biologics and biosimilars .

£22 million investment in Liverpool by global biopharma company.

BalanCD CHO Feed 4 is a chemically-defined, animal component-free powder feed for large-scale bioproduction in a variety of high performing CHO cells.

Designed for use in biotechnological applications, especially for membrane screening and small-volume process development.

Symbiosis Pharmaceutical Services has picked-up several new clients in North America, which has primarily been driven by companies looking for small-scale aseptic manufacturing capabilities to support clinical trials.

First biotech company in Greater China region to receive European approval.

Deal strengthens Novartis immunology portfolio which includes investigational biosimilars adalimumab, etanercept and rituximab.

The first biosimilar monoclonal antibody reviewed, for all eligible indications.

Positive opinion based on reduction in the risk of disease progression or death with Empliciti in combination with standard of care regimen for multiple myeloma demonstrated in ELOQUENT-2 study.

Gary Zieziula to head biopharma business in North America and Marc Horn to lead biopharma business in China.

Redipor prepared media to be supplied directly to customers.

FDA grants Priority Review with target action date of 23 July 23 2016.

Transparency Market Research has announced the publication of a new report, titled "Biological Drugs Market - Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2014 - 2020".

New website will support clients in developing and implementing entire single-use bioprocesses.

Albumedix strengthens its leading position in albumin-based drug delivery through acquisition of Eleven's Supermin albumin technology.

The new stand-alone company Albumedix will continue to develop albumin-based products and technologies for the pharmaceutical industry.

The ideal solution for scaling studies and low volume ultra- and diafiltration operations.

Lonza adds two 1000-L single-use bioreactor systems to its current mammalian manufacturing capacity.

Sarilumab is an investigational, human monoclonal antibody intended for the treatment of patients with active, moderate-to-severe rheumatoid arthritis

The assets will broaden AmpliPhi's IP portfolio and speed the development of its phage therapies

Takeda intends to use the facility primarily for the manufacture of Entyvio (vedolizumab) and other biologic products.

The total investment is around a half billion euro.

Facility will manufacture biologics for clinical trials.

New offering incorporates clinical, commercial and regulatory insight to improve the probability of an asset’s commercial success.

The PnuBioVax vaccine contains heat shock proteins and multiple antigens produced by a modified form of S. pneumoniae, leading to a mechanism of action which is expected to be strain-independent.

Samsung Bioepis’ second immunology biosimilar approved, to be commercialized under partnership with Merck

The company showcases the innovative Syrina 2.25 auto-injector that brings the flexibility to design a unique form factor and also the full Syrina platform accommodating multiple primary containers and high viscous, high volume injections.

Supported by Phase III studies in moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis.

The projected FDA action date is 16 March 2016.

Coated stoppers for sensitive and high-value injectables.

First completed Phase III study of adalimumab biosimilar in the treatment of patients with moderate-to-severe RA.

The system offers parallel processing and walk-away control of 24 micro bioreactors.

Trastuzumab development and transfer for first Indonesian on-site production.

Raheen site will be largest capacity biopharmaceutical production facility in Ireland.

New S80 film features consistent cell growth, robustness and high quality.

Services include feasibility studies, process and analytical development and scale-up.

The plans include a multifunctional preclinical research facility and a state-of-the-art biologics manufacturing facility.

BioInject is a state-of-the-art facility that will be used to manufacture pre-filled syringes and devices for both Sandoz’s biosimilars and Novartis Pharma’s novel biologics.

The terms of the license cover commercial use of a genetically-engineered Chinese Hamster Ovary (CHO) cell line, developed by Horizon and adapted to manufacturing conditions by LakePharma.

The LakeCentre facility, located in Boulder, Colorado will increase manufacturing and production capacity to support the company’s extensive portfolio of biologics medicines.

The one-day conference, entitled “Safety and Efficacy — Clinical Trials Solutions”, will bring together experts from SGS Life Services and the wider pharmaceutical industry, to discuss advances in biopharmaceutical research and development and combine ...

Under the terms of the agreement, Aragen gains the rights to apply this technology to the development of recombinant cell lines with significantly enhanced commercial production levels compared to current methods.