Biopharma News

Second 140,000 square-foot facility is expected to open next year

The biologics market is Pharma’s fastest growing market. With such significant growth of a different breed of products, what are the opportunities and implications for pharma packaging and drug delivery manufacturers?

The detection of nitrosamine impurities in some finished dosages has opened up a whole new set of challenges for API manufacturers who need to perform risk evaluations of their processes

Japanese drugmaker plans to meet 100,000 treatment course target by July

Company becomes the fourth Indian pharma firm to secure FDA clearance in the last two weeks

The CultureOne separator system uses product-contact parts that are replaceable and made from recyclable material.

The head of the leading German pharmaceutical industry organization says German firms are working top-speed to find coronavirus medications.

The FectoVIR-AAV transfection reagent achieves large-scale transient transfection resulting in up to a 10-fold increase in AAV functional viral titer yields in suspension cell systems.

Symphogen becomes the antibody center of excellence within Servier.

US drug regulator, the Food and Drug Administration, has ordered the immediate withdrawal of all prescription and over-the-counter versions of heartburn drug, ranitidine – commonly known as Zantac – after concluding certain products may pre...

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As biopharma heads towards a new decade, extracting value from innovation remains a key theme in medicines development. However, rather than accepting the traditional model of novel treatments via the R&D pipeline as the innovative focus, the industry ...

China is stepping up its efforts to produce and ship active pharmaceutical ingredients (APIs), with a focus on meeting international demand, particularly for those showing potential to treat the COVID-19 disease, according to Chinese officials on Tuesd...

The Ritedose Corporation, a contract development and manufacturing organisation (CDMO) with a focus on inhalation and ophthalmic products, has partnered with ChargePoint Technology to ensure the sterility of its drug substance mixing process.

The patent covers the crosslinking of certain carrier molecules, for example, antibodies, via specific binding sites to amatoxins.

Together, the companies will provide APAC markets with a cost-effective alternative to the largest-selling blockbuster medicine worldwide.

The Contract Development and Manufacturing Organization (CDMO) and technology provider will use its CHO.RiGHT expression platform for high-titer cell line development.

The TheraPEAK SfAAV Medium is specifically designed to support the development of safe, scalable, gene therapies.

CDMOs build capacity to capitalise on biologics boom

Fujifilm Diosynth Biotechnologies will triple microbial production capacity at its UK Teesside facility after joint owner Fujifilm Corporation pledged to invest 9 billion yen (USD83 million) in the biologics focused CDMO.

Cell and gene focused CDMO Oxford Biomedica (OXB) has signed a licence and clinical supply agreement which could be worth up to USD227 million with Juno Therapeutics, the firms announced Wednesday.

The worldwide inter-dependency of pharmaceutical manufacturing is highlighted by the ongoing Coronavirus situation. How can the global supply of diagnostic kits, drugs, medical supplies, and equipment be sustained to treat patients in the face of suppl...

Company awarded US$5 million grant for clinical study of measles and rubella vaccination using Vaxxas’ high-density, micro-array patch.

Is the pharma industry making the most of AI’s potential when it comes to accelerating and enhancing pharmaceutical drug development?

Following the 2018 FDA approval of GW Pharmaceuticals’ Epidiolex®, there has been increased interest in the development of cannabinoid-derived drug substances for innovative new therapies. We examine the state of the market and future potenti...

Company launches BIOSTAT STR Generation 3 bioreactor with BIOBRAIN automation platform.

The US Food and Drug Administration (FDA) accepts for review Pfizer and Eli Lilly's Biologics License Application (BLA) for tanezumab — a non-opioid treatment for patients with chronic pain due to moderate-to-severe osteoarthritis.

The White House task force and the US President will meet drug makers this afternoon to discuss "progress on a vaccine and cure".

With the world’s attitude to tackling climate change arguably the global number one hot topic of 2019, the issue of sustainability is an emerging theme in pharmaceutical packaging.

Agreement gives BIA Separations access to proprietary technology to better preserve integrity, infectivity and potency of immunoaffinity-purified viral vectors for gene therapy.

Unlocking the potential of Raman spectroscopy as a high throughput analytical technique for monitoring cell culture in mini bioreactors.

Identifying areas of unmet need to guide R&D strategy and shape drug pipelines

The investment will support continued expansion into the fast-growing gene therapy segment, including new developments that will enable a range of best-in-class solutions for viral manufacturing.

Investment in resources to meet demand for large-scale supply of patented biocompatible surfactant.

The company aims to simplify its customers’ work and thus help them to achieve medical progress and make innovative medicines available faster.

With CPHI North America fast approaching, we asked several industry experts what they see as the main trends emerging across the US pharma supply chain this year.

Agreement will facilitate clinical trial translations in China.

If proven safe and effective, mAb CIS43LS might be used prophylactically by tourists, medical workers or military personnel who travel to areas where malaria is common.

€250 million to be invested during the 2019-2022 period in new facility bridging research and manufacturing.

The company targets ERAP antigen presentation pathways with the aim of ‘illuminating’ non-responsive tumours for attack and destruction by the immune system.

First drug product facility in Europe to complement WuXi Biologics’ existing commercial manufacturing capacities.

BMN 307 represents a potential third PKU treatment option from BioMarin and its second gene therapy clinical program.

Biopharma’s desire for fast, cheap production and cell and gene therapy firms’ need for consistency is shaping tech development in the sector.

The product being developed will use proprietary drug formulation technology platform Arestat to deliver new reformulations of existing, complex products.

Capacity to serve global late-stage development and commercial manufacturing of monoclonal antibody drug substance to support new product launches.

Customers and partners look set to benefit from reduced development times and costs of medical drugs.

We asked ten industry experts for their thoughts on some of the emerging trends for the pharmaceutical supply chain as the industry enters 2020...

CMO's customer base has grown by more than 25% in 2019 alone, and investment and demand for services is estimated to increase output by another 25-30% in 2020.

Lead asset THOR-707 being explored across multiple solid tumor types alone and in combination with immune checkpoint inhibitors and other future IO combinations.

Lilly Gateway Labs will provide biotech companies direct access to Lilly scientists and expertise.

ClearMixx performs liquid/liquid and powder/liquid mixing, with a dispersion plate able to efficiently mix the most challenging buffer, media and biopharmaceutical ingredients.

The rise in exports growth potential is believed to be in response to concerted reforms by the CDSCO and industry quality improvements in the last few years.

China-US trade challenges has led to de-risking by pharma companies.

Companies and individuals from across the whole pharma supply chain recognised for their excellence and commitment.

But personalized medicines will require new logistics and manufacturing systems.

Demand for biological manufacturing is growing faster than capacity growth.

Company to reach 250 employees by year end to meet growing drug product manufacturing demand.

A shortage of qualified personnel may be a drag factor in cell and gene therapies; in China 100,00L of capacity will need to be added every year to meet bio demand.

15,000 sq. ft of laboratory and office space will enable continued growth and development of the company’s integrated desktop platform for DNA synthesis.

Outsourcing, biologics, generics and patient compliance look set to get tongues wagging at this year's CPHI WW.

Highest level of data integrity as requested by regulatory authorities.

One of the first digital manufacturing facilities in the world to use continuous, intensified biologics production technology.

Roquette works closely with customers in the development of innovative pharmaceutical formulations and new biopharma solutions.

Coordinated purification process development service accelerates progress to clinical trials, and scale-up manufacturing.

IKS01 shows marked anti-tumour efficacy in pre-clinical models of ovarian and lung cancer.

Platform will enable scientists and biotechnology entrepreneurs worldwide to make discoveries faster and more efficiently,

Part of nearly $400 million in US manufacturing investments to deliver on the company’s pipeline and bring medicines to patients faster.

Delivers enhanced galactosylation for improved protein quality, and antibody binding and function.

Worldwide agreement with Polpharma gives Sandoz commercialization rights to proposed biosimilar natalizumab for relapsing-remitting multiple sclerosis.

Company's antibody screening platform minimizes the risk of missing a blockbuster.

The five-level production facility contains a state-of-the-art manufacturing line for viral vaccines and viral vectors and a separate protein manufacturing area with a capacity up to 1,000-L single-use bioreactors.

Bringing freeze drying and vial washing/sterilizing technologies together with advanced and comprehensive vial and syringe filling capabilities.

Integrated package of new and established services saves time and minimizes risks.

Meet REVOLUTION BEYOND INNOVATION at Cphi Worldwide 2019, Booth No. 42C06

The GMP facility has been specifically designed to deliver the next generation of anticancer blockbuster ADC drugs for patients globally.

It is hoped that research into PROTACs will lead to new drug discoveries for proteins present in cancer, which are difficult to treat with conventional small molecule inhibitors.

The space will support cGMP manufacturing of animal component-free, dry powder media, liquid media, and downstream bioprocessing liquids.

Demonstrates the unique ability of diffusional sizing to assess protein binding in-solution and for difficult-to-study systems.

Cyclolab Ltd. is an R&D and cGMP manufacturing company focusing on all aspects of cyclodextrin science, manufacturing and applications for cyclodextrin, Dexolve, Sugammadex, formulation development, custom synthesis, Niemann Pick C.

Designed for gentle stirring and optimum growth of cell lines.

New Thermo Scientific Cytomat 2 C-LiN Series Automated Incubator delivers robust and reliable culture solution for cell-based pharmaceutical applications.

Transaction will create a leading biopharmaceutical company with approximately $48 billion in combined 2019 revenue.

Ready-to-use immunoassay kit increases analytical output and productivity in bioprocess workflows.

Industry leaders give voice to issues and trends shaping the biotech sector, including the importance of collaboration.

Univercells' propriety bioproduction platform has already proven success.

Funding will also be used to further expand operations in the UK and US.

Regulatory reforms and harmonisation reported as key drivers of industry in China.

Acquisition of Paragon Bioservices brings specialized expertise in adeno-associated virus and will enhance Catalent’s biologics business and end-to-end integrated biopharmaceutical solutions for customers.

Company has also invested in an Äkta-ready chromatography system for downstream processing and liquid handling equipment to deal with increased volumes.

SSB's new generation of ambr 15 supports cell and gene therapy applications, including HEK293 for viral vector production, T-cells, iPSCs and other immune-derived cell lines.

India predicted to be one of the world’s ‘fastest growing bio’ hubs in 2019, fuelled by new biosimilars production.

Offers an alternative to cross-adsorbed secondary antibodies when absolute specificity is required.

New guidelines will see poorer quality manufacturers drop out of the market.

Lonza and Chr. Hansen create a strategic joint venture to become the partner of choice for developing and manufacturing live biotherapeutic products for pharma and biotech customers.

Company's hybrid solution claims superior performance compared with tradition single-use technologies.

Scientists to rapidly obtain detailed process understanding and control over their microbial cultures.

Pall and Broadley-James’ combined expertise proves complementary in addressing critical customer pain points in modern bioprocessing.

Optimally run membrane chromatography processes will provide higher productivity, smaller-scale operations and increased robustness.

Nightstar Therapeutics has two potentially first-in-class mid- to late-stage clinical assets as well as preclinical programs.

Executives predict Japan to be the second fastest growing mature market for solid dose drugs in 2019, and the second fastest overall country for biologicals growth.

MedPharm and Palvella Therapeutics hope to develop the first approved treatment for PC in the US and Europe.

Researchers to benefit from an innovative software-connected pipetting system, bringing improved reproducibility and traceability of experiments to life-science laboratories.

Acquisition will strengthen Hitachi's presence in the second-largest cell and gene therapy market in the world.

Company hopes to contribute substantially to further optimizing and accelerating the current manufacturing processes in the biopharmaceutical industry.

The partnership will focus on rings for the administration of existing approved drugs, improving drug effectiveness and patient compliance.

Clients will benefit from a fully comprehensive range of validated biosafety methods to support cell bank and viral vaccine manufacturing and lot release of drug product.

The first completed bio-banks will be used to develop more cost-effective, safe and efficacious cancer treatments.

Fuels growth and biosimilar development in a fast-growing market.

Flexsafe RM TX bags enable reliable process performance for optimal cell growth.

The automated NevoLine bioproduction system that facilitates safer, faster and closed bioprocessing in a much smaller footprint.

The new, strategic presence will allow the company to more easily interact and engage with venture firms and start ups in the area.

The technology will enable Cell Guidance Systems to manufacture TRIFic detection assays on-demand with highly reproducible and scalable results.

Significantly expands Phase III assets with six expected near-term product launches, representing greater than $15 billion in revenue potential.

The CoE showcases the latest end-to-end technological solutions for biomanufacturing.

Enhances company's capacity to develop and deliver lentiviral vector and gene-corrected hematopoetic stem cells for wide range of diseases on a global scale.

Cobra Biologics, Pall, and the Cell and Gene Therapy Catapult share £1.5 million grant from the UK's innovation agency.

Extra funding for strategic move into downstream formulation and fill finish capabilities and full exploitation of Lock-Release as new ADC manufacturing paradigm.

Sartorius Stedim Biotech will continue to offer Lonza media and buffer products but under a non-exclusive agreement.

BioProduction’s content platform will be added to the bioLIVE exhibition, creating one of the world’s largest event hubs for the bio industry.

Company will focus on robust biosimilar portfolio for unmet access and sustainability needs.