Biopharma News

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.

Partnership aims to increase the robustness and reduce costs for the manufacturing of AAV vectors.

Smaller bioreactors and high-density perfusion techniques needed as manufacturing makes significant efficiency improvements.

Facility to focus on developing and manufacturing the company's biosimilar portfolio.

Lonza expansion includes drug substance development, and drug substance and drug product manufacturing.

Provides single source of expertise for scaled production of complex biologics for gene therapy and vaccines.

Pall and Aetos to advance the market impact of biosimilars and deliver lower-priced, high-quality options to end users.

PureHale is a new portable drug delivery device designed for upper respiratory care.

The new services will focus on quality control analysis and stability testing of biopharmaceuticals.

The Sandoz US portfolios to be sold to Aurobindo include approximately 300 products, as well as additional development projects.

Customers to benefit from simplified, scalable solutions for intensified cell culture.

Company to use its combinatorial stem cell screening platform to develop technologies for the conversion of pluripotent stem cells into platelets.

US, Germany and Japan revealed as tier one nations in all categories with Sweden ranking the best of the rest.

SGS's expansion will enable the service provider to offer a full ICH Q6B physico-chemical characterization of biological products.

New service to reliably and reproducibly isolate exosomes from almost any biofluid.

Company moves away from manual processing in favour of automated, scalable platforms.

Agreement includes Pall's next-generation Kaneka KanCapA 3G sorbent for the primary capture of mAbs from clarified cell culture.

The plant will be first-of-its-kind in the US.

Pall and BioSciencesCorp unite to provide "total solutions" for today's drug manufacturers.

WuXi STA chosen for its end-to-end CMC platform for new drug development.

The ability to micro size drug-cell interactions will allow pharmaceutical and biotech companies to do 100x more testing for the same money spent as well as increasing productivity.

FDF launches at CPHI Korea as country set to become regional hub.

Consortium to develop advanced technologies for the manufacturing of ex vivo gene therapies.

Experts warn bio industry needs to do more to create a sustainable pipeline of talent.

Next expansion step will increase finished product capacity for recombinant proteins by more than tenfold.

Agreement will enable customers to achieve easier scalability of processes ranging from lab-scale to commercial-scale production of biopharmaceuticals.

With the capacity expansion, Thermo Fisher will have the second largest base of single-use bioproduction capacity at a CDMO in the world.

Sartorius Stedim Biotech introduces its mini microcarrier bioreactor for culturing adherent cells.

The contract manufacturer strengthens its pharmaceutical-protein business with Dutch acquisition

Revolutionary, innovative plant offers greater flexibility, speed and efficiency.

With the acquisition of Irvine Scientific, FujiFilm will have a full product line supporting customers supplying antibody drugs to assisted reproductive technologies and cell therapy.

Global analysis will rank each major biomanufacturing country’s market growth potential, innovation and competitiveness.

Extensive range of ready-to-use culture media available in bottles and plates.

Expansions to meet safety requirements for GMO S2 and BSL-2 biological products.

New manufacturing paradigm will save 25% of total costs and the need for proteinaceous A & G resins.

A new analytical tool, Electrical Asymmetrical Flow Field-Flow Fractionation (EAF4) is showing much promise in biopharmaceutical and nanoparticle applications.

Pall Biotech to focus on enabling drug manufacturers to rapidly transition from pre-clinical to commercial manufacturing.

Strengthens Sanofi's R&D strategy with innovative Nanobody technology platform.

Collaboration will leverage combined strengths of development, manufacturing and commercialization of biosimilars.

SSB will provide both facilities with end-to-end process solutions in single-use format.

Targeting the initiation of a pivotal patient clinical trial in the first half of 2018.

Libbs will commercialize the product in Brazil under the brand name Zedora.

Integration of supply chain a critical issue as industry globalises, with a resurgence in European manufacturing and biotech markets forecast.

Truxima is mAb biosimilar to Roche's MabThera (rituximab).

First clinical candidate, HPN424, is in development for the treatment of metastatic prostate cancer and expected to enter Phase I clinical trials in 2018.

Service complements existing services for this testing, to provide comprehensive analysis and characterization solutions for clients involved in the production and manufacturing of biopharmaceutical products.

Investment builds on company's expertise in small molecule analysis and the use of LC/MS-MS techniques.

The development will help meet growing global demand for albumin.

The design, planning and building work commences immediately and will deliver a purpose-built, dual-stream facility.

The Stax mAx, a single-use harvesting platform, minimizes the impact of process variability between batches.

Experts at ADC Bio warn of impending problems in the ADC pipeline with millions wasted in development costs.

Combined technology assets will provides pharmaceutical and biotech customers the unique opportunity to select a tailored expression system.

£4 million investment will allow the Biopharmaceutical Product Testing business to expand its finished product and raw materials testing and increase capacity to deal with higher volumes.

New event to create unique synergies between the parallel worlds of large, small molecules and contract services.

Investments will help the company to bring candidate biopharmaceuticals from bench to clinic.

The 30-million-euro investment will accommodate the growing needs of customers.

Use of PnuVax’s unique patented conjugation platform technology to produce the vaccine is expected to speed up biomanufacturing and increase yield for a greatly reduced per-dose cost.

The Chinese biopharmaceutical company acquires the Canadian biomanufacturing business of Therapure.

Pivotal studies with BAY94-9027 showed that bleed protection was achieved with extended dosing intervals.

Step towards strategic alignment of R&D resources to Healthcare priorities.

Biogen becomes the first company with approved biosimilars for the three most prescribed anti-TNF biologic treatments in Europe.

Cyltezo approved for the treatment of multiple chronic inflammatory diseases.

EP Vantage releases half-year reviews of pharma & biotech and medtech performance.

Results from the Phase III study included in the sBLA submission showed that treatment with Prolia for 12 months led to statistically significant greater gains in BMD at the lumbar spine and total hip compared to risedronate.

First study in the US to investigate an interchangeability designation for an adalimumab biosimilar candidate.

The mPath bioreactor control system is the first to be developed and delivered by a technology supplier specifically for their product line, allowing full access to bioreactor capabilities that current commercial solutions cannot provide.

Dermatology unit is rebranded Ortho Dermatologics.

The biosimilar's list price will represent a 35% discount to the current list price of Remicade.

NKTR-358 has the potential to treat a number of autoimmune and other chronic inflammatory conditions.

Company announces investments, the sale of several products and a proposal to close a UK manufacturing site.

Vote marks first proposed biosimilar trastuzumab to be recommended by the committee.

Blincyto is the first and only Bispecific T cell Engager (BiTE) immunotherapy to demonstrate superior overall survival versus standard of care chemotherapy.

Acquisition adds recombinant-based influenza vaccine to Sanofi Pasteur's portfolio.

First shipment of BIOCAD’s Acellbia to India is scheduled for September 2017.

First-and-only fully human monoclonal anti-epidermal growth factor receptor antibody approved by the FDA for this patient population.

If approved, Imraldi will be the third anti-TNF biosimilar in Biogen’s portfolio in Europe.

Xgeva is indicated for the prevention of skeletal-related events in patients with bone metastases from solid tumours and is the number one prescribed agent by oncologists for this indication in the US.

Sandoz now has four biosimilars approved in Europe - more than any other company.

The Committee will review analytical, pharmacokinetic and clinical data from studies involving ABP 215, including results from a Phase III study in patients with NSCLC.

QbD studies in upstream processing more rapidly performed.

Biosimilar infliximab alone could potentially save the NHS £89 million.

It is the first and only biopharmaceutical manufacturing site established by a multinational active pharmaceutical company in China.

New medium designed for hematopoietic cell culture for cell-based therapies.

Unique tool will allow massive quantities of cell culture data to be collected during upstream processing QbD studies.

Allows customers to achieve a more optimal output than they would using conventional batch or fed-batch processes.

This chemistry testing offer complements the company’s existing range of off-the-shelf biological assays for biosimilar products, providing a complete solution from one contract partner.

Site is also expected to house production of a new subcutaneous form of belimumab, which is currently under review with the FDA.

New generation of bioreactors combined with new Flexsafe STR bags offer a fully scalable, single-use system.

Transactions provide access to attractive pharmaceutical growth markets.

Company receives positive CHMP opinions for biosimilars rituximab and etanercept to treat immunological diseases. Biosimilar rituximab also recommended to treat blood cancers.

$130M USD investment to support growing market demand.

Greater filtration capacity with a smaller footprint than conventional filters, improving economics for biopharmaceutical manufacturing.

Applications include data from the largest international trial conducted in multiple myeloma.

System can achieve separations with higher resolution, reproducibility and recovery then has previously been possible.

For success in the biosimilars sector, manufacturers must adopt QbD, DoE and PAT initiatives.

Work on a second-generation fusion protein due to start in 2017 at Patheon's manufacturing facility in Brisbane.

Partnership formed to evaluate the impact of Amplycell’s novel cell fitness technology on expression capacity of Horizon’s bioproduction cell line.

Expansion plan comprises company's largest investment in the US.

Comprehensive development program show potential of GP2017 to treat inflammatory diseases, such as rheumatoid arthritis, inflammatory bowel disease and plaque psoriasis.

Represents Biocad's third authorized medicine for the treatment of relapsing-remitting multiple sclerosis.

Merck's €42 million investment expands the allergies business on a global scale.

MEDI8897 has been engineered to have a long half-life so that only one dose would be needed for the entire RSV season.

Reinforces position as a supplier of excipients and raw materials for the pharmaceutical and biopharmaceutical industries.

Second Biologics License Application accepted by the FDA for avelumab.

Partnership leverages Lonza's expertise in large-scale mammalian cell culture facilities alongside Sanofi's strength in developing and launching biologics based treatments.

More than 50% of patients in three clinical studies who used Siliq achieved total skin clearance within a year.