Biopharma News

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.

Partnership to explore and identify new tools and methods to modify and optimize the CHO cell line performance.

Keytruda also receives Breakthrough Therapy Designation for second-line treatment.

Rentschler will become the first and only CDMO to have access to Leukocare's patented SPS formulation technologies.

Developments in local manufacturing, regulatory strategies, market entry and harmonisation to be debated by MENA leaders and Government.

Amgen receives positive CHMP opinion for biosimilar adalimumab.

Provides the company with increased control over discovery research, antibody generation, medicinal chemistry and bioconjugation for generating antibody drug conjugates.

Comprehensive validation services for the Chinese market.

If approved, MYL-1401O has potential to be the first biosimilar trastuzumab in the US.

Expansionincludes the opening of two new process development centers in the US and China.

Published study results showed an overall response rate of 69.6% for MYL-1401O compared to 64% for branded trastuzumab.

Extension is the result of the submission of additional data regarding the commercial manufacturing process of the biologic.

Site will use the latest bioprocessing techniques and will employ flexible production strategies to enable it to supply both clinical- and commercial-scale products.

If approved, the product could provide blood cancer patients with access to potentially life-saving medicine.

New entrants, as well as smaller companies, will expand the use of cell culture-based manufacturing methods to increase their presence.

No clinically meaningful differences between biosimilar etanercept and the originator product in safety and efficacy over 52 weeks.

New services to enable US biopharmaceutical companies to accelerate development of biosimilars.

Biologics and monoclonal antibodies to become a bigger presence within the small-molecule-dominated landscape.

Potential to be first submission of a proposed biosimilar trastuzumab in the US.

If approved, avelumab, an investigational anti-PD-L1 IgG1, could be the first treatment indicated for patients with metastatic Merkel cell carcinoma.

Phase III study established equivalence in efficacy and similar safety profile between BI 695501 and Humira (adalimumab) in patients with active rheumatoid arthritis.

Inflectra will be the first biosimilar monoclonal antibody (mAb) to be available in the US.

Facilities chosen for their contributions to anti-infectives and vaccines.

Cadence Acoustic Separator system is a novel single-use solution for the clarification of cell culture bioprocess fluids.

Assemblies save up to 60% on processing time and offer a safe approach to ultrafiltration of biologics and vaccines.

Will enable manufacturers to reduce costs by eliminating cleaning and validation requirements, as well as hardware infrastructure.

New site expands the company's global operations for small molecule and biologics manufacturing, and marks the company's first manufacturing presence in Asia.

Amjevita is the first adalimumab biosimilar approved by the FDA and has been approved for the treatment of seven inflammatory diseases.

Company also in the process of setting up a training collaboration with National Institute for Bioprocessing Research and Training (NIBRT) to develop skills for Ireland’s biologics sector, training 1,500 professionals per year.

Innovative Twin system with two 3,000-L bioreactors and associated downstream processing equipment put into operation. Second significant expansion in one year.

Benralizumab Phase III trials met primary and key secondary endpoints.

Unique product and service portfolio extensively covers all steps from cell line development to commercial manufacturing processes.

The CDMO has expanded its capabilities with a new automatic vial filling line to meet increased demand.

Marketing Authorization Application to the EMA currently under review.

The partnership created a fucose knockout GPEx cell line expressing high levels of an anti-HER2 antibody.

Includes scale-up and GMP manufacturing of drugs in late-stage development.