Biopharma News

The CRO predicts investment communities will come to the rescue of small and medium companies looking to advance their candidates

The CMO has designed the new service to alleviate manufacturing challenges associated with positive controls and nucleic acid templates

The company's £0.5 million investment in mass spectrometry support accelerates biologics development and approval

European Commission pressures pharma firm over reduced shipments amid criticism for slow vaccine rollout across block

The CDMO gears up for rapid deployment of its clinical-to-commercial manufacturing operations for its seventh collaboration to help deliver COVID-19 treatments

The collaboration aims to accelerate the development and commercialization of groundbreaking cell-based regenerative cures

Expanded global capacity addresses growing demand for cell and gene therapy

AmpTec's differentiated PCR-based technology has shown to have advantages compared with other technologies for mRNA manufacturing

Manufacturing at Baxter's Halle/Westfalen, Germany facility will help increase commercial production and promote access in UK and European markets

The new facility will house up to 12 X 2000-L bioreactors and will be equipped to handle existing and new advances in manufacturing

The company hopes its newly built fill and finish facility will assume commercial manufacturing this year

The $40 million investment marks the company's third viral vector manufacturing site

The CDMO will use its gene and cell therapy commercial expertise to bring "remarkable innovation" to young eligible patients

Acquisition will extend the Chinese CDMO’s European footprint and will complement Leverkusen drug product site

CDMO will add two production suites for clinical and commercial supply and extend lab space to double analytical and process development capacity

The company will be responsible for the formulation, filling, and packaging of Ad26.COV2-S at its new €30 million injectable products plant in Barcelona

Two new facilities in Germany will provide clinical supply and cold chain services to support growing demand

Through the acquisition, Lilly will establish a gene therapy program via Prevail's gain clinical-stage and preclinical neuroscience assets

Dutch CDMO will expand with two additional viral vector production lines to meet the increased demand

The CDMO will provide packaging, labeling and distribution services through its FastChain demand-led supply offering

Twelve pharma market trends we anticipate across 2021 for the drug development, manufacturing and outsourcing sectors.

AZD1222 is 90% effective, cheap to produce and easy to store, distribute and administer

The partnership will focus on commercializing eight biosimilar medicines in China for the domestic market

Data also show that mRNA-1273 remains stable at 2–8°, the temperature of a standard home or medical refrigerator, for 30 days.

The facility will be the only cell-based influenza vaccine manufacturing facility in the Southern Hemisphere.

Europeans set to benefit from the EC's authorization of COVID-19 candidate vaccine supply agreement, securing up to 405 million doses of CVnCoV

The specialist CDMO's $150 million 3-year investment plan will provide a complete suite of virotherapy services to support drug developers and their most "revolutionary" products.

Smart, connected devices are revolutionizing drug delivery in the ways they can gather, order and transmit crucial patient data to physicians

CPHI lifts the lid on the relatively little known German biotech and partner of Pfizer behind the most promising COVID19 vaccine candidate

Gareth Macdonald

The coronavirus pandemic has impacted biopharmaceutical manufacturing and is likely to continue to do so for years to come. But the pandemic is not the only thing changing how the industry goes about making medicines.

This phase sees the CDMO start work on installing two 2,000-L single-use bioreactor trains in its mammalian cGMP facility.

Results from a Phase III clinical study found Pfizer and BioNTech's mRNA-based vaccine candidate, BNT162b2, is more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection, the companies announced Monday...

Altimmune adds Lonza as a manufacturing partner for supply of AdCOVID, its single-dose intranasal vaccine candidate for COVID-19.

For many years, well before the arrival of COVID-19, the pharmaceutical sector has faced increasing pressures, with challenges such as fake goods and grey market diversion. There is also increased emphasis on how to ensure patient adherence, as this di...

In this interview with Pharmapack, Arnaud Steiner, R&D Packaging Manager at Virbac shares his thoughts on trending issues in the packaging market such as patient centricity and eco-design, the challenges of managing the development of new packaging and...

Company is the latest in a lengthening list of pharma companies recalling the diabetes medicine over unacceptable levels of NDMA

The expansion will entail building two new facilities - one in Germany, the other in Japan.

The companies anticipate first results of Phase I/II in early December 2020, to support the initiation of a pivotal Phase III study before the end of the year.

The Russian Federation has become one of the first countries to apply to the WHO for prequalification of its vaccine, Sputnik V, against the novel coronavirus infection.

The ramping up of vaccine manufacturing demand amid the COVID-19 pandemic had an initial impact on cell and gene therapy production but the regenerative medicine sector has largely weathered the storm, according to senior industry figures in a recent p...

By Duncan Emerton, PhD; Director, Custom Intelligence, Informa Pharma Intelligence

The biopharma company collaborates with European and Canadian suppliers for large-scale ramp-up of opaganib manufacturing.

The recipe for efficiency by Universal Pack

MPA Technical Devices Srl is an Italian company specializing in designing and manufacturing top quality and accurate dosing systems.

CycloLab Cyclodextrin Research and Development Ltd. is a private SME with the focus on cyclodextrin research and development for over 30 years. We are working in the fields of pharmaceutical, cosmetic and food industry, agrochemical, environmental and ...

The increasing number of complex and sensitive biologics and the administration shift from hospitals to patients' homes are two of today’s main biopharmaceutical industry challenges. Complex drugs and self-administration require an appropriat...

Pushpa Vijayaraghavan  Director, Healthcare & Lifesciences Practice, Sathguru Management Consultants 

 

 

The rise of specialty and biologics has meant that one of the fastest growing segments by value today are Injectables demonstrating a 5-Year CAGR of 10%. This growth of course has implications and creates pressures across various areas such as treatmen...

Charbel Tengroth, Managing Director, Tengroth Consulting

With the Festival of Pharma now well and truly upon us, keep abreast of all that is happening and when over the ten days of this vast virtual event.

Festival of Pharma roundtable discusses how drug delivery formulation and development is focused on hospital-to-home care setting

The facility will enable the company to deliver Phase I to commercial manufacturing services for biologic projects.

The two suites, established with VMIC equipment and operated by Oxford Biomedica, will be operating at 1000-L scale.

Flexible support system simplifies and secures tubing paths for biopharmaceutical manufacturers.

BIA Separations will be Sartorius's center of excellence for purification of cell and gene therapeutics.

Scancell’s DNA vaccine could provide long-lasting immunity against COVID-19 by generating protection against this and new strains of coronavirus.

Hugh Purity New England's solution can utilize other vendors' components and can be implemented directly into any process.

Up to 500 doses of vaccine to be placed on a single wafer-thin and stored for extended periods of time.

Ingredients are the lifeblood of the pharmaceutical and nutraceutical industries. They connect today’s cutting-edge medicine and consumer products makers with their origins in the chemicals sector of the late nineteenth century. While ingredients...

The companies will commercialize six new biosimilar candidates addressing multiple therapeutic areas.

The targeted removal of one particular bacterial species from the skin microbiome, while preserving the beneficial ones, represents a new way to treat atopic dermatitis.

The second in a quarterly series of blog posts about responsible supply chain management from the PSCI Chair, Caroline O'Brien

Catalent to manufacture clinical batches of T-knife's platform process for TCR-based cell therapy at its site in Gosselies, Belgium, for European trials in 2021.

Novel, plasmid-free manufacturing system reduces the cost of goods and improves AAV quality to enable development of safer gene therapies.

Humanigen's proprietary monoclonal antibody may prevent and treat cytokine storm, which is believed to trigger the acute respiratory distress syndrome in severe cases of COVID-19.

The NevoLine Upstream platform has been designed to address the needs of gene therapy and vaccine innovators and CDMOs for robust and cost-effective upstream viral vectors manufacturing.

The global pandemic continues to impact lots of industries and slow down business, but the pharma and packaging industries are striving to tackle new challenges to bring more faster and safer solutions to deliver medication to patients. The Pharmapack ...

Pharmapack Europe, the leading conference & exhibition in pharma packaging & drug delivery business traded the successful 2020 edition at the beginning of February. The innovation gallery, as the key feature of this event, has gathered the most recent ...

There is a great focus on medical packaging as a means of protecting the drug, but there is still a long way to go when talking about the real needs of patients, and what packaging can do for them. For the past six years, Giana Carli Lorenzini,Postdoct...

The transaction will further complement and expand Mylan's complex injectables offering and presence in hospitals.

The partnership will focus on developing multiple ADCs using Catalent’s proprietary SMARTag site-specific bioconjugation technology.

Semglee available in vial and pen presentations at a 65% discounted list price, the lowest available for a long-acting insulin glargine on the market.

Bridgewest to develop the site into a full-service contract development and manufacturing organization.

In your quest to meet the regulatory requirements for your oral solids project, you may encounter significant hurdles. Anticipating these early on and thoroughly planning your approach can help. Experts in the Pfizer CentreOne global network, Gillian M...

Researchers have designed a simple, low-cost device for subcutaneous injection of viscous formulations.

Forbius's lead investigational asset, AVID200 holds promise as an effective and well-tolerated therapeutic in fibrotic diseases and immuno-oncology.

The company will prepare the Harmans facility to enable multiple production trains to run in parallel to produce the vaccine candidate drug substance commencing later this year.

The company will target working with small and medium biotechs who require a science-driven, rather than a volume-driven partner.

An exclusive interview with Mr. Sudarshan Jain, Secretary-General, Indian Pharmaceutical Alliance

Developments in smart packaging can add value to the pharmaceutical supply chain and help to tackle the threat of counterfeit products as the race towards producing a COVID-19 vaccine heats up Dr Alex Cole, Senior Strategic Marketing Manager, CPI

This milestone secures future production of CombiGene's CG01 drug candidate to treat drug-resistant focal epilepsy.

Company working to ensure broad global access to COVID-19 vaccine candidate, following approval from regulators.

The transaction will enable Sanofi to expand and accelerate development of BTK inhibitors across multiple indications, including MS and other central nervous system diseases.

Plant 4 will add 256 KL capacity to its site, which is scheduled to commence manufacturing activities in the second half of 2022.

The company is also scaling up its manufacturing capability with its partners — Lonza, Catalent and Rovi — should the vaccine get the green light.

New mid-scale microbial facility will support Servier with API for acute lymphoblastic leukemia therapies.

The company expects to manufacture the clinical-stage gene therapy product in its commercial-scale GMP manufacturing facilities.

Discussions relate to vaccine candidate using Sanofi’s recombinant protein-based technology combined with GSK’s pandemic adjuvant system.

The companies are set to manufacture globally up to 100 million doses by the end of 2020 and approximately 1.3 billion doses by the end of 2021.

Through this expansion, the CDMO will increase the total lyophilization capacity by 246% of the current capacity.

The $30 million investment will enable the site to handle large-molecule programs, with additional capacity for small molecule dosage form development.

The data generated through the partnership will help biopharma companies to develop robust manufacturing processes and minimize challenges during scale-up and commercialization.

Data on the first clinical use of lenzilumab in patients with severe COVID-19 pneumonia suggest promising results.

Sterile transfer solutions without compromising operational efficiency.

Junshi Biosciences cites Lonza’s GS Xceed gene expression system as a critical enabler for the program.

Further milestone paves the way for production of novel gene therapy drug candidate designed to treat drug-resistant focal epilepsy.

Companies agree that the key to tackling drug development complexity is collaboration.

Following on from the success of the inaugural iPitch launch in 2019, iNova Pharmaceuticals is delighted to announce the launch of a new round of iPitch challenges for 2020.

AJILITY is designed to speed novel or existing therapeutics from development to manufacturing and into the clinic.

The global outsourcing solutions provider is also set to expand its biotech capabilities in Europe.

The prefilled pen supports more convenient self-administration for patients with chronic type 2 inflammatory diseases.

Luxembourg, 28 May 2020 -- CordenPharma, a full-service Contract Development & Manufacturing Organization (CDMO) for the supply of APIs, Drug Products & Pharmaceutical Packaging, announces the signing of an amendment to their existing manufacturing agr...

The investment will add a multi-suite operation to the Canton facility, adding up to 1000L of viral vector capacity and is expected to go online by 2023

Novel platform initially focussed on high-resolution industrial-scale processing of therapeutic mRNA.

The French pharma company will also invest EUR 120 million to create a new research center at Marcy-l'Etoile dedicated to vaccines

Late-stage manufacturing services will be conducted at Catalent’s facility in Anagni, Italy in preparation for large-scale commercial supply of the vaccine

The deal represents the contract manufacturer's third US site.

Investment will double the site's drug substance manufacturing capacity and will expand its capabilities to include fill/finish, and enhance its current assembly, labeling and packaging services.

The collaboration will significantly increase the UK’s capacity to manufacture viral vectors vaccines as part of a national effort in response to COVID-19.

The collaboration with CGT Catapult will enable Achilles to increase its GMP manufacturing capacity to supply clinical trials of its novel T cell therapy products.

The CDMO produce drug substance at large scale for commercial manufacturing with the first 2 years valued at approximately $480 million.

Development partners believe orthopoxvirus vaccines have potential for scalability to supply very large markets 

The Boulder, Colorado, USA facility will increase global capacity and extend manufacturing scale.

The company will provide CDMO capabilities, capacities, and expertise to support the US government’s Warp Speed Program to pave the way for innovators to advance COVID-19 programs.

US TEC will support biopharma drug development throughout the lifecycle, helping them overcome the challenges of the container-closure system.

CDMO will operate new Swiss facility due for completion in 2021 to support production of next-gen haemophilia product

AbCellera, will use its antibody drug discovery platform to identify antibodies against up to nine targets.

Evolving biopharma quality demands, the shifting regulatory landscape and the COVID-19 pandemic mean CDMOs will need to get even better at finding talent if they are to strike recruitment gold