Biopharma News

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 ...

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.

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.

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

$60 million Worcester plant should be operational by 2022 and will employ 150 people

Pharma start-up will use continuous manufacturing to shore up supply chain of essential medicines

At this year’s Pharmapack Europe, we interviewed Gregor Anderson, Managing Director at Pharmacentric Solutions on how the industry is striving for greater sustainability with regards to packaging and devices.

Listen to recordings of all webinars broadcast during the week of May 04-08

The ongoing pandemic has fuelled debate about whether Western pharmaceutical supply chains and API sourcing are too dependent on lower-cost Asian suppliers such as China. Do the US and Europe need to bring manufacturing back home?

EUR 25 million first stage expected to be completed by mid-2021 as COVID-19 pandemic highlights need for more European capacity

Biotech in discussions with pharmaceutical and chemical manufacturers on how to broaden supply of antiviral that last week received an emergency use authorization for treatment of COVID-19 from the FDA

Using this critical antibody reagent at the preclinical stage of development will minimize the need to revalidate assays with different reagents at the clinical development stage.

The new business unit will focus on existing automated biomanufacturing products, as well as launching new technologies.

The addition of various laboratory and bioprocessing technologies will support customers to develop biotech medicines and vaccines.

Collaboration leverages CDMO’s expertise in tech transfer and manufacturing to aim for 1 million doses per day

As biopharma searches for vaccines and treatments to alleviate the crisis, how can companies manage shortened timelines to rapidly develop and manufacture safe and effective products on a global scale? A recent Endpoints webinar sheds some light

Antiviral drug has been developed in-house with API manufacturer signed up to secure KSM

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