Biopharma News

CDMO currently manufacturing LAAB combination treatment  and will start on cancer immunotherapy product from next year

The new agreement extends to 2028 and allows Oxord Biomedica to work with other potential partners across all CAR-T targets

A 30,000-sq. ft cGMP facility and a separate R&D site will work alongside each other to provide end-to end product development solutions for Singapore and low- and middle-income countries

It could take pharmaceutical companies months to tweak their COVID-19 vaccines to provide sufficient protection against the Omicron variant of the coronavirus if it poses a risk of serious illness.

The offering will accelerate timelines for the development and manufacturing of molecules and disruptive technologies

In this special edition podcast, Informa Markets pharma editor Gareth Carpenter speaks to Bikash Chatterjee, CEO at Pharmatech Associates and Dan Stanton, Editor and Founder at BioProcess International about some of the findings in the recently pu...

The facility's total 60,000-L capacity supports growing demand for manufacture of late-phase and commercial projects

The expansion includes the installation of a pilot suite with a 50-L fermenter and automation upgrades to accelerate clinical and commercial projects

SK's financial backing enables CBM to address significant capacity constraints in the cell and gene therapy manufacturing space

The proposed state-of-the-art facility could potentially produce up to 100 million vaccine doses each year for Australians

The first-of-its-kind centre will offer biopharma clients convenience and efficiencies in the rapidly expanding Northeast

The increasing outsourcing trend among pharmaceutical companies represents a promising opportunity for CDMOs. This panel discussion at CPHI Worldwide touched upon some of the opportunities, hurdles, and trends ahead for the CDMO market

Expected increase in approvals for gene therapies, gene-modified cell therapies and recombinant vector vaccines will also increase pressure on manufacturers to build new capacity

Upcoming Late Stage Bioprocessing & Viral Vectors Digital Week running 2-11 November will address many goals and challenges associated with optimizing biologics manufacturing through different stages of the process

Clients to receive accelerated quality testing and reduced turnaround times

By completion at the end of 2022, the campus will accommodate 18 cGMP viral vector manufacturing suites

One site will focus on microbial production, the other on small-scale mammalian-based production

Together the companies will attempt to overcome "black box" challenges to enable more robust and consistent results for clients

The biologics CDMO says it expects its new 53,000-sq.ft facility will be operational within 18 months

The transaction expands the CDMO's GMP biopharmaceutical and vaccine manufacturing capabilities

The new the 140,000-sq. ft facility will support commercialisation and industrialisation of viral vectors

The LSCC provides an additional 30% in mammalian large-scale capacity for the company's own pipeline and for third parties

Quantum computing technology uses quantum systems called “qubits”. They work with non-binary values, unlike classical computing which uses only bits with values of 0 or 1, and can overlap each other and act as a group. The result is a ...

By providing AAV process development, scale up and cGMP manufacturing services, Forge hopes to bolster Solid's gene therapy pipeline

The facility will increase the production capacity of cell culture media products and provide a hub for European and global markets

The company's new Gibco AAV-MAX Helper Free AAV Production System helps reduce production costs and streamline transition from research to clinical environments

The expansion is anticipated to speed up development and time-to-market of novel treatments and vaccines for COVID‑19

The expansion plans include an additional manufacturing line, a new cleanroom and a new process development lab

Investment will further expand CDMO's global network of SUT facilities to boost reliable supply of critical materials used to produce new biologics and vaccines

The CDMO will manufacture drug substance and drug product for Phase II clinical trials in AML patients

Japan's biggest drugmaker prepares to make the vaccine domestically and anticipates early 2022 distribution

The new Switzerland-based CDMO differentiates itself by its sustainable vision of making a positive impact for people and planet

Companies say earlier collaboration may speed development and introduction of targeted precision medicine therapies for patients.

The agreement is expected to accelerate Cipla’s global lung leadership agenda

£35 million public-private collaboration to develop next-generation pharmaceutical manufacturing processes to drive forward innovation in the medicines supply chain

The new facility will augment the company's capacity to broaden its portfolio of perinatal-derived products

Pfizer and BioNTech’s shot on Monday became the first COVID-19 vaccine to be granted full approval by the US Food and Drug Administration.

mRNA (Messenger ribonucleuc acid) technology has been thrust into the limelight in recent months, with the platform proving to be the springboard for two approved vaccines against the SARS-CoV-2 virus.

New site in Cardiff boosts the company's production capacity for equipment crucial in the supply chain for mRNA vaccines production

The new facility will provide access to domestically manufactured vaccines against respiratory viruses

Innovation is the cornerstone of the drug delivery technology sector; efforts to make therapies more convenient for patients, reduce side effects and differentiate products from the competition have always made the delivery sector a hotbed of new ideas...

Tech transfer is a crucial phase that converts clinical promise into commercial gain but pressure on sponsors to reduce time to market in the age of COVID-19 means CDMOs have to be on top of their game to deliver. What are the latest innovations to sol...

Explore the series of Learning Labs at CPHI North America in which thought leaders at our exhibitors showcase their extensive knowledge on all areas of the pharma supply chain, offering industry insights across drug manufacturing, outsourcing, pharma i...

The new approval of Semeglee allows pharmacy-level substitution for Lantus across the US

Opportunities for contract development and manufacturing organisations (CDMOs) in China continue to grow but many questions remain over what the future of the sector will look like in the world's second largest pharmaceutical market.

Acquiring Xell AG will enable Sartorius to offer specialised media for manufacturing viral vectors

Transformative technologies and the opportunities afforded by the COVID-19 pandemic have spurred investment in the life sciences outsourcing sector, according to a panel of industry experts speaking at CPHI North America on Monday.

Two 2,000-liter single-use bioreactors to be installed as part of first phase expected to be operational in April 2023

The acquisition will add manufacturing footprint in the US enabling the company to develop its pipeline of novel cancer product candidates

Samsung to provide end-to-end CDMO services to advance Kineta's novel anti-VISTA antibody for the treatment of solid tumours

67,000-square-foot facility at Carlsbad campus is part of CDMO's investment strategy that addresses growing global demand for cell and gene therapies and vaccines

Acquisition will add West Coast coverage to the CDMO's East Coast and European capabilities and enhance its biologics formulation development and fill-finish network

The emerging biotech company unveils plans for a 1.2 million-sq. ft manufacturing facility in Yangzhou

A new media panel, gene kit and advanced resins help reduce manufacturing costs and increase the viability of gene therapies

Biogen’s Alzheimer’s drug Aduhelm has recently secured FDA approval to much fanfare. But do the benefits of the treatment justify the weighty $56,000 per year price tag?

Move is part of US$500 million five-year investment programme by Moroccan government and consortium to establish vaccine and biotherapeutic manufacturing capacity in the country

The CDMO's fivefold capacity increase will provide early preclinical through to commercialisation support

As part of $850 million investment package, CDMO will double US cell culture production for recombinant vaccines and increase UK gene therapy production tenfold

Facility is expected to come online in 2024 and will feature testing laboratories, manufacture of active pharmaceutical ingredients and manufacture and packaging of solid dosage pharmaceuticals and sterile products

The company will invest €400 million per year to advance mRNA technology beyond the pandemic

The investment will provide capacity to support current and future demands for the rapidly evolving cell and gene therapy sector

The agreement marks the second cell line development collaboration between the two companies

Drug categories impacted by travel restrictions expected to see higher sales levels in FY22

The French CDMO is also creating a new global resource for drug developers of ATMPs

XDC will provide a full range of development and manufacturing services in one centralised region

Biogen and Eisai's Aduhelm approved using the accelerated approval pathway after clinical trials demonstrated it reduced amyloid beta plaques by up to 71%

The expanded capacity and capabilities include the development of a dedicated Life Sciences Technology Center

The initial outbreak of the COVID-19 pandemic delayed merger and acquisitions in the pharma sector, but evidence points to an uptick in activity because the rationale for sealing deals hasn’t changed

The specialist CDMO receives manufacturing licenses from Switzerland and Denmark to supply customers with live biotherapeutic medicines

Pre-fillable syringes for intravenous drugs can replace traditional glass vials and ampoules, particularly in the time-sensitive and fast-paced world of emergency care

Coronavirus pandemic has exacerbated manufacturing capacity constraints, particularly in injectable dose and viral vector production, CPHI audience told

Strong and effective partnerships with CDMOs are essential to success due to the complexity of manufacturing processes

CDMO's site becomes the first vaccine production facility in South Korea to obtain EU GMP certification, allowing it to ship to Europe

The CDMO's expertise and capabilities a "perfect fit" for overcoming the challenges of manufacturing this complex molecule

New facility at Gosselies site will host commercial scale pDNA manufacturing as Catalent extends its cell and gene therapy footprint

The expansion will support a 50% increase in production of biotech's COVID-19 vaccine at its manufacturing site

Ahead of the session, How will the New Administration Impact the US Pharma Market? at CPHI Discover on Tuesday 18th May – global pharma’s largest ever virtual gathering – we spoke with one of the speakers, Nielsen Hobbs...

Transaction enables ArchiMed-backed biopharmaceutical services group to establish North American presence and expand activities with complementary services

Biotech ties up deal three days after World Health Organization issued an emergency use listing for the mRNA vaccine

Three additional drug substance manufacturing lines will be added to existing ones at Swiss site and are expected to be operational in early 2022

French company is now providing manufacturing capacity to support three different COVID-19 vaccines

What are the major implications of any drive to reshore US pharmaceutical manufacturing, given that current Asian domination is based on cost savings and capacity? We ask the experts...

The company will expand multiple facilities in Hyderabad and Bangalore to help reach its target of approximately 700 million doses per year of the COVID-19 vaccine

Ahead of CPHI Discover (17-28 May, 2021) - global pharma's largest ever virtual gathering - we spoke to CPHI Annual Report expert Vicky Xia, China Head at BioPlan Associates on the biologics trends she is seeing emerging in the contract services sp...

The expanded agreement will ensure Rocket Pharma's supply of lentiviral vectors across its pipeline

The expansions will enable the company's local customers to test equipment directly at the manufacturing site

New facility will be research partnering company’s sixth global site and will be dedicated to mammalian biologics

The antibody-based products will be expressed using Lonza's GS Xceed Gene Expression System

The company will invest €400 million in a new site to enable it to produce vaccines on a massive scale for Asia

The company's custom single run single-use fermenters supplied on fast-track schedule to support flexible manufacturing of plasmid DNA

The smallpox vaccine specialist will manufacture and deliver bulk drug substance of MVA-BN Filo vaccine during the second half of this year

The extended collaboration comes after reaching the initial milestone of producing 100 million doses

By integrating its HPAPI capabilities with those at ADC Biotechnologies' Deeside facility, small molecule CDMO will be able to offer the development and manufacturing of toxin linkers

The US facility in Rockville is expected to accelerate the company’s commercial-scale manufacturing timelines of gavo-cel

The CDMO will provide cell line development, process development, drug substance and drug product manufacturing for Pionyr’s monoclonal antibody candidate

Innovation in the design and development of large volume drug delivery devices can solve the challenge of accommodating the increasing trend towards patient self-administration and home care while at the same time ensuring that drugs that require intra...

CDMO subsidiary Fujifilm Diosynth Biotechnologies will operate the site which is expected to be operational in 2025

Multinational makes ‘difficult decision’ to halt presence in Chinese biosimilars market five years after $350 million investment

Despite COVID-related challenges and supply chain issues, the CDMO's $240 million new facility is on target to open next year

Regulators stress temporary halt is precautionary measure and that there is currently no evidence linking the shot to adverse events

In this special roundtable podcast exploring potential opportunities in a post-vaccinated world, we are joined by a panel of three world class experts – Bikash Chatterjee, CEO of Pharmatech Associates; Parrish Galliher, Managing Director, Bi...

Biologic products advance through clinical development with a higher success rate than traditional small molecules, this new analysis of clinical development success from Informa Pharma Intelligence, the Biotechnology Industry Organization and the...

Funding from BARDA helps the company to adapt and make available a number of existing manufacturing facilities for the production of SARS-CoV-2 vaccines and medicines

The addition further strengthens WuXi's cell and gene therapy service offerings for global customers and will be Wuxi ATU's first facility in Europe

This transaction complements Pharmaron’s recent acquisition of Absorption Systems in the US for building an integrated cell and gene therapy services platform

The company acquires a pDNA CDMO and launches pDNA development and manufacturing services at its Rockville, Maryland facility

The new site will be equipped to enable quick ramp-up of capacity for clinical and commercial cell therapy products

The CDMO will manufacture recently FDA-approved Lupkynis as a softgel dosage form at its St Petersburg, Florida, facility

The manufacturing agreement includes process development for scale-up and technology transfer with the goal of supplying Phase II and III clinical studies

Biotech will manufacture shots with partner SII for equitable vaccine distribution programme, COVAX

The company's additional production capacities are scheduled to go into operation in May 2021

The agreement allows the CDMO to "stay on the forefront of emerging indications and cell types"

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

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

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