Addressing manufacturing challenges in gene therapy development
Bio Pharma Dive
MARCH 20, 2023
As new gene therapies are developed to treat a growing number of indications, patients may soon have access to novel treatment options and potential cures
Manufacturing Related Topics 
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Incannex partners with Catalent to manufacture psilocybin
Pharmaceutical Technology
MARCH 6, 2023
Incannex Healthcare has collaborated with New Jersey-based pharma company Catalent for the development and manufacturing of a cGMP-grade psilocybin drug product for clinical trials and potential commercial use.
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Novo obesity drug sales lag as manufacturing problems persist
Bio Pharma Dive
NOVEMBER 2, 2022
Manufacturing problems continue to weigh on Novo’s Wegovy launch as competition looms from Eli Lilly’s fast-selling diabetes medicine Mounjaro
Novartis funnels $300M into early biologic drug manufacturing
Bio Pharma Dive
SEPTEMBER 12, 2022
The investment is meant to improve Novartis’ capacity for developing and manufacturing biologic medicines that make up a larger share of its pipeline
Pharma manufacturing can digitalise its way round the next crisis
Pharma Phorum
DECEMBER 29, 2022
The turbulence of the last three years can make it seem as though pharma manufacturers have been operating in an atmosphere of non-stop crisis. The post Pharma manufacturing can digitalise its way round the next crisis appeared first on.
High interest rates will reduce investment in pharma contract manufacturers
Pharmaceutical Technology
FEBRUARY 24, 2023
Pharma manufacturers will likely be unable to invest as much in innovative capabilities as they did previously due to the current environment of high inflation and quickly rising interest rates. Instead, many manufacturers will refocus on operational efficiency in the coming months.
Call to arms as UK falls back in medicines manufacturing
Pharma Phorum
JANUARY 24, 2023
Drastic steps need to be taken if the UK is to reverse a steep decline in medicines manufacturing in recent years, according to a cross-industry coalition. The post Call to arms as UK falls back in medicines manufacturing appeared first on.
The Mexico pharma market: growth factors and advantages for manufacturing
Pharmaceutical Technology
DECEMBER 15, 2022
In addition, more than $15.48bn in pharma sales were recorded in Mexico in 2021, and the country offers a strong manufacturing base for antibiotics, analgesics, and antiparasitics. Mexico is increasingly attracting international pharma companies and contract manufacturers.
Manufacturing mix-up could blunt supply boost from J&J vaccine
Bio Pharma Dive
APRIL 1, 2021
One vaccine batch being manufactured for J&J by Emergent Biosolutions failed quality checks, reportedly ruining material sufficient for up to 15 million doses
Resolving challenges with product recovery in biopharma manufacturing
Pharmaceutical Technology
FEBRUARY 28, 2023
Breakthroughs in therapies containing monoclonal antibodies (mAbs) are showing ever-greater potential in treating a range of diseases, alongside biopharma manufacturers facing the challenge of keeping up with demand for production while controlling costs.
California’s low-cost insulin plans receive $100m manufacturing boost
Pharmaceutical Technology
JULY 15, 2022
Insulin prices made the headlines again as California governor Gavin Newsom announced plans on 7 July for the state to manufacture low-cost insulin. The state plans to work directly with a contract manufacturing organization (CMO) to manufacture low-cost insulin.
Takeda set to build $764m manufacturing facility in Japan
Pharmaceutical Technology
MARCH 24, 2023
Takeda has unveiled plans to invest almost $764m (JPY100bn) to construct a new manufacturing facility for plasma-derived therapies (PDTs) in Osaka, Japan. The new facility represents the company’s largest-ever investment in the expansion of manufacturing capacity in the country.
Sustainable manufacturing
Scienmag
JANUARY 11, 2022
Social & Behavioral Science manufacturing sustainableReducing the world’s reliance on petroleum and natural gas is a worthy goal, one that could help us achieve a smaller carbon footprint. It will, however, mean rethinking how we create many of the products in our everyday lives.
Continuous manufacturing adoption continues to rise: Pharmatech
BioPharma Reporter
MAY 4, 2022
Contract Manufacturing & LogisticsAn expert from Pharmatech Associates offers a glimpse into the evolution of CM and previews a lively discussion during the upcoming CPhI North America event.
ElevateBio finds a new manufacturing home and long-term gene therapy partner in Pittsburgh
Bio Pharma Dive
AUGUST 25, 2022
The biotech signed a 30-year deal with the University of Pittsburgh to establish a gene and cell therapy manufacturing hub that’s being built with a $100 million grant
New facility boosts UK’s cell and gene therapy manufacturing capacity
Pharmaceutical Technology
MARCH 10, 2023
On 10 March, the National Health Service Blood and Transplant (NHSBT) opened a new Clinical Biotechnology Centre (CBC) with the aim of improving the UK’s ability to develop and manufacture cell and gene therapies.
Bluebird preps for split by selling manufacturing plant to well-funded startup
Bio Pharma Dive
JULY 29, 2021
The startup manufacturing specialist National Resilience, which raised $800 million when it launched last year, will pay Bluebird $110 million for the North Carolina facility, bringing its North American network up to 10
Axovant shares sink on manufacturing delay for Parkinson's gene therapy
Bio Pharma Dive
OCTOBER 30, 2020
A longer-than-expected timeline for developing a new manufacturing process means a key study for Axovant's top gene therapy likely won't begin until 2022
Brazil: untapped market for big pharma manufacturing
Pharmaceutical Technology
AUGUST 30, 2022
International companies investing in the emerging market of Brazilian pharmaceutical manufacturing will see a higher return on investment than from developed market equivalents, if they choose to compete with local manufacturers to supply Brazil’s growing market and the greater South American region.
CMO Moves: Regulatory catalysts for drug manufacturing-October
Pharmaceutical Technology
OCTOBER 11, 2022
But successfully manufacturing that product after approval is key to making any dent in a company’s balance sheet. Pharmaceutical Technology takes a look at such regulatory calls since late August and in the month of September and the CMOs contracted to manufacture the approved therapies.
Digital CPV for Continuous Manufacturing
Fierce Pharma
MARCH 1, 2023
Digital CPV for Continuous Manufacturing jpiatt Wed, 03/01/2023 - 14:52
Artificial intelligence can elevate pharma manufacturing
Outsourcing Pharma
MAY 17, 2021
Contract Manufacturing & LogisticsAccording to a leader from industrial AI specialist AspenTech, AI can help avoid costly maintenance interruptions by predicting when upkeep is needed.
Gilead, having resolved manufacturing issues, forges ahead with HIV drug
Bio Pharma Dive
MAY 17, 2022
The company can now resume testing in nearly a dozen studies that were paused due to FDA concerns about interactions between the drug, lenacapavir, and the glass vials in which it was contained
Upsher-Smith opens contract manufacturing facility
Outsourcing Pharma
FEBRUARY 14, 2023
The company announces the completion of its greenfield facility that possesses manufacturing, packaging, and serialization capabilities. Contract Manufacturing & Logistics
iPSC Manufacturing Summit
Pharma Phorum
APRIL 25, 2022
With iPSCs exhibiting game-changing potential in the bid to develop an off-the-shelf therapy, the brand-new iPSC Manufacturing Summit is the only summit dedicated to solving the manufacturing, quality and analytical challenges hindering your iPSC-derived treatments from reaching patients.
Distributed Control System Facilitates Expansion for New Drugs Produced by Contract Manufacturing Organization
Pharma Mirror
DECEMBER 9, 2021
Combatting the pandemic has highlighted the importance of the partnership between biopharma organizations and the contract manufacturing organizations (CMOs) that must flexibly handle outsourced production, which can come suddenly and often must quickly be ramped up.
Pasithea agrees manufacturing deal with WuXi STA
Outsourcing Pharma
JANUARY 24, 2023
The CDMO will manufacture the API for the biotechâs lead drug candidate, ahead of plans to begin clinical trials. Contract Manufacturing & Logistics
CMO Moves: Regulatory catalysts for drug manufacturing – March 2023
Pharmaceutical Technology
MARCH 21, 2023
In such turbulent times, ensuring the most efficient and cost-effective manufacturing frameworks becomes even more important. Most pharmaceutical and biotech companies outsource certain production tasks to contract manufacturing organizations (CMOs).
DARPA selects continuous manufacturing partner
Outsourcing Pharma
NOVEMBER 4, 2020
The agency has chosen Continuity Pharma to aid in development and advancement of continuous manufacturing technology, with the help of a $1.5m Contract Manufacturing & Logistics
Sanofi revs up manufacturing with help from McLaren
Pharma Phorum
APRIL 26, 2022
French drugmaker wants the efficiency of its manufacturing operations to go up a gear, and has joined forces with Formula One racing team McLaren to make it happen. The post Sanofi revs up manufacturing with help from McLaren appeared first on.
FDA clears second Novartis plant for gene therapy manufacturing
Bio Pharma Dive
APRIL 5, 2022
The 170,000-square-foot plant located in North Carolina can now fulfill its primary function: producing commercial-grade Zolgensma, which has become one of the Swiss pharma's top-selling drugs
Novartis turns cell therapy skill into contract manufacturing deal
Bio Pharma Dive
MARCH 10, 2022
In an unusual arrangement, the Swiss pharma will make Carisma Therapeutics' experimental cell therapy at its Morris Plains factory, part of its plans to build up a CMO business
California to manufacture its own insulin, governor says
Bio Pharma Dive
JULY 11, 2022
Gavin Newsom announced a $100 million budget to create a production facility and to develop affordable insulin products, saying the medicines’ high cost “epitomizes market failures &rdquo
Cytovance Biologics and Phenotypeca partner for biopharmaceutical manufacturing
Pharmaceutical Technology
MARCH 13, 2023
Cytovance Biologics has entered a collaboration deal with Phenotypeca to enhance the development of saccharomyces cerevisiae strain for biopharmaceutical manufacturing.
FDA issues continuous manufacturing advice to build an agile pharma industry
Pharmaceutical Technology
MARCH 2, 2023
On 1 March, the FDA issued the International Council for Harmonisation (ICH) final guidance on the use of continuous manufacturing in drug production. Many pharmaceutical products are made through a step-by-step process known as batch manufacturing.
Lonza opens early-phase development and manufacturing facility in Oregon
Outsourcing Pharma
JUNE 14, 2022
The company has completed its early-phase development and manufacturing facility in Bend, giving it 11 processing suites focused on first steps into the clinic. Contract Manufacturing & Logistics
FDA scolds Mylan for 'repeated' manufacturing problems
Bio Pharma Dive
SEPTEMBER 3, 2020
Though it once had a glimmering manufacturing record, Mylan now finds itself in the crosshairs of the FDA. The agency is advising the company to quickly and comprehensively assess its global operations
Overcoming challenges with scalability in biopharma manufacturing
Pharmaceutical Technology
JANUARY 20, 2023
However, scaling processes up to a manufacturing scale is far from straightforward. The challenges with scaling up mAbs therapy production When developing a mAb therapeutic, there has traditionally been inconsistency between early lab processes, pilot processes and commercial manufacturing.
COVID-19 underscores need to boost pharma manufacturing in emerging markets
Pharma Phorum
MARCH 22, 2021
For the past year, life science companies around the world worked at breakneck speed to develop and manufacture safe and effective treatments to respond to the COVID-19 pandemic. His experience spans sales & marketing, business development, R&D, manufacturing and operations.
Intelligent digitalization can maximize manufacturing ROI: ACG
Outsourcing Pharma
SEPTEMBER 10, 2021
A leader from ACG Engineering shares insight on how âsmartâ drug manufacturing, accelerated by COVID-19, can best be put to work now and in months to come. Contract Manufacturing & Logistics
Medical Device Innovation Summit: India is poised to be a manufacturing hub for medical equipments and devices
Pharma Mirror
SEPTEMBER 4, 2020
From challenges like lack of regulatory systems to its new found potential of manufacturing indigenous products on a large scale, the summit successfully addressed discussions on new. Pharma Equipments Manufacturers & Agents India mdis Medical equipments and devices
What is Registration Drift in pharmaceutical manufacturing, and how can I avoid it?
Pharma Mirror
JUNE 24, 2021
By Dr Ash Ramzan, founder and principal consultant, Woodley BioReg During a pharmaceutical product’s lifetime, it’s widely known and accepted that manufacturing processes will drift within their specified ranges — typically due to equipment wear-and-tear and operator variance.
CPI and 24 partners open £88m manufacturing innovation center
Outsourcing Pharma
DECEMBER 6, 2022
The collaborators unveil the facility after combing ideas from pharma and technology sectors to develop more sustainable manufacturing processes. Contract Manufacturing & Logistics
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