Manufacturing mix-up could blunt supply boost from J&J vaccine

Bio Pharma Dive

One vaccine batch being manufactured for J&J by Emergent Biosolutions failed quality checks, reportedly ruining material sufficient for up to 15 million doses

FDA scolds Mylan for 'repeated' manufacturing problems

Bio Pharma Dive

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

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Xelum – Excelling in Continuous Manufacturing

Syntegon Technology Pharma Blog

Solid Dosage Continuous Manufacturing Oral Solid Dosage ShapingTheFuture Syntegon Xelum

Axovant shares sink on manufacturing delay for Parkinson's gene therapy

Bio Pharma Dive

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

Novartis joins Sanofi in aiding manufacture of coronavirus vaccines

Bio Pharma Dive

A deal to fill vials of Pfizer and BioNTech's vaccine could be the first of several Novartis signs to help others make COVID-19 treatments

Eschbach: better communication boosts pharma manufacturing

Outsourcing Pharma

A leader from the pharma software solutions provider suggests streamlining communication between shifts can avoid manufacturing snags. Contract Manufacturing & Logistics

PwC joins Medicines Manufacturing Innovation Centre

Outsourcing Pharma

The global professional services firm has signed on the newest partner in the collaboration, aimed toward promoting innovation in pharma manufacturing. Contract Manufacturing & Logistics

COVID-19 underscores need to boost pharma manufacturing in emerging markets

Pharma Phorum

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.

Lilly hires consultant to help fix issues at COVID-19 drug manufacturing plant

Bio Pharma Dive

The New Jersey facility that ran afoul of FDA manufacturing standards is one of several Lilly is using to produce coronavirus antibody drugs

COVID-19 Stimulus Legislation Will Cost OTC Manufacturers

Camargo

The post COVID-19 Stimulus Legislation Will Cost OTC Manufacturers appeared first on Camargo. Tucked away in the nearly 900 pages of the Coronavirus Aid, Relief, and Economic Security (CARES).

Continuus lands $69.3m US drug manufacturing contract

Outsourcing Pharma

The small-molecule pharmaceuticals manufacturer secured a DoD/HHS government contract to manufacture critical medicines, including a COVID-19 treatment. Contract Manufacturing & Logistics

Takeda adds to cell therapy push with new manufacturing site

Bio Pharma Dive

The Japanese drugmaker has made cell therapy a focus, advancing three experimental cancer treatments into clinical testing with plans for two more

AstraZeneca broadens coronavirus vaccine manufacturing deal with Catalent

Bio Pharma Dive

Catalent, which is already helping the British pharma make its vaccine, will now add key services from a Maryland gene therapy plant

Why cell therapy manufacture is a team sport

Pharma Phorum

Louis van de Wiel, Vice President, Site Head EU Manufacturing, Kite, a Gilead Company, reveals the complexity that sits behind the process of individualised cell therapy – and why team culture makes it work. The post Why cell therapy manufacture is a team sport appeared first on.

Good Manufacturing Practice (GMP)

Syntegon Technology Pharma Blog

Pharma Services Qualification/Validation

Novavax boosts coronavirus vaccine manufacturing capacity as key trial nears

Bio Pharma Dive

The Serum Institute of India, a go-to partner for coronavirus vaccine makers, will help Novavax boost capacity to levels matching its larger rivals

A closer look at the manufacturing scale-up hastening the coronavirus vaccine push

Bio Pharma Dive

The U.S. is now averaging more than 2 million doses given each day, a pace that will help President Joe Biden meet his target of 100 million shots in 100 days well ahead of schedule

FDA unexpectedly rejects Alkermes schizophrenia drug, citing manufacturing concerns

Bio Pharma Dive

Though Alkermes believes it can quickly resolve the issues cited by the agency, the complete response letter nonetheless delays approval of a drug that's critical to the company's hopes of a turnaround

Harnessing Nature for Faster mRNA Vaccine Manufacturing

BioSpace

Manufacturing capacity is often decried as a major bottleneck in administering COVID-19 vaccines to a global population of 7.8 billion. For mRNA vaccines, the bottleneck is the availability of raw materials, not bioreactors

BioNTech to buy manufacturing plant from Novartis to bolster vaccine supply

Bio Pharma Dive

The Novartis plant will help BioNTech and partner Pfizer make 750 million doses of their shot per year, and become one of the largest messenger RNA manufacturing sites in Europe

RNA 149

Arranta Bio set to boost manufacturing for growing pipeline of microbiome drugs

Bio Pharma Dive

The contract manufacturer aims to capitalize on progress for microbiome-based therapies, a field that's been buoyed by some recent clinical successes

J&J manufacturing delays hit US vaccine rollout

Pharma Phorum

The rollout of the US COVID-19 vaccination programme slowed up this week because manufacturing delays mean no new doses of the recently approved Johnson & Johnson vaccine are available. The post J&J manufacturing delays hit US vaccine rollout appeared first on.

GSK to help manufacture Novavax COVID-19 vaccine

BioPharma Reporter

GSK will help manufacture up to 60 million doses of Novavaxâs COVID-19 vaccine from its facility at Barnard Castle in the UK, with doses to be distributed in the country.

Biden Should Boost Covid Vaccine Supply With New Manufacturing Plan

NY Times

Shortages Vaccination and Immunization Coronavirus (2019-nCoV) Factories and Manufacturing Drugs (Pharmaceuticals) Acquired Immune Deficiency SyndromeTwo decades ago, the U.S. launched a program to help supply the world with H.I.V. medication. It should take a similar approach to Covid.

Benefits of Third Party Manufacturing of Pharmaceuticals

Fossil Remedies

ADVANTAGES OF THIRD PARTY MANUFACTURING IN PHARMA INDUSTRY. Amongst various business models used by people in the pharma manufacturing niche, third-party manufacturing is popular. Many people know that the third-party business model gives you a chance to manufacture the products even if you do not have adequate finance. The third-party pharma manufacturing model makes the whole process cost-effective.

Fund opens to boost UK life sciences manufacturing

Pharma Times

The £20 million fund will boost the UK's life sciences manufacturing capabilities, creating new economic opportunities and highly skilled jobs

Altasciences' comprehensive, integrated solution for clinical supply manufacture

Bio Pharma Dive

Integrated CRO/CDMO solutions for accelerated and more efficient early drug development programs

Abzena Plans $200 Million Manufacturing Biologics Facility in N.C.

BioSpace

Abzena is opening another manufacturing site, its sixth in a global network. This morning, the partner research organization announced it would build a $200 million facility in Sanford, N.C.

India's role in coronavirus vaccine manufacturing grows with new deals

Bio Pharma Dive

The Serum Institute, one of the world's largest vaccine producers, licensed Novavax's experimental shot, while Wockhardt signed on with the U.K. to help make AstraZeneca's candidate

Telix Pharmaceuticals and Grand River Aseptic Manufacturing Complete Agreement for Commercial Manufacturing of Illuccix®

BioTech 365

Telix Pharmaceuticals and Grand River Aseptic Manufacturing Complete Agreement for Commercial Manufacturing of Illuccix® Telix Pharmaceuticals and Grand River Aseptic Manufacturing Complete Agreement for Commercial Manufacturing of Illuccix® MELBOURNE, Australia and INDIANAPOLIS, March 30, 2021 (GLOBE NEWSWIRE) — Telix Pharmaceuticals … Continue reading → GlobeNewswire

Redhill expands manufacturing for COVID-19 candidate

Pharma Times

Company signs deals with two specialist pharmaceutical manufacturers

CPV and AI: The Formula To Succeed In Biopharmaceutical Manufacturing

XTalks

To achieve transparency and actionability of data, pharmaceutical companies are evolving their manufacturing processes by digitalizing the data from all of their equipment. Learn more by watching this webinar on-demand: CPV + AI: The Formula To Succeed In Biopharma Manufacturing.

BioNTech acquires German manufacturing site to boost COVID-19 vaccine production

BioPharma Reporter

BioNTech will acquire Novartisâ GMP certified manufacturing facility in Marburg, Germany: with the site set to become one of the largest mRNA manufacturing plants in Europe.

Emerson, Integra CMS collaborate on continuous pharma manufacturing technology

Outsourcing Pharma

The two firms are joining forces to help life-sciences customers speed up adoption of continuous manufacturing in pharmaceutical processes. Contract Manufacturing & Logistics

Novartis Closes Colorado Gene Manufacturing Site 14 Months After Acquisition

BioSpace

In 2019, Novartis subsidiary AveXis announced it acquired a manufacturing facility in Colorado to provide additional production capacity for Zolgensma.

Abzena choses North Carolina for new $200m biologics manufacturing site

BioPharma Reporter

Global Partner Research Organization Abzena will build a new GMP manufacturing facility in Sanford, North Carolina. Bio Developments

Grand River Aseptic Manufacturing tackles unique expansion

Outsourcing Pharma

Contract Manufacturing & LogisticsWhen growing market demand moved the Michigan CDMO to expand, it opted for a novel design-construction approach to building bigger digs.

DFE Pharma: adoption of continuous manufacturing on the rise

Outsourcing Pharma

Contract Manufacturing & LogisticsAccording to representatives from the pharma solutions provider, incorporation of CM processes, after a slow period, is expanding across the industry.

2nd Manufacturing Assets & Facility Management in Pharma (MAFM) Summit

Pharma Phorum

Twenty-twenty has demonstrated the need for a 24/7 , reliable manufacturing environment. Implement smart asset solutions to reduce COGs such as lean manufacturing and total productive maintenance. Events Partner Content pharma manufacturing

How Smaller Food Manufacturers Surpassed Big Food Brands During the Pandemic

XTalks

Whether it was ordering meal kit boxes, having ready-made meals delivered or trying out niche direct-to-consumer (DTC) brands, smaller food manufacturers gave Big Food a run for its money — and they show no signs of slowing down.

How Smaller Food Manufacturers Surpassed Big Food Brands During the Pandemic

XTalks

Whether it was ordering meal kit boxes, having ready-made meals delivered or trying out niche direct-to-consumer (DTC) brands, smaller food manufacturers gave Big Food a run for its money — and they show no signs of slowing down.

Pfizer inks manufacturing deal with Gilead for COVID-19 med remdesivir

Pharma Times

Pfizer becomes one of multiple external manufacturing organisations supporting scale-up of treatment

An Indiana startup aims to boost the US drug manufacturing push

Bio Pharma Dive

Incog BioPharma Services has become the latest entity to sprout up as part of a concerted U.S. effort to onshore production of pharmaceuticals