FDA Law Blog

APRIL 25, 2024

This Revised Draft Guidance provides considerations for manufacturers, packers or distributors (dubbed “firms”) of prescription biological reference products, biosimilar products, and interchangeable biosimilar products presenting data and information about such products in promotional materials in a truthful and non-misleading way.

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Drug Discovery World

MARCH 14, 2023

By partnering with a supplier like Thermo Fisher Scientific, you gain access to end-to-end mRNA workflow solutions, products with proven quality, and technical professionals who can proficiently support you throughout your process development and scale-up stages.

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Drug Discovery World

OCTOBER 24, 2022

This free webinar, hosted by DDW and supported by Catalent, will be presented by Matthias Craig, Senior Manager Product Development, Catalent. You will learn: Key considerations during plasmid production including design and screening systems, processing, and analytical testing. Register for free. Register for free. .

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Pharmaceutical Technology

AUGUST 24, 2022

To reduce batch-to-batch variations, the preferred control parameter is ribbon strength. Based on the idea that ‘consistent density means consistent product quality’, the at-gap density can also be used for development and scale-up. Figure 1: Compressibility and Bondability plot of tablets with MCC and 0.5% Conclusion.

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BioPharma Reporter

DECEMBER 11, 2023

Naobios, a CDMO providing bioprocess development and GMP production of clinical batches of virus-based products, has received a $1.87 million grant from the Bill & Melinda Gates Foundation to support its vaccine development efforts.

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Camargo

NOVEMBER 15, 2021

It created the possibility of more easily obtaining information to support new product indications or to help with post-approval study requirements. In October, the FDA took a step towards clarifying these questions with a guidance called “ Data Standards for Drug and Biological Product Submissions Containing Real-World Data.”.

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pharmaphorum

DECEMBER 4, 2020

Pfizer slashed its production targets for its COVID-19 vaccine because of a lack of raw materials for its supply chain, according to press reports. Modifications to Pfizer’s production lines are complete and finished doses are being made at a rapid pace.

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Pharmaceutical Technology

AUGUST 10, 2022

Working with a contract manufacturing organization (CMO) in the pursuit of bringing a new product to market can deliver a range of significant benefits. They are also likely to have already worked with a similar molecule and can even anticipate the hurdles a company may face in production. Proven results??. Process Flow diagram?

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Scienmag

MARCH 1, 2021

Making cheese leaves a lot to chance as a batch could be ripened for months or even years before a problem is discovered, which could send a prized batch of cheddar to be sold […]. Researchers are helping take the guesswork out of cheese manufacturing by using science to better predict and control the ripening process.

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Roots Analysis

APRIL 15, 2024

The production of biologics involves high degree of fragility and sensitivity involving the need for complex manufacturing capabilities, such as fermentation, aseptic fill finish , adequate storage with controlled temperatures and analytical testing to offer quality products.

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Pharma Mirror

SEPTEMBER 22, 2021

Nantes, France, Naobios, a CDMO (Contract Development and Manufacturing Organization) providing bioprocess development and GMP production of clinical batches of viral vaccines BSL2/BSL3, oncolytic viruses and viral vectors, today announces the next phase in its partnership with FluGen, Inc.,

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BioPharma Reporter

FEBRUARY 13, 2023

Genentech is to build a new biologics facility at its Oceanside, California campus that it says will be at the forefront of next-generation manufacturing and environmentally sustainable production for small-batch commercial biologics.

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BioPharma Reporter

APRIL 6, 2021

Emergent BioSolutions Inc yesterday reported that is on target in terms of all its commitments for COVID-19 vaccine production; it also reaffirmed its financial guidance, after a production issue at its Baltimore plant last week saw a massive batch of Johnson & Johnsonâs COVID-19 vaccine doses spoiled.

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pharmaphorum

AUGUST 12, 2022

The COVID-19 pandemic led to skyrocketing demand for some products while simultaneously constraining supplies due to logistical breakdowns and protectionist practices. The logic of outsourcing production to other countries, primarily China, suddenly looked dubious as Western countries struggled to import the drugs they needed.

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pharmaphorum

MARCH 16, 2021

European regulators questioned the integrity of early batches of Pfizer/BioNTech’s mRNA vaccine, although the matter was resolved before approval, according to information leaked online following a cyberattack. Early commercial batches of Pfizer/BioNTech’s COVID-19 vaccine had lower than expected levels of intact mRNA.

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XTalks

FEBRUARY 8, 2021

While the approval pathway for biosimilar products was established 12 years ago, there are still misconceptions about how biosimilars are approved, biosimilarity versus interchangeable status and which patients can be treated with biosimilars. What is an Interchangeable Biological Product? What is a Biosimilar?

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STAT News

JANUARY 6, 2023

Continuous manufacturing produces a drug product from start to finish through a nonstop, integrated assembly. In contrast, most of the pharmaceutical industry currently uses batch manufacturing, which involves producing a finished drug product through multiple distinct steps in series.

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Pharmaceutical Technology

MARCH 3, 2023

Alex and his team have the significant responsibility of managing various commercial programs for more than 40 marketed products. The Halle customer service team is a “one-stop-shop” for client requests when it comes to commercial drug product manufacturing,” explains Dragitsch.

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Pharmaceutical Technology

JUNE 23, 2022

As more drugs are approved with continuous manufacturing, this production method is becoming increasingly mainstream. Allowing for real-time process monitoring during drug production can help with continuous manufacturing. The US House of Representatives separately passed a bill on continuous manufacturing on 19 October last year.

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Pharmaceutical Technology

MAY 15, 2023

It will also enable NUCLIDIUM to achieve a sustainable supply of ⁶¹Cu in the US for its proposed clinical trials and upcoming commercialised products. PharmaLogic will use its production facilities across the US to create the products, with the first batch to be produced at its location in Los Angeles, California, in 2023.

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XTalks

FEBRUARY 21, 2022

BioNTech announced its new vaccine manufacturing approach in Africa where the company will ship modular factories, called the BioNTainer, to the continent to enable domestic production of the vaccines to help increase supplies. Related: BioNTech to Build First mRNA Vaccine Production Plant in Africa. Photo source: BioNTech.

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Pharmaceutical Technology

NOVEMBER 24, 2022

Additionally, the transfer of technology will build and validate capacity for scaling up Good Manufacturing Process (GMP), domestic production of clinical trial products and end-to-end vaccine manufacturing in Africa for regional and global use.

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Outsourcing Pharma

JANUARY 16, 2023

The FDA found traces of a nitrosamine in batches of vonoprazan, delaying the commercialization of the product and its application for an additional indication.

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Pharmaceutical Technology

AUGUST 12, 2022

And while the gloomiest predictions around medicine shortages do not appear to have come to pass, shortfalls in drugs like HRT products have been partially attributed to Brexit. Changes to batch testing requirements. One looming issue for the pharma industry is the upcoming December 2022 deadline around batch testing.

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Camargo

MARCH 10, 2021

Through this process, a donor site (either a product’s sponsor or a manufacturing site) transmits proprietary knowledge and experience about a product, the associated manufacturing processes, and/or the relevant analytical methods to a receiving manufacturing site. Technology Transfer Goals.

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pharmaphorum

NOVEMBER 27, 2022

Supply chain issues have been rife in pharmaceuticals for a while, but current socio-economic challenges such as the conflict in Ukraine and the COVID-19 pandemic have led to extended wait times and higher prices for thousands of products. Reducing capacity issues. Cutting down on safety stock.

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Pharmaceutical Technology

JUNE 19, 2023

Further compounding the complexity is the highly temperature-sensitive nature of these products, meaning any hiccup faced when processing products outside of their freezer banks can have a serious, knock-on effect. You have very little supply and the product is incredibly temperature sensitive,” explains MacNeir. “If

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Pharma Mirror

JUNE 23, 2021

Vectura Group plc, an industry leading inhalation CDMO, today announced it has signed an agreement with Incannex Healthcare Limited, an Australian cannabinoid medicines development company, to provide pre-clinical development services for IHL-216A, Incannex’s proprietary inhaled drug product for the treatment of traumatic brain injury (TBI).

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STAT News

SEPTEMBER 21, 2022

Following a recent month-long inspection, the agency scolded Catalent for various problems, such as failing to investigate unexplained discrepancies in batches of products and to ensure that product sampling and testing met quality control criteria.

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Pharmaceutical Technology

MARCH 10, 2023

Freeze drying is a crucial technique to prolong the shelf life of pharmaceutical products. Also known as lyophilisation, the technique stabilises and preserves sensitive products such as biologics, and diagnostic kits, in a permanently storable state. The process eliminates the disadvantages of conventional drying methods or freezing.

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Pharmaceutical Technology

AUGUST 10, 2022

The takeover of Metrics will bolster the expertise of Catalent in the development of integrated oral solid formulation, production and packaging to aid customers in streamlining and expediting their programmes. It will also aid in expanding the capacity of Catalent to manage highly potent compounds.

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XTalks

AUGUST 17, 2023

Based in San Leandro, California, New Culture currently works with an external partner to produce fermentation batches of casein, a protein found in milk. These batches yield mozzarella that has the familiar qualities of conventional dairy cheese — melting, stretching and bubbling — for about 25,000 pizzas per year.

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Protein Production Manufacturing 98

Drug Discovery World

NOVEMBER 23, 2022

One critical bottleneck in Cell and Gene Therapy (CGT) manufacturing is the production of high-quality plasmid DNA (pDNA), a vital building block for mRNA-based vaccines, viral vector-based cell or gene therapies that require pDNA as a starting material.

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Drug Discovery World

NOVEMBER 14, 2022

The webinar will be presented by Matthias Craig, Senior Manager Product Development, Catalent and will take place on November 17, 2022, 3pm GMT, 4pm CET. You will learn: Key considerations during plasmid production including design and screening systems, processing, and analytical testing. Register for free.

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Drug Discovery World

NOVEMBER 7, 2022

Register now to attend this free webinar, hosted by DDW and supported by Catalent, which will be presented by Matthias Craig, Senior Manager Product Development, Catalent. You will learn: Key considerations during plasmid production including design and screening systems, processing, and analytical testing. Register for free.

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Pharmaceutical Technology

JULY 4, 2022

Under the initial deal, the production of Covid-19 vaccines at the Oxbox facility of Oxford Biomedica is anticipated to conclude in the last quarter of this year. Oxford Biomedica has entered a new three-year Master Services & Development Agreement to potentially manufacture AstraZeneca UK’s Covid-19 vaccines in the future.

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Drug Discovery World

NOVEMBER 4, 2022

One critical bottleneck in Cell and Gene Therapy (CGT) manufacturing is the production of high-quality plasmid DNA (pDNA), a vital building block for mRNA-based vaccines, viral vector-based cell, or gene therapies that require pDNA as a starting material. . It will take place on November 17, 2022, 3pm GMT, 4pm CET. Register for free.

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