Pharmaceutical Technology

JULY 14, 2022

Regulatory decisions have a ripple effect, first affecting the pharma sponsors, and then the companies tasked to manufacture the drug. Pharmaceutical Technology looks at drugs and biologics with recent regulatory verdicts that will likely impact manufacturing volumes.

Manufacturing 130

Manufacturing Drugs Vaccination Vaccine 130

Pharmaceutical Technology

AUGUST 16, 2022

Large (market cap $10–100bn) and mega-cap (market cap >$100bn) sponsors also require contract manufacturers and packagers with specialist injectable capabilities in the case of cell and gene therapies, as shown in the report titled Contract Injectable Packaging Trends in the Bio/Pharma Industry (August 2022).

Gene Therapy 162

Gene Therapy Packaging Packaging Contract Packaging 162

Pharmaceutical Technology

JULY 15, 2022

The state plans to work directly with a contract manufacturing organization (CMO) to manufacture low-cost insulin. The documents state that a partnership with a CMO would be cheaper than the state directly manufacturing insulin. Prices would be “a fraction of the $300 per vial prices charged by insulin manufacturers.”.

Insulin 328

Insulin Manufacturing Contract Manufacturing Production 328

Pharmaceutical Technology

SEPTEMBER 8, 2022

Pharmaceutical solid dosage forms are the most popular in the pharmaceutical industry and are one of the most used drug delivery methods across patient groups. Find the leading pharmaceutical solid dose manufacturing companies in contract marketing.

Manufacturing 100

Manufacturing Marketing Contract Manufacturing Containment 100

Roots Analysis

APRIL 15, 2024

These complex entities, such as antibodies, antibody drug conjugates, cell therapies, gene therapies, and therapeutic proteins, are highly specific molecules that are designed to precisely target biomarkers associated with a particular disease pathway.

Manufacturing 40

Manufacturing Production Contract Manufacturing Contamination 40

Pharmaceutical Technology

NOVEMBER 22, 2022

Despite China producing a significant proportion of the world’s API supply (mostly small molecule), it manufactures relatively few biosimilar and innovator drugs and no cell and gene therapies for the western markets of Europe and the US despite investments and an increasing number of startups to improve innovative manufacture.

Manufacturing 162

Manufacturing Gene Therapy Gene Contract Manufacturing 162

Pharmaceutical Technology

JULY 29, 2022

Pfizer (New York, New York) and Moderna’s (Cambridge, Massachusetts) Omicron-specific Covid-19 vaccines are in late-stage development, have demonstrated good efficacy against the variant and will likely be available to the public later this year to provide an additional booster and increase demand for injectable manufacturing.

Manufacturing 130

Manufacturing Vaccination Vaccine Packaging 130

Pharmaceutical Technology

JUNE 14, 2023

Navigating the complexities of pharma and biotech packaging services can be difficult. With the growing number of complex therapies that require specialized packaging and handling requirements, selecting the right contract packaging organization (CPO) involves evaluating what services and additional benefits they can bring to your business.

Contract Packaging 130

Contract Packaging Packaging Packaging Development 130

Outsourcing Pharma

OCTOBER 11, 2021

Organizers of the drug delivery and packaging event have shared an industry report that reveals what is likely to push innovation forward in the future.

Drug Delivery 52

Drug Delivery Packaging Packaging Drugs 52

Camargo

JANUARY 19, 2021

On the other hand, an NDA for a drug improvement product utilizing the 505(b)(2) pathway typically has a Phase 1 bridging study, for which the drug product and API generally need to be at the to-be-manufactured stage. Additional requirements depend on the type of drug, indication, review division, and clinical program.

Production 135

Production Branding Contract Manufacturing Manufacturing 135

Drug Discovery World

FEBRUARY 22, 2023

Advances in new manufacturing technology accelerate Back in 2019 I wrote a paper about transforming the drug life cycle, which included what I felt were the opportunities and the challenges that were going to affect the pharmaceutical sector over the next few years.

Development 52

Development Drugs Manufacturing Contract Manufacturing 52

Pharmaceutical Technology

AUGUST 30, 2022

On 9 May this year, Merck & Co (Kenilworth, New Jersey) entered an agreement with Oswaldo Cruz Foundation (Fiocruz) (Rio de Janeiro, Brazil) for the manufacturing of the Covid-19 antiviral molnupiravir. Eurofarma will obtain the drug product from facilities in the US. French and Italian manufacturers have two companies in Brazil.

Manufacturing 195

Manufacturing Marketing Pharma Companies Vaccination 195

Pharmaceutical Technology

JULY 4, 2022

Compared with other emerging pharmaceutical markets (such as India and China, covered in previous Emerging Market Outsourcing Reports), Russian facilities lack many US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approvals, meaning Russian manufacturing is more focused on the domestic market.

Pharma Production 305

Pharma Production Production Clinical Trials Clinical Trials 305

The Pharma Data

NOVEMBER 5, 2020

Food and Drug Administration (FDA) granted Breakthrough Therapy designation for the treatment of patients 12 years and older with eosinophilic esophagitis (EoE). In July 2020 , the Company announced an agreement whereby the Company was awarded a $450 million contract to manufacture and supply REGN-COV2 to the U.S. government.

Sales 52

Sales Production Manufacturing Antibody 52

XTalks

FEBRUARY 11, 2021

The vials are inspected, packaged, labeled and frozen in a subzero -70 degrees C freezer. Apart from its own contracted manufacturing facilities, unexpected production help has been coming in from rival drug-makers including Sanofi, Bayer and Novartis who are pitching in to produce millions more doses of BNT162b.

Manufacturing 52

Manufacturing Vaccination Vaccine DNA 52

Pharmaceutical Technology

MARCH 21, 2023

Most pharmaceutical and biotech companies outsource certain production tasks to contract manufacturing organizations (CMOs). Based on the individual contract, these CMOs manufacture small molecules or biological active pharmaceutical ingredients (APIs), as well as packaging material, and are charged with other related functions.

Manufacturing 147

Manufacturing Drugs Packaging Packaging 147

Pharmaceutical Technology

JANUARY 15, 2023

In order to get a therapy to the market, pharma companies often outsource the drug manufacturing to specialist contract manufacturing organizations (CMOs). While Catalent Inc and PCI Pharma Services are in charge of the solid dose and packaging of Lupkynis, Lonza is manufacturing the small molecule API.

Manufacturing 130

Manufacturing Packaging Packaging Contract Manufacturing 130

Pharmaceutical Technology

JANUARY 12, 2023

PM: Lyophilization is widely used in the pharmaceutical and biotech industry for small molecule drug products, vaccines, antibodies, and other biological material. That would not allow sufficient time to manufacture, package and distribute before half of the content was degraded. A great example is aspirin. Free eBook.

Production 130

Production Contamination Development Manufacturing 130

Pharmaceutical Technology

FEBRUARY 27, 2023

Manufacturing a drug therapy usually involves several different stakeholders. Baxter Biopharma Solutions has been contracted for the ADC’s parenteral manufacture and packaging. Regulatory decisions by the EMA for select therapies from late December to late January, and the CMOs contracted to manufacture them.

Manufacturing 130

Manufacturing Drugs Packaging Packaging 130