Pharmaceutical Technology spoke with Andrew Anderson, Global Head Strategic Account Management and Mary Todas, Director Technical Development and Regulatory Affairs, both with Pfizer CentreOne, about best practices for API quality.
“Much of the world’s supply of pharmaceuticals depends on this critical aspect of the drug product supply chain, and manufacturers around the world shoulder a tremendous responsibility to assure the quantity, quality, and continuity of supply. Unfortunately, the world has seen the impact of quality-compromised API supply chains, resulting in injury and death, the worst possible of all patient outcomes.” Andrew Anderson, Global Head Strategic Account Management and Mary Todas, Director Technical Development and Regulatory Affairs.
ChargePoint Technology announced the acquisition of PuroVaso, a leader in the design, development, and manufacture of single-use containers, handling equipment and accessories for the pharma, biopharma and life science markets.
PuroVaso is a specialist in designing and manufacturing single-use disposables for the pharmaceutical industry. The company’s products are designed to the highest standards, and used in many pharma, biopharma, and life science clients’ facilities worldwide.
Nasal vaccines are commercially high risk, perhaps high reward
Dozens of intranasally delivered vaccines targeting SARS-CoV-2 are in development. Could they pave the way for widespread nasal vaccination in the future?
“I think the consensus right now is that intramuscular vaccines are going to have a really, really hard time reaching that milestone,” says Virologist Neeltje van Doremalen, an Associate Scientist at the National Institute of Allergy and Infectious Diseases (NIAID).
Pfizer and Moderna’s updated COVID boosters win FDA nods, with swift rollouts to follow
The FDA has given the all-clear to Omicron-targeted COVID-19 shots from Moderna and Pfizer-BioNTech. The pair of bivalent mRNA vaccines have scored emergency use authorizations as single-dose vaccinations to be given at least two months after primary or initial booster vaccination, the regulator said in a release.
“As we head into fall and begin to spend more time indoors, we strongly encourage anyone who is eligible to consider receiving a booster dose with a bivalent COVID-19 vaccine to provide better protection against currently circulating variants,” FDA Commissioner Robert Califf said in a statement.
LuinaBio: Ampersand adds another CMDO to the portfolio
Previously known as Luina Bio, AcuraBio is a microbial contract development and manufacturing organization (CDMO) with a 20 year history. It will now be rebranded as AcuraBio, following the acquisition of the firm by biotech investor Glenn Haifer and private equity firm Ampersand Capital Partners.
The new owners have not disclosed information about their plans for the CDMO, but they have announced that they plan to expand production facilities in Queensland, Australia.
Out-of-Stock – Authorizations for the temporary import and distribution of human medicines – COVID-19 Update. In measures to combat the Coronavirus (Covid-19 Ordinance 3), the Federal Council issues provisions designed to ensure the supply of important medical goods. Based on this ordinance, Swissmedic can approve the import of essentially identical medicinal products as a short-term solution for any temporary non-availability of medicinal products.
The Haemovigilance Annual report 2021 here suggests that a backlog in elective surgeries has caused an increase in reported transfusions.
Swissmedic approves first bivalent COVID-19 booster vaccine in Switzerland. Moderna’s Spikevax Bivalent Original/Omicron (mRNA-1273.214) is authorised from age 18.
The notification of suspected illegal trading in medicinal products products information sheet has been updated. The updates covers clarification of the criteria for cases notified in connection with mandatory notification where there is a suspicion of illegal trading in medicinal products.
Some developments of note in the contracting sector:
CMO/CDMO Market Application, Trends, Growth, Opportunities and Worldwide Forecast to 2030 – an increasing number of companies within the pharmaceutical sector have been considering contract manufacturing in response to the increasing demand for generic drugs and biologics.
Liminal BioSciences Announces Termination of Legacy CDMO Contract – The termination of the CDMO agreement is effective immediately.
Porton Advanced raises $80M for CGT CDMO Operations – Chinese cell and gene therapy (CGT) CDMO Porton Advanced Solutions has completed an $80M Series B round to expand its business into new markets.
Catalent prepped for two-third cut in COVID revenues – Increased cell and gene therapy, drug product, and drug substance demand will offset the considerable decline in COVID-19 revenues in FY 2023, says CDMO Catalent.
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