Monthly Archives - August 2020


FDA and BARDA to collaborate with Grifols on COVID-19 therapeutics

Grifols has entered a formal collaboration with the US Biomedical Advanced Research Development Authority (BARDA), Food and Drug Administration (FDA) and other Federal public health agencies to develop a plasma-derived COVID-19 therapeutic.

The company will leverage its expertise and resources for plasma collection to collect and process plasma from convalescent COVID-19 patients to create a hyperimmune globulin which it will support through pre-clinical and clinical studies. The collaborators hope to determine if an anti-SARS-CoV-2 hyperimmune globulin therapy can successfully be used to treat COVID-19 disease.

Grifols stated that it will use its network of FDA-approved plasma donor centres to test and qualify donors and collect their plasma; then process the plasma into hyperimmune globulin at its purpose-built facility in Clayton, North Carolina, US, and support pre-clinical and clinical studies to determine whether hyperimmune globulin made from the plasma of convalescent donors could be viable treatment for COVID-19 disease and as a platform for the treatment of future emerging infectious diseases.

According to the collaborators, the FDA is working to reduce unnecessary regulatory hurdles and ensure the therapy is approved as quickly as possible, if it meets the product safety and integrity requirements.

Alongside the hyperimmune globulin development, Grifols has also agreed to provide resources for utilising convalescent plasma for direct transfusion. The enterprise will provide their viral inactivation technology, methylene blue, to ensure any plasma units for use in transfusion do not carry active viral particles.

The collaborators hope that the use of both directly transfused, virally inactivated plasma and hyperimmune globulin could be utilised against the current COVID-19 pandemic and other future outbreaks of emerging viruses.

Simultaneously, Grifols is working on a clinical trial testing the efficacy and safety of inactivated plasma at treating COVID-19 in Spain. The company is also collaborating with Spanish hospitals to conduct a host of clinical studies on the use of other plasma-derived therapeutics, including intravenous immunoglobulin and alpha-1 antitrypsin, with the goal of proving their efficacy in the treatment of COVID-19.

The enterprise has also accelerated the development and validation of their transcription-mediated amplification (TMA) based diagnostic tool, which supposedly is able to detect COVID-19 with a sensitivity similar to or superior to polymerase chain reaction (PCR), the currently used screening method. The test will be performed on automatic instrumentation, with each unit able to run more than 1,000 samples per day and will be ready in the following weeks.


Ru-Pt conjugate drug could be the future for cancer therapies

Researchers combined cisplatin, an enhancer and a photodynamic therapy (PDT) drug into a single conjugate that had 10 times the efficacy in treating treatment resistant cancer cells. Chemists have designed a conjugate of three anti-cancer agents which can be administered as a single drug and has three modes of action in killing tumours. The aim was to create a drug that provides a simpler method for overcoming cancer resistance, by combining three of the most often combined agents – cisplatin, phenylbutyrate and a photodynamic therapy (PDT) drug. The design and pre-clinical testing of the conjugate drug, called Ru-Pt, was detailed in Angewandte Chemie. Ru-Pt combines cisplatin, the most frequently applied chemotherapy agent, phenylbutyrate, a chemical cisplatin enhancer and a PDT drug, a metal complex based on a ruthenium(II) ion. The result is a drug that can bind to DNA and distort its structure to trigger cell death and be activated by light to create a reactive oxygen species which can interfere with cell metabolism to cause death. “In clinical protocols, each drug is administered separately and may not reach the tumour at the same time or at a fixed ratio,” says Professor Gilles Gasser from the Paris Sciences et Lettres (PSL) University in Paris, France, who is one of the leading authors of the study. The idea of creating the conjugate was that it would enable the three drugs to travel through the bloodstream intact and enter their target tumour cells, which would reduce side effects and the need to adjust drug dosages. According to the team, they designed the phototherapeutic Ru(II) portion to be excited by a deep red laser light which penetrates deeply into biological tissue. The Pt, or cisplatin and phenylbutyrate component, is a pro-drug, activated by parts of the cells to limit off-target and systemic effects. The two therapeutic components are joined by a molecular spacer: “The correct spacer length was critical to ensure that both drug compounds will not interfere with each other, but the molecule remains small, water-soluble and able to travel across membranes,” Gasser said. In their experiments, the team added Ru-Pt to both normal and cancer cell lines. Ru-Pt was shown to be more effective at killing cancer cells than the single compounds Ru(II) and Pt(IV). The study’s authors reported laser irradiated samples had significantly higher tumour-killing rates, indicating the specific drug activation was possible. They concluded that Ru-Pt had a 10 times higher efficiency for drug-resistant cell lines than the single reagents, from which the researchers suggested multi-modal drugs may be the key to developing more selective and effective drugs with fewer side effects for treating cancer.

Pre-Filled Syringes Europe

Pre-Filled Syringes Europe

SMi is proud to present the 13th Annual Pre-Filled Syringes Conference in London on 13th and 14th January 2021.

Etico-life-sciences-Pre-Filled-Syringes-EuropeThe pre-filled syringes industry is growing at an exponential rate. With increasing demand for self-administration, a rise in biologics, large-volume delivery and the delayed EU MDR at the forefront of the field, SMi’s 13th annual event will bring you the key insights you need to grow and enhance your pre-filled syringes portfolio and discover what the future holds for the PFS and combination products industry.

Topics of discussion will include the latest updates on the EU MDR and Article 117, advances in novel drug products and biologics, parenteral packaging for pre-filled syringes, innovations in device design and platforms for combination products, lifecycle management and much more…

The two-day agenda offers you peer-to-peer networking with Global Product Managers, Senior PFS Engineers, Device Testing Managers, Heads of Late-Stage PFS Development and many more.

As Europe’s first Pre-Filled Syringes Conference of 2021, this event is not to be missed. We look forward to welcoming you to the conference in January.