Pharmaceutical Technology Editors

AGC Biologics announced expansion plans on Sept. 13, 2021, for its Heidelberg, Germany facility to raise manufacturing capacities for plasmid DNA (pDNA) and messenger RNA (mRNA) projects.

The expansion will boost the company’s current 100-L and 1000-L manufacturing capacities with the addition of a new good manufacturing practice (GMP) manufacturing line. Other additions include a new GMP cleanroom for mRNA development and manufacturing, a new process development lab for microbial protein and cell and gene therapy (CGT) projects, and additional warehouse capacity. The expansions will be fully operational in 2023.

This current expansion is the latest in a series of investments AGC Biologics has made this year. In August 2021, the company 

broke ground on a new multipurpose facility in Copenhagen, Denmark

, to grow its global capacity and acquired a 

CGT commercial manufacturing facility in Longmont, Colo.

 Earlier this year, the company expanded its CGT facility in Milan, Italy, and added additional capacity and viral vector suspension capabilities.

“This investment helps strengthen our existing pDNA capabilities and supports our entry into the mRNA space,” said AGC Biologics CEO Patricio Massera in a company press release. “With the global pDNA and mRNA markets experiencing record growth, we are focused on ensuring our facilities worldwide offer innovative services that meet the needs of therapeutics developers.”

“These new capacities will help strengthen our Heidelberg facility,” said Dieter Kramerm, AGC Biologics Heidelberg site head, in the press release. “We are looking forward to this location having a greater impact on the services AGC Biologics offers to our industry.”

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AGC Biologics is expanding manufacturing capacity at its Heidelberg, Germany, facility for plasmid DNA and messenger RNA.

AGC Bio Boosts Manufacturing Capacity for pDNA and mRNA at Heidelberg Facility

HUTCHMED, a commercial-stage biopharmaceutical company, announced on Sept. 13, 2021, that China’s National Medical Products Administration granted breakthrough therapy designation (BTD) for amdizalisib (HMPL-689) for the treatment of relapsed or refractory follicular lymphoma (FL), a subtype of non-Hodgkin's lymphoma (NHL). According to a company press release, this condition affects roughly 17% of patients with NHL.

Amdizalisib is an inhibitor for PI3Kδ (phosphoinositide 3-kinase delta), a lipid kinase that controls the activation of several important signaling proteins. When an antigen binds to B-cell receptors, PI3Kδ can be activated through the Lyn and Syk signaling cascade. According to the press release, the abnormal activation of B-cell receptor signaling is closely related to the development of B-cell type hematological cancers, which represent approximately 85% of all NHL cases. Therefore, HUTCHMED considers PI3Kδ a promising target for drugs that aim to treat certain hematologic cancers.

HUTCHMED has an ongoing Phase II clinical study in China concerning the use of amdizalisib featuring 100 patients with relapsed or refractory FL and approximately 80 patients with marginal zone lymphoma. A phase I/Ib study in the United States and Europe is also ongoing.

“The granting of BTD to amdizalisib by the NMPA underscores the promising clinical value of this highly selective and potent PI3Kδ inhibitor,” said Christian Hogg, CEO of HUTCHMED, in the press release. “There is a clear need for new therapies in this treatment setting, particularly with regard to specific toxicities and suboptimal efficacy with existing treatments across different lymphoma subtypes.”

HUTCHMED’s amdizalisib (HMPL-689) received breakthrough therapy designation for the treatment of a subtype of non-Hodgkin’s lymphoma.

HUTCHMED Receives Breakthrough Therapy Designation from China’s NMPA

Marion Gruber and Phillip Krause, two FDA officials who 

 they would be leaving the agency after clashing with Biden over the need for booster vaccines, were among 18 authors of a paper published in 

 (1) on Sept. 13, 2021 disputing the need for booster vaccines for most people.

The current administration has firmly backed booster vaccines, with the Department of Human Health and Services 

 that they believed booster vaccines would be needed. However, others, such as World Health Organization Director-General Tedros Adhanom Ghebreyesus, 

 against those calling for immediate booster shots, stating that it is more pressing to increase vaccine coverage in underserved countries.

The contention of Gruber, Krause, and the other authors of the paper, “Considerations in Boosting COVID-19 Vaccine Immune Responses”, centers on the assertion that there is no substantiated scientific backing for boosters for most people. According to the paper, initial findings from randomized trials have shown strong efficacy of the vaccines.

The authors of the paper showed concern that booster vaccines might result in unintended, adverse effects in recipients, which could also cause increased vaccine mistrust in the general population. Similarly, they worry that public opinion on the efficacy of the vaccine will be undermined by calls for a booster less than a year after release.

“Although the idea of further reducing the number of COVID-19 cases by enhancing immunity in vaccinated people is appealing, any decision to do so should be evidence-based and consider the benefits and risks for individuals and society,” stated Krause et al. in the paper.

“If boosters (whether expressing original or variant antigens) are ultimately to be used,” continued Krause et al. “There will be a need to identify specific circumstances in which the direct and indirect benefits of doing so are, on balance, clearly beneficial. Additional research could help to define such circumstances.”

. online, DOI:10.1016/S0140-6736(21)02046-8(Sept. 13, 2021).

Both Marion Gruber and Phillip Krause, FDA officials, co-authored a document disputing the need for COVID-19 boosters for most people.

Former FDA Scientists Dispute Need for Booster Vaccines

ABITEC, a subsidiary of ABF Ingredients, announced a memorandum of understanding (MoU) agreement with Luca AICell, a bio-platform technology company, on Sept. 10, 2021.This MoU supports an agreement to pursue foundational research that aims to advance the use of ultra-high purity lipidic chemistries across various disciplines.

Luca AICell developed a proprietary artificial cell membrane technology, the LUCA Lipid Bilayer-LLBTM, that uses artificial intelligence to optimize their nano-assembly technology. Per an ABITEC press release, this allows them to work with various types of unique functional lipids and apply optimal formulation ratios to create artificial membranes.

“Lipid nanoparticle technology is a drug delivery system that injects various vaccines and active drugs into our body to ensure that the substance is maintained in different physiological environments and protected to reach the target point,” said Nam-Joon Choo, the developer of the artificial membrane technology at Luca AICEll, in the press release. “Through this joint research collaboration and business partnership (commercialization) with ABITEC, it is not only possible to produce mRNA [messenger RNA] vaccines, but also possible to establish a standard platform technology that composes a delivery system suitable for the characteristics and administration purpose of various infectious disease vaccines.”

“It is through visionary collaborations with [organizations] such as Luca AICell that has provided ABITEC the opportunity to expand our focus towards basic science, as opposed to historic short-term commercial drivers.” said Donal Kelemen, global business director for ABITEC, in the press release.“We believe this directional approach towards innovation is paramount to the development of impactful lipid products and their associated applications to further understand and address the scientific and biological challenges facing the market sectors that we serve today and tomorrow.”

The memorandum of understanding between ABITEC and Luca AICell will work to advance ultra-high purity lipidic chemistries.

ABITEC Enters into Memorandum of Understanding with Luca AICell

Twist Bioscience, a company that provides synthetic DNA libraries, announced a research collaboration with Boehringer Ingelheim on Sept. 9, 2021. The collaboration will allow Boehringer Ingelheim to use Twist’s antibody libraries to discover therapeutic antibodies for various targets.

Twist will use its ``Library of Libraries,” a panel of synthetic antibody phage display libraries derived entirely from sequences that exist in the human body, to identify potential therapeutic antibody candidates. The two companies will then work together to validate and optimize any new antibody candidates.

Under the agreement, Twist will receive an upfront payment for each program entry and has the potential to earn up to a total of $710 million in success-based milestone payments. Boehringer Ingelheim retains exclusive worldwide rights to develop and commercialize any resulting therapeutic antibodies.

“Boehringer Ingelheim believes [that] Twist’s ability to generate potent, diverse therapeutic antibodies by mining its comprehensive libraries, combined with our extensive capabilities and experience in drug discovery and development, will enable us to deliver breakthrough opportunities to patients,” said Clive R. Wood, senior corporate vice-president and global head of discovery research at Boehringer Ingelheim, in a company press release. “We look forward to working with Twist on molecular targets in a broad range of disease areas.”

“This discovery collaboration with Boehringer Ingelheim covering numerous targets truly illustrates the power of our antibody libraries,” said Emily M. Leproust, CEO and co-founder of Twist, in the press release. “We have the ability to generate precise antibodies to a diverse range of targets, which together with Boehringer Ingelheim’s strength in drug development capabilities, could mean multiple new more personalized treatments in the future for patients.”

Boehringer Ingelheim and Twist Bioscience will use Twist’s antibody libraries to discover therapeutic antibody candidates.

Boehringer Ingelheim and Twist Bioscience Team Up for Therapeutic Antibody Discovery

Janssen Pharmaceutical Companies, a subsidiary of Johnson & Johnson, announced that FDA approved their long-acting atypical antipsychotic Invega Hayfera (six-month paliperidone palmitate) for treatment of schizophrenia in adults on Sept. 1, 2021. Paliperidone palmitate is the first twice-yearly injectable for the treatment of schizophrenia in adults approved by FDA, according to a company press release.

The FDA approval follows a 12-month, randomized, double-blind, non-inferiority Phase III study that enrolled 702 adults (ages 18–70) living with schizophrenia from 20 countries. According to the press release, results showed non-inferiority of paliperidone palmitate compared to Invega Trinza (paliperidone), the company’s three-month injectable antipsychotic, on the primary endpoint of time to first relapse at the end of the 12-month period.

The results found that 92.5% of patients treated with paliperidone palmitate and 95% of those treated with paliperidone did not relapse within 12 months. Relapse was defined as psychiatric hospitalization, increase in Positive and Negative Syndrome Scale (PANSS) total score, increase in individual PANSS item scores, self-injury, violent behavior, or suicidal/homicidal ideation.

“For too long, we’ve accepted relapse as a normal part of living with schizophrenia, while research continues to demonstrate that stronger medication adherence means better patient outcomes,” said Gustavo Alva, medical director at ATP Clinical Research and six-month paliperidone palmitate clinical trial investigator, in the press release. “The Phase [III] trial results provide compelling evidence that [six]-month paliperidone palmitate offers longer-term symptom control with the fewest doses per year, which may support greater patient adherence.”

“Long-acting injectable treatments offer a number of advantages compared to oral medication for schizophrenia, including relief from needing to remember to take medication daily, lower discontinuation rates, and sustained treatment over longer periods,” said Bill Martin, global therapeutic area head, Neuroscience, Janssen Research & Development, in the press release. “Today’s approval enables us to rethink how we manage this chronic disease by offering patients and caregivers the potential for a life less defined by schizophrenia medication.”

Janssen’s Invega Hayfera is the first six-month injectable schizophrenia treatment approved by FDA.