Advance planning is essential to ensure a reliable supply for parenteral drug packaging

A Clear Strategy for Primary Packaging

Consistency, robustness, and API-excipient understanding are essential for successful drug release.

On-Time Drug Delivery

Despite challenges caused by COVID-19, M&A activity in life sciences is recovering well.

Analyzing European M&A Activity Post-COVID

Intelligent analytical tools detect impurities in small-molecule drug ingredients.

The Search for Unknown Impurities

Okra gum serves as a polymer for oral drug formulations.

Novel Drug Delivery Using Okra Gum

Microbial experts should employ proactive practices on the manufacturing floor.

Optimizing Microbial Control

UK Approves Moderna for Adolescents; Updates on Solidarity Plus Trial

Pfizer Vaccine Approval Key to Boosting Vaccination Rates

Technology Forum: The Next Steps for Pharma Manufacturing Efficiency and Effectiveness

PharmaLex announced a joint venture with OSTHUS Services, a consulting and system integrations firm, on Sept. 14th, 2021. The goal of this venture is to expand PharmaLex’s information technology (IT) consulting and system expertise in the life sciences industry.

OSTHUS will provide PharmaLex with data and information technology strategy, data governance, and advanced analytics and laboratory informatics. Ultimately, they hope to transform data into digital assets that can drive informed decision-making, expand knowledge, reduce costs, and accelerate time to market.

“OSTHUS creates value through an integrated business, data, and IT strategy. The alliance with PharmaLex allows us to expand our business to provide vendor-agnostic consulting and solutions for our growing Life Sciences customer base,” said Andreas Mohr, a member of OSTHUS’ founding team, in a PharmaLex press release. “We look forward to leveraging PharmaLex’s reputation as a leading provider in the industry to remove innovation barriers and to promote a data and technology-centric business culture.”

Andreas Mohr, a member of the company’s founding team, will continue to lead and manage OSTHUS Services. Torsten Osthus will support PharmaLex and OSTHUS in an advisory role.

“The collaboration with OSTHUS will serve to strengthen our Technology Enabled Smart Services, the ‘Global Statistics and Data Science’ unit, as well as our computerized system validation and data governance services, while benefiting our information technology group as we build our own data warehouse,” said PharmaLex CEO Thomas Dobmeyer in the press release. “Together with OSTHUS we now have the manpower and expertise to deliver the growing client demand of building customized information technology solutions. Our technology-enabled solutions deliver a step change in the efficiency, speed, quality, and responsiveness of business processes and support faster and more informed decision making.”

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The joint venture with OSTHUS will expand PharmaLex’s IT consulting and system integration expertise.

PharmaLex Completes Joint Venture With OSTHUS Services

CPC (Colder Products Company), an operating company within Dover, announced a new series of ultra-compact sterile connectors, the MicroCNX Series Connectors, on Sept. 2, 2021. According to a company press release, this product is the first alternative to tube welding for small-volume, closed aseptic processes.

MicroCNX connectors are specifically designed for small-volume processes involving 1/16 in. (1.6 mm), 3/32 in. (2.4mm), and 1/8 in. (3.2mm) small-bore tubing. Some of the more common uses for these tubings are sampling, seed train expansion, and early cell-culture processes that involve shaker flasks and rocker tables. The connectors can be incorporated into pre-made tubing assemblies. 

To use the aseptic connector, users must pinch to remove the protective cover, click together the connector halves, and pull out the protective membranes to allow flow to begin. This process is intended to be a simpler solution to traditional tube welding, which requires maneuvering the tube welder into position, equipment maintenance, and precise technique.

“MicroCNX connectors are a critically important option for a range of bioprocessing, cell therapy and gene therapy workflows,” said Troy Ostreng, senior product manager for CPC’s biopharmaceutical business, in the press release. “Until now, cumbersome tube welding has been the only way to make sterile closed connections of very small-bore tubing. The MicroCNX connector represents a huge innovation for the industry.”

CPC’s MicroCNX Series Connectors provide an alternative to tube welding at small tubing sizes.

New Sterile Connectors for Small-Bore Tubing Offer an Alternative to Welding

AzurRx BioPharma, a company specializing in developing targeted, non-systemic therapies for gastrointestinal diseases (GI), announced that it has entered a definitive agreement to acquire First Wave Bio, a clinical-stage biotechnology company, on Sept. 13, 2021 in a press release. AzuRx acquired First Wave Bio for approximately $229 million in stocks and cash.

First Wave Bio specializes in developing novel, gut-targeted, small-molecule therapies for auto-immune inflammatory bowel diseases (IBD) and other serious conditions. AzurRx will wholly own all rights to First Wave Bio’s proprietary formulations of niclosamide, a small molecule drug featuring anti-viral and anti-inflammatory properties designed to address various GI conditions. They will also gain rights to patented methods of use and delivery mechanisms of these formulations as treatments for various auto-immune, inflammatory, and viral conditions.

Following this acquisition, AzurRx BioPharma will operate under the name First Wave BioPharma. James Sapirstein, AzurRx’s chairman, president, and CEO, will continue to lead the company. Their new stock ticker symbol, FWBI, is expected to be effective by Sept. 23, 2021.

“The acquisition of First Wave Bio and the creation of First Wave BioPharma is a transformative event that significantly expands our GI development pipeline and positions our company for new growth opportunities in the inflammatory bowel disease [IBD] therapeutic space,” said Sapirstein in a company press release. “We believe that our proprietary formulations of niclosamide, with their novel anti-inflammatory mechanism of action, non-systemic absorption, and safety benefits, will enable us to address significant unmet clinical needs for IBD patients, especially in the mild-to-moderate disease categories.”

“This is an exciting day,” said Gary D. Glick, CEO and founder of First Wave Bio, in the press release. “We believe the acquisition of First Wave Bio by AzurRx will unlock the value of our proprietary niclosamide formulations targeting IBD. We are confident that the AzurRx team will successfully advance these programs along their respective clinical and regulatory pathways.”

AzurRx’s acquisition of First Wave Bio grants them access to their proprietary niclosamide formulations.

AzurRx BioPharma Acquires First Wave Bio for $229 Million

FDA, in partnership with the European Medicines Agency (EMA), announced a pilot program to provide parallel scientific advice (PSA) to applicants of abbreviated new drug applicants on Sept. 15, 2021, in an EMA press release. This advice is geared toward applicants applying for FDA’s complex generic drug products or marketing and EMA’s marketing authorization applications of hybrid products.

The pilot program is an expansion of the existing PSA for new drugs and biological products offered by FDA and EMA. The goal of the new program is to allow FDA/EMA assessors to concurrently express their views on scientific issues with applicants during the development phase for generic drugs and hybrid products, providing applicants with the ability to harmonize proposals in advance of their application.

To request a meeting with the agencies, applicants should send a “Request for PSA” letter to the EMA at emainternational@ema.europa.eu and FDA at preANDAHelp@fda.hhs.gov. These requests will be received until the agencies determine that a sufficient number of meetings needed to assess the program have been scheduled.

Further questions about the program can be directed to preANDAHelp@fda.hhs.gov.

FDA and EMA will provide scientific advice to applicants concerning complex generic and hybrid products.

FDA and EMA Launch Program to Advise Prospective MAAs and ANDAs Applicants

Repligen Corporation, a life sciences company focused on bioprocessing technology, and Navigo Proteins GmbH, a protein engineering company, announced on Sept. 9, 2021, the completion of the development and validation of a novel protein A ligand, the NGL-Impact A Hi pH, that addresses antibody aggregation in low pH elution buffers and challenges associated with Fc-fusion proteins.

Protein A affinity ligands enable the affinity purification of monoclonal antibody-based biologic drugs in Protein A chromatography media. However, according to a company press release, this is the first ligand to address antibody aggregation in low pH elution buffers. It was specifically developed to address pH-sensitive antibodies and Fc-fusion proteins, but it can also be considered for “platform” use due to its broad pH operating range and high performance across all antibodies.

“[This new ligand] addresses one of the major pain points in antibody drug purification, which is the formation of aggregates during Protein A elution,” said Ralf Kuriyel, senior vice-president of R&D at Repligen, in the company press release. “Our new NGL-Impact A Hi pH ligand has demonstrated in customer evaluations two-fold lower levels of aggregate formation while maintaining high dynamic binding capacity and excellent caustic stability. We have completed all scale-up and validation work and now look forward to this ligand being commercialized on a new resin later this year, through our partnership with Purolite.”

“The introduction of a high pH, high performing ligand into the market represents a potential real cost and time savings for developers of pH-sensitive antibodies and Fc-fusion proteins,” said Henning Afflerbach, CEO of Navigo Proteins, in the press release. “We believe the performance enabled by this ligand will prove very attractive in the market, for purification of all antibodies and Fc-containing proteins.”

Repligen and Navigo’s novel ligand could be the first to address antibody aggregation in low pH elution buffers.

Repligen and Navigo GmbH Launch Industry-First Protein A Ligand for Purification of pH-Sensitive Antibodies

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.”

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.

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