Pharmaceutical Technology Editors

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

Pharmaceutical development, manufacturing, and quality efforts are often advanced by the work of industry associations and members through conferences, training sessions, publications, and working groups. These efforts continued during the past 18 months, despite restrictions posed by the COVID-19 pandemic. The American Association of Pharmaceutical Scientists (AAPS) and the International Pharmaceutical Excipients Council of the Americas (IPEC-Americas) shared recent activities and industry contributions with 

Pharmaceutical Technology’s September 2021 Regulatory Sourcebook eBook

Industry Organizations Assist Pharma During the Pandemic and Beyond

Pharmaceutical Technology’s Regulatory Sourcebook eBook

When referring to this article, please cite it as PharmTech Editors, “Industry Organizations Assist Pharma During the Pandemic and Beyond,” 

Pharmaceutical Technology’s Regulatory Sourcebook

Pharmaceutical Technology checked in with AAPS and IPEC-Americas to get an update on how the organizations are navigating the pandemic and planning for the future. 

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.