Susan Haigney

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The US Pharmacopeia (USP) announced on Oct. 30, 2023 that ATCC and USP have collaborated to create a set of joint products to advance quality control of biological therapies and vaccines. The six products include highly characterized and pure genomic DNA (gDNA) from cell lines. The cell lines can be used to measure residual host cell DNA; gDNA can pose a safety risk if not removed from the product.

These six products allow for the testing of drug substance and process intermediates to determine if residual gDNA has been cleared, using analytical reference materials derived from an authenticated cell line. Derived from host cell lines commonly used in the manufacture of vaccines and biologics, the products support the following platforms:

“Developing cutting-edge medicines in the biologics space requires trusted reference materials and standards to ensure quality, consistency, and safety,” said Amanda Cowley, general counsel and senior vice president Legal, Strategy and People of USP, in a press release. “With increased demands around the globe for new biological medicines on accelerated timelines, it’s essential that there are products and solutions that can be used to address and advance quality assessment and bring confidence to the development process. By focusing on the detection of gDNA, this first set of ATCC and USP products is significant for the future of biological development as it addresses a common concern when it comes to quality and mitigating risk.”

“This initial set of gDNA products are the first of many that will help ensure the quality and safety of biologic therapies which is of utmost importance not only to biopharmaceutical developers and manufacturers, but ultimately patients,” said Ruth Cheng, PhD, ATCC senior vice president and general manager, Research & Industrial Solutions, in the press release. “They trust us to provide them with reference materials and standards that produce reliable, reproducible, and comparable results, so they can deliver the next generation of high-quality and safe treatments to patients.”

ATCC, a global biological materials and standards organization, and USP are planning to release additional product portfolios that provide materials and standards for the development of biological therapies.

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According to USP, the products will advance quality and reduce risk in the development and manufacture of biologics and vaccines.

ATCC and USP Launch Six Products Used to Detect Residual Host Cell Genomic DNA

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TriLink BioTechnologies, a Maravai LifeSciences Company, announced on Nov. 2, 2023 that it has launched the Analytical Sciences Center of Excellence (ASCE). The new ASCE hub expands the company’s suite of analytical testing capabilities and, according to the company, will minimize cost and delays associated with outsourcing testing to multiple laboratories. The ASCE, which is located in Maravai LifeSciences’s Pacific Center Boulevard facility in San Diego, Calif., features a 4000-square-foot lab to support plasmid DNA and messenger RNA (mRNA) manufacturing and will be responsible for developing analytical methodologies such as mRNA fingerprinting and sequencing.

“TriLink's new Analytical Sciences Center of Excellence will be a transformative force in the development of nucleic acid therapies,” said Khaled Yamout, senior director of Analytical Services at TriLink, in a press release. “This new lab will allow us to expand our analytical capabilities to meet the growing demands of the market, including specific method development.”

TriLink has developed and qualified 10 unique methods for mRNA characterization with 40 various constructs. The ASCE’s new instrumentation to improve nuclear magnetic resonance, next-generation sequencing, and lipid nanoparticles characterization builds on the company’s method development for construct-specific assays.

“We continue to witness exciting growth in nucleic acid therapeutics—and rapid expansion calls for rapid innovation,” added Kevin Lynch, TriLink’s vice-presdient and general manager of GMP Operations, in the press release. “The ASCE’s centralized analytical capabilities and development of analytical methodologies for the characterization of nucleic acids will advance the industry as we continue to find ways to meet the needs of developers working on life-saving therapeutics.”

TriLink, in addition to the new hub, has an extensive mRNA capping portfolio, advanced scale-up capabilities, and expertise in mRNA, oligonucleotide, and plasmid production. It has been a leader in nucleic acid and mRNA solutions for more than 25 years and provides chemical and biological experiences, contract and development manufacturing services, and readymade and custom materials.

The new centralized hub will provide advanced testing of nucleic acids, which is expected to simplify mRNA substance testing.

TriLink BioTechnologies Launches Analytical Sciences Center of Excellence

FDA released a draft guidance on Oct. 25, 2023 explaining the agency’s procedures for how it requests and conducts voluntary remote interactive evaluations at drug manufacturing facilities and facilities that operate under FDA’s Bioresearch Monitoring (BIMO) program. According to the guidance document, the agency may decide to perform remote interactive evaluations based on mission needs and travel limitations. These types of evaluations may be conducted for preapproval inspections; prelicense inspections; postapproval inspections; surveillance inspections; follow-up and compliance inspections; and BIMO inspections.

As part of FDA’s oversight, the agency conducts inspections of FDA-regulated products and manufacturing facilities. The agency may choose to conduct Remote Regulatory Assessments (RRA) before or instead of an onsite facility inspection. “For instance, if a program office determines that an inspection is not necessary, feasible, or practical, FDA may instead conduct an RRA. An RRA is an examination of an FDA-regulated establishment and/or its records, conducted entirely remotely, to evaluate compliance with applicable FDA requirements. RRAs may consist of (or include) a request to conduct voluntary remote interactive evaluations,” the guidance states. The guidance describes remote interactive tools used to conduct RRA evaluations and refers to use of a combination of these tools as a remote interactive evaluation.

According to the document, FDA will use risk management tools to determine if a facility will be participating in a remote interactive evaluation. However, the agency will not be accepting requests from companies asking FDA to perform a remote interactive evaluation. “Such decisions depend on many factors and information not always known to applicants or facilities, and it would be unduly burdensome on all parties to establish a request-based program,” FDA states in the guidance document.

Facilities will be notified by electronic correspondence or a phone call if they are chosen for a remote interactive evaluation and request the company to confirm willingness to participate in the evaluation. The agency will then work with the company to plan and coordinate evaluation activities. “Declining FDA’s request to perform a remote interactive evaluation could impede our ability to make a timely regulatory decision (e.g., regarding adequacy of a clinical trial used in support of a pending application or adequacy of a drug manufacturing operation described in the application),” the agency states in the guidance.

The guidance describes the agency’s procedures for performing remote interactive evaluations at drug manufacturing and bioresearch monitoring facilities. 

FDA Provides Guidance on Remote Facility Evaluations

On Oct. 25, 2023, the winners of the 2023 CPHI Pharma Awards were announced at the 

 event. The awards are given out for outstanding achievements and contributions to the pharma industry in 12 categories. This year’s winners include:

CEO of Procos, Enrico Zodio, won CEO of the Year as recognition for the company’s development and growth, which exceeds €200 million and includes capacity to further increase production.

Snapdragon Chemistry (a Cambrex company) topped the API Development & Innovation category for its ultra-high temperature (>300 °C) continuous flow manufacturing process for racemization of sotorsib (LUMAKRASTM) P-dione, which harnessed greener technology that resulted in a 58% reduction of process mass intensity.

Lubrizol Life Science Health took home the prize in the Finished Formulation category for its solubility-enhancing excipient designed for parenteral use. Apisolex is a poly(amino acid)-based excipient that provides formulators with methods to enhance the solubility of hydrophobic BCS Class II and IV APIs, by up to 50,000-fold.

The Manufacturing Excellence category went to Luminary Therapeutics for its manufacturing platform, Gamma Delta 2.0+, that brings allogeneic cell therapies to market for less than 10,000 without sacrificing function.

Gasporox took the honors in the Packaging & Machinery section for its AutoMAP Pharma gas measurement system for high or low concentrations of O2 in modified atmosphere packaging.

Catalent won the Supply Chain Excellence category for its Case Management Services, which provides end-to-end supply chain management for autologous and allogeneic cell and gene therapies.

The Regulatory Compliance category went to Lambda Therapeutic Research for their EDC solution that enhances research and data management. The software suite, including IMPTrack, KnowledgeNET, and Biolyte, enables real-time, accurate data capture through advanced functionalities like barcode scanning and retina-based verification. It also manages and retrieves study-related data to improve compliance with regulatory guidelines.

Medicsen took the Drug Delivery & Device Innovation category for its SMARTPATCH. The wearable patch uses ultrasounds to deliver drugs subcutaneously and combines the main benefits of current patch pumps with the upside of eliminating invasive and painful components.

The Accelerating Innovation category went to React4Life’s MIVO (Multi In Vitro Organ), a patented organ-on-a-chip that can host and culture 3D human biological cells or tissues under fluid dynamic conditions as 

Schneider Electric won the Sustainability category for its Energize program. The program leverages the scale of the global supply chain in a pre-competitive fashion to drive system-level change. 

The new Start-Up Initiative category went to InSyBio for its ability to revolutionize the medical ﬁeld, clinical trials, and food/nutrition industries through its targeted biomarker discovery. The company’s highly accurate predictive analytics enables personalization of tests for drugs, nutraceuticals, and nutrition products.

The ‘Heart of Pharma’ award, also new this year, went to Merck KGaA for its Embracing Carers initiative that recognizes the role of family carers.

“CPHI aims to position itself at the ‘heart of pharma’ by creating an environment where everyone in our industry can come together to exchange ideas and build productive new alliances for the ultimate benefit of patients. I whole-heartedly congratulate all winners of this 20th edition of the CPHI Pharma Awards. Those committed to driving innovation across the key disciplines that shape the success of our industry. I’d also like to thank all those who submitted an entry this year, and the members of our jury who so diligently reviewed them,” commented Tara Dougal, Content Director–Pharma at Informa Markets, in a press release.

The winners of the 2023 CPHI Pharma Awards were announced on October 25 at the CPHI Barcelona event.

Winners of the 2023 CPHI Pharma Awards Announced

The European Medicines Agency (EMA) announced on Oct. 24, 2023 that its Medicines Shortages Steering Group (MSSG) has developed a voluntary solidarity mechanism that allows European Union Members States to support each other during drug shortages. The mechanism was based on a plan set up during the COVID-19 pandemic and can only be used under limited conditions. It is a last resort to be used after Member States have exhausted other possibilities.

EU Member States may request assistance in obtaining medicine stocks from other member states if they face a critical shortage that has been escalated to the MSSG for coordination at European level. The mechanism is part of other shortages actions the MSSG can carry out and is part of the MSSG Toolkit, which includes recommendations for monitoring drug supplies. The mechanism and toolkit are part of actions the European Commission is taking to protect the EU from drug shortages.

The agency’s solidarity mechanism allows Member States to support each other when there is a shortage of a critical medicines.

EMA Creates Mechanism for Support during Drug Shortages

FDA announced on Oct. 19, 2023 that it had issued the final guidance, 

Development and Licensure of Vaccines to Prevent COVID-19

, to help sponsors with the clinical development and licensure of COVID-19 vaccines. The document does not address every consideration for satisfying requirements because some vaccines may need specific data, according to the agency. The final guidance reflects FDA’s current thinking on the issue.

“Given the need to ensure that sponsors are aware of our current recommendations to facilitate timely development of vaccines to prevent COVID-19, this guidance is being implemented without prior public comment because FDA has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), (21 U.S.C. 371(h)(1)(C)), and 21 CFR 10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency’s good guidance practices,” the agency stated in the document.

The final guidance explains key considerations for chemistry, manufacturing, and controls including facilities and inspections; nonclinical data, such as toxicity studies; clinical trials, such as trial populations and trial design; post-licensure safety evaluations; and diagnostic and serological assays. In addition, the guidance discusses other safety considerations that should be addressed including demonstrating effectiveness, surrogate endpoints, and adequate datasets. “If it is no longer possible to demonstrate vaccine effectiveness by way of conducting clinical disease endpoint efficacy studies, the use of a controlled human infection model to obtain evidence to support vaccine efficacy may be considered. However, many issues, including logistical, human subject protection, ethical, and scientific issues, would need to be satisfactorily addressed,” FDA stated in the guidance.

The final guidance document was issued to assist bio/pharma companies in the clinical development and licensure of COVID-19 vaccines. 