Christopher Cole

Simona Guidi, Associate Director, Cell and Gene Therapies at ProPharma discusses human contamination considerations during drug manufacturing

Operators Are the Main Source of Contamination in Pharmaceutical Manufacturing


In this short clip from the June episode of our 

 video series, Simona Guidi, Associate Director, Cell and Gene Therapies at ProPharma, explains the importance of considering humans as a top source of contamination in pharmaceutical manufacturing.

Check out the full episode with Guidi on 

 in which she answers questions about options for controlling adventitious contamination for cell processing requiring extensive manipulation and how to protect the product and operating when moving to a closed processing system for cell therapy production.

Videos

Young man having asthma attack or choking suffering from respiration problems | Image Credit: © Feodora - stock.adobe.com

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved EURneffy 2 mg, a needle-free adrenaline nasal spray designed to treat anaphylaxis in adults and children weighing 30 kilograms (66 pounds) or more in the United Kingdom (1). It’s the first product of its kind authorized in the country, and its launch is anticipated in the latter half of 2025, following final market access negotiations.

This milestone approval introduces a fundamentally different route of administration for emergency adrenaline, delivered intranasally rather than via auto-injector (1). The shift comes as manufacturers and developers across the pharmaceutical industry continue to explore more intuitive, less invasive drug delivery formats that can meet real-world demands, particularly in high-stakes use cases like allergic reactions (2–6).

Redesigning emergency treatment with device innovation

·MHRA approval of EURneffy introduces the first nasal adrenaline spray for anaphylaxis, offering a needle-free alternative to traditional auto-injectors.

·EURneffy features 30-month shelf life and high temperature stability, addressing long-standing cold chain and storage challenges in pharma logistics.

·The product’s design reflects growing industry emphasis on human factors engineering to improve real-world usability and adherence in emergency drug delivery.

EURneffy’s design eliminates the needle entirely, a departure from decades of reliance on injection-based delivery (1). For patients and caregivers, this simplifies use during the chaotic moments of anaphylaxis, when speed and confidence are critical. It also opens new considerations for drug-device development: designing for intuitive usability while maintaining pharmacologic equivalence to injectable formats.

Henriette Mersebach, MD, executive vice president of research and development at ALK, emphasized this point in a statement, stating, “The approval of EURneffy 2 mg in the UK introduces an alternative and novel adrenaline treatment option for adult and adolescent patients with life-threatening allergies. EURneffy could improve the lives of people with severe allergic reactions and may facilitate that patients and caregivers continually carry adrenaline wherever they go" (1).

The product is also formulated to be stable for up to 30 months and at a wider range of temperatures than existing auto-injectors (1). This extended stability means fewer constraints in transportation and storage, allowing for broader reach and potentially reducing waste from expired inventory. It also reflects a growing focus within pharma on formulations that ease cold-chain requirements without compromising efficacy (7–11).

Clinical program supports pharmacological performance

MHRA approval followed a review of data from more than 700 participants enrolled in the EURneffy development program (1). Across a range of dosing scenarios, the pharmacokinetic and pharmacodynamic profiles of the nasal spray were consistent with those of traditional auto-injectors. No serious adverse events were reported during clinical studies.

Anaphylaxis affects approximately eight in every 100,000 people annually in Europe, and about one in 300 will experience it at some point in their lives (1). Despite this prevalence, hesitancy and misuse around auto-injectors remain common. EURneffy highlights how thoughtful design and delivery innovation can help improve adherence by minimizing user burden.

The nasal spray was originally developed by ARS Pharmaceuticals, based in the United States (1). In 2024, ALK entered into a licensing agreement with ARS to commercialize the product outside the United States, Australia, New Zealand, Japan, and China. The partnership expanded in 2025 to include co-promotion in the US market.

Although the approval marks a significant product development and regulatory milestone, the company noted it will not impact its financial guidance for 2025 (1).

EURneffy Approved as the First Needle-free Anaphylaxis Treatment of Adults and Children in the UK

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Articles

Newly approved needle-free adrenaline spray offers longer shelf life, better stability, and easier use, signaling a shift in emergency drug delivery design.

UK Anaphylaxis Nasal Spray Approval Helps Reshape Emergency Allergy Treatment

3d render, number six glowing in the dark, pink blue neon light | Image Credit: © NeoLeo - stock.adobe.com

Pharmaceutical compounding, particularly in 503A and 503B environments, involves complex formulation and regulatory challenges far beyond academic theory. This summary of 

 on this topic—written by industry professionals Paul Pluta RPh, PhD, Alan Mancini RPh, Nishant Thakar, RPh, PharmD, and Varanya Chaiyaperm, RPh, PharmD—distills the essential technical and operational takeaways from a comprehensive, six-stage model of pharmaceutical compounding. Ideal for professionals in drug development, manufacturing, QA/QC, and regulatory compliance, this summary emphasizes real-world application, risk mitigation, and alignment with quality frameworks like Quality by Design, Good Manufacturing Practices (GMP), and Quality Risk Management (QRM).

Stage 1: design the compounding blueprint

Establish a complete plan including ingredients, packaging, calculations, labeling, and patient-specific factors.

Integrate regulatory standards (US Pharmacopeia, FDA bulk lists, GMP) and proactively identify risks using QRM tools.

Ensure aseptic setup, verified materials, and technician preparedness—especially critical for sterile and high-risk compounds.

Require dedicated or disposable equipment for hazardous or cross-contaminating drugs (e.g., antineoplastics, allergens).

Stage 3: dosage form completion & quality evaluation

Conduct rigorous physical and analytical testing; 503B batches must meet GMP-level standards.

Finalize documentation with full traceability and ensure preparations are quarantined until verified.

Stage 4: packaging & patient-ready delivery

Assemble patient/client information equivalent to commercial products. Ensure all packaging, labeling, and delivery logistics meet regulatory and clinical standards.

Implement safeguards for temperature control and light protection during distribution.

Stage 5: independent verification before release

Engage an independent observer to verify formulation integrity, test results, documentation, and labeling accuracy.

Use checklists to prevent critical errors and maintain consistent approval protocols.

Stage 6: dispensing, distribution & final safety checks

Dispense only after final pharmacist approval, ensuring two-point patient ID verification.

Monitor for common hazards like name mix-ups, transcription errors, and shipping delays.

Management takeaways: quality starts at the top

Leadership must prioritize hiring, SOP adherence, continuous training, and fostering a quality-driven culture.

Management bears ultimate responsibility for SOP execution, staff performance, and patient safety outcomes.

The six-stage compounding model offers a structured, risk-aware approach to compounded drug development. For pharmaceutical manufacturing professionals, it ensures regulatory alignment, enhances process reproducibility, and reinforces a culture of quality and accountability across the compounding lifecycle.



A structured, risk-based framework for pharmaceutical compounding that enhances quality, regulatory compliance, and process consistency.

The 6-Stage Compounding Framework Every Pharmaceutical Manufacturing Professional Should Know

Kyiv, Ukraine - December 22, 2020: Backlit single shot image of GlaxoSmithKline logo on tv screen with a hand holding an Covid-19 vaccine concept | Image Credit: © Олександр Луценко - stock.adobe.com

FDA has approved a prefilled syringe version of GSK’s Shingrix, a recombinant zoster vaccine used to prevent shingles, eliminating the need for reconstitution of separate vials prior to administration (1). The newly approved format aims to ease preparation for healthcare professionals, enhancing efficiency and reducing the risk for handling errors during vaccination.

The previous formulation of the shingles vaccine required clinicians to combine a lyophilized antigen with a liquid adjuvant prior to administration (1). FDA’s approval of the new single-syringe version follows data confirming its technical comparability with the original two-vial presentation.

·FDA approval of the prefilled syringe version of the recombinant zoster vaccine supports manufacturing shifts toward ready-to-use, single-dose formats.

·Technical comparability data enabled regulatory clearance without reformulation, highlighting the value of platform consistency in vaccine development.

·Prefilled syringe design may enhance uptake by reducing administration errors and simplifying logistics across healthcare and immunization programs.

Brigid Groves, vice president of professional affairs at the American Pharmacists Association, emphasized the practical benefits of this update (1): “The prefilled syringe presentation of GSK’s shingles vaccine is good news, providing a convenient method of administration. The FDA approval is a positive step toward driving prevention of this painful disease, and as a practicing pharmacist I welcome the availability of this new presentation.”

Expanded access and continued eligibility guidelines

As with the original version, the prefilled syringe formulation is licensed in the United States for immunization of adults aged 50 and older, as well as individuals aged 18 and older who are or will be immunocompromised due to disease or medical treatment (1). Current guidance from the Centers for Disease Control and Prevention recommends a two-dose series of the vaccine for these groups to help prevent shingles and its complications.

Tony Wood, chief scientific officer at GSK, commented on the public health rationale for the updated presentation, stating “at GSK, we are committed to advancing scientific innovation and delivering practical solutions that address the needs of the healthcare community. This new presentation of Shingrix was developed to streamline the vaccination process, supporting healthcare professionals to provide protection against shingles, a disease that one in three US adults will develop in their lifetime” (1).

In parallel to the US approval, the prefilled syringe presentation is under review by the European Medicines Agency, with the application accepted for evaluation in January 2025 (1). Regulatory submissions are also being considered for additional international markets.

These developments reflect a broader industry focus on increasing adult immunization rates through simplified vaccine formats.

Shingles, also known as herpes zoster, is a painful skin rash caused by reactivation of the varicella-zoster virus (VZV)—the same virus responsible for chickenpox (2). While not all individuals with latent VZV will develop shingles, nearly 99% of US adults over 50 harbor the virus, and about one million cases are diagnosed annually in the US (3).

With age, immune function diminishes, increasing the likelihood that the virus will reactivate (4). This makes older adults more susceptible to shingles and its associated complications, including postherpetic neuralgia, a condition characterized by long-lasting nerve pain.

The recombinant zoster vaccine is a non-live, subunit formulation that combines glycoprotein E with the proprietary AS01B adjuvant system (1). It is designed to trigger a strong immune response even in older adults, whose immune systems may respond less robustly to vaccination. The vaccine is not intended to prevent chickenpox or primary varicella infection.

The newly approved Shingrix format comes just days after GSK announced that FDA had accepted GSK’s application to extend the indication for the company’s respiratory syncytial virus (RSV) vaccine, adjuvanted (Arexvy) to adults aged 18–49 who are at increased risk (5). The vaccine is approved in the US to prevent lower respiratory tract disease (LRTD) caused by RSV in adults older than 60 years. It is also approved to treat people aged 50–59 who have increased risk for LRTD caused by RSV.

US FDA Approves GSK’s Shingrix in a Prefilled Syringe Presentation. Press Release

Harpaz, R.; Ortega-Sanchez, I.; Seward, J.; et al. 

Prevention of Herpes Zoster: Recommendations of the Advisory Committee on Immunization Practices (ACIP)

Varicella Zoster Virus Infection: Clinical Features, Molecular Pathogenesis of Disease, and Latency

GSK Seeks Expanded Use Approval from FDA for RSV Vaccine Arexvy

FDA Approves Shingrix Prefilled Syringe to Simplify Vaccine Administration

Tore Bergsteiner summarizes the promise of AI

AI Boosts Early Disease Detection and Diagnostic Accuracy

 back in March 2025, Tore Bergsteiner, managing partner at MAIN5, a European consulting firm specializing in digitally enabled change for life sciences R&D organizations, discusses how AI is increasingly enhancing diagnostics and pathology by enabling early disease detection through advanced image analysis, improving treatment outcomes and patient safety. He also notes how AI helps address global shortages of pathologists by boosting diagnostic efficiency and accuracy. Both points still hold true 4 months later.

Check out our full interview with Tore 

Tobin bridge, Zakim bridge and Boston skyline panorama at sunset | Image Credit: © mandritoiu - stock.adobe.com

The 15th annual Partnership Opportunities in Drug Delivery (PODD) conference, set for October 27–28, 2025, at the Westin Copley Place in Boston, will spotlight the latest developments in drug delivery technology with a program of expert panels, presentations, and industry-driven sessions (1).

Organized by the Conference Forum, the event brings together pharmaceutical developers, biotech innovators, and drug delivery specialists to examine advances in the formulation, design, and commercial deployment of therapeutics across a range of modalities (1).

Focus on strategic partnering in drug delivery

·Drug delivery partnerships are evolving, with top pharma leaders outlining strategic evaluation frameworks for external technologies and collaboration models.

·Pharma innovation leaders are refining internal scouting, sharing insights into sourcing enabling technologies that accelerate drug development pipelines.

·Health economics of drug delivery are under scrutiny, as payers assess how delivery systems influence value, pricing pressure, and access for emerging therapies.

Partnering to Advance Drug Delivery Innovation

, director of strategic innovation for rare diseases at Chiesi USA (1). The session will explore critical considerations for evaluating external drug delivery platforms, with panelists offering perspectives from both early-stage and mature development environments.

, research & development advisor for Genetic Medicine at Eli Lilly and Company

, head of advanced drug delivery at AstraZeneca

, head of global biopharmaceutics and senior research fellow at Pfizer

, director of portfolio strategy & integration at Bristol-Myers Squibb.

The discussion will focus on partnership pathways, strategic fit assessments, and the evolving landscape of delivery technology collaborations (1).

Pharmaceutical leaders share internal approaches to innovation

Representatives from Novartis and AbbVie will offer insights into their respective organizations' approaches to sourcing and integrating drug delivery and enabling technologies (1). 

, global head of innovation at Novartis, and 

, senior director of landscaping & platform definition at AbbVie, will present as part of the conference’s 

These presentations are expected to provide transparency into current technology scouting efforts and collaborative models used to accelerate therapeutic development (1).

Economic considerations in drug delivery adoption

 will explore the intersection of innovation and reimbursement, with a focus on the pharmacoeconomics of delivery-enabled therapeutics (1). The panel will assess how delivery systems influence value perception, pricing pressures, and market access—especially in the context of drug classes such as incretins and nucleic acid-based therapies.

Dr. Gail Ryan, PharmD, formerly of Point32Health.

Technology tracks cover injectable, non-injectable, and genetic delivery

The 2025 agenda includes a comprehensive lineup of drug delivery technology presentations categorized into several themes (1):

injectable formulations and delivery platforms

self-injection devices, wearables, and connected delivery tools

oral, nasal, pulmonary, and alternative non-injectable systems

cell and gene therapy delivery approaches

innovations in excipients and combination product platforms

primary packaging solutions including syringes and containers.

Emerging topics in advanced therapeutic delivery

Sessions will also explore specialized approaches to delivery challenges in advanced modalities (1). Topics include:

brain delivery via formulation and physical mechanisms

novel vehicles for genetic medicine administration

tissue-specific targeting for nucleic acid therapeutics

manufacturing scale-up strategies for clinical and commercial readiness

sustainability in drug and device development.

Industry participation reflects broad engagement

The conference will feature speakers and presenters from across the global pharmaceutical ecosystem (1). Participating companies include major developers and technology providers working in small molecules, biologics, cell and gene therapies, and RNA-based drugs.

Participating organizations include: Amgen, Astellas Pharma, AstraZeneca, Beam Therapeutics, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Chiesi USA, Eli Lilly and Company, Genentech, Gilead Sciences, GSK, Merck, Moderna, Novartis, Novo Nordisk, Pfizer, Regeneron, Roche, Sanofi, Sun Pharma, Takeda Pharmaceuticals, Teva Pharmaceuticals, UCB, and others.

PODD’s role in the drug delivery ecosystem

"PODD connects industry leaders and innovators who advance the design and development of drug delivery systems and devices to improve patient lives," said Andrew Goldstein, senior conference producer (2).

Designed to support scientific exchange and partnership building, PODD offers attendees a structured environment to explore delivery solutions for a wide range of therapeutic challenges (1). The forum supports deal-making, technology scouting, and collaboration-building across traditional boundaries in the pharmaceutical sector.

The full agenda release comes three weeks after keynotes were announced (3). At the time, Goldstein said, “In presenting a strategic-level program for R&D scientists and business development professionals, the PODD Conference is committed to securing keynotes who demonstrate excellence in science.”

Keynotes will feature prominent voices in pharmaceutical science and patient advocacy (3). 

, MD, PhD, co-founder and chief scientific officer of Regeneron, will join Massachusetts Institute of Technology’s 

, to discuss the current landscape and future potential of drug delivery innovation. 

, chief scientific advisor at Novo Nordisk, will present on the development of liraglutide and semaglutide, emphasizing how drug delivery intersected with the scientific and clinical advancement of these obesity treatments. Patient advocate 

 will share his experience living with sickle cell disease and undergoing treatment with a clustered regularly interspaced short palindromic repeats, or CRISPR, -based therapy, as well as his efforts to improve access to genetic medicines. 

, university distinguished professor at Northeastern University, will present on strategies for endogenous targeted delivery, addressing how biological transport mechanisms can be leveraged to improve drug efficacy and safety.



Partnership Opportunities in Drug Delivery 2025

Leading Drug Delivery Conference PODD Announces its 15th Annual Agenda

PODD Drug Delivery Conference Announces 2025 Keynotes. Press Release

The annual Boston conference will explore strategic partnering, device innovation, and delivery solutions for emerging therapeutics.