Pharmaceutical Technology Is Now PharmTech: A Sharper Name for a Smarter Industry

Navigating FDA Shakeups and Obesity Drug Wars

Behind the Headlines Episode 28

Ask the Expert

Closing the Gap in Modern Process Control and Automation for QC/QA

Drug Digest December 2025

How It Helps Avoid Facility and Equipment Problems

A “Plan, Prevent, Prove” Approach

Young woman after chemotherapy taking pills from nurse in hospital room. Brain cancer concept | Image Credit: ©Pixel-Shot -stock.adobe.com

Patient-centric drug development focuses on the patient’s experience and needs to better ensure adherence and enhance treatment. This approach collects and uses patient and caregiver input to inform both drug development and regulatory decision making (1). In 2025, FDA published a series of guidance documents that allows for the patient’s voice to be incorporated into the development process (2) and for a better patient experience.

Medicines, such as those used to treat cancer or rare diseases, developed and formulated using this tailored approach often require pharmaceutical companies to enlist the services of contract development and manufacturing organizations (CDMOs) to assist sponsor companies in performing formulation services, such as drug delivery innovations, predictive modeling, modified-release formulations, solubility, and bioavailability.

 spoke with Dr. Asma Patel, VP Global Commercial and Scientific Consulting–Drug Product, to find out how the growth in patient-centric drug formulations is impacting the CDMO market and how CDMOs can assist sponsor companies in this important work.

PharmTech: Which 2025 trends in drug formulation impacted outsourcing of formulation services?

 In 2025, advanced modalities such as peptides and RNA therapies increased formulation complexity, driving greater outsourcing to CDMOs with specialized scientific acumen and integrated platform capabilities. At Quotient Sciences, Translational Pharmaceutics enabled rapid, data-driven make-test cycles, accelerating development by more than 12 months and lowering costs. This method allows rigorous optimization of formulation parameters from human pharmacokinetic data. Industry dynamics have shifted, with CDMOs moving beyond mere transactional service providers to become strategic partners, providing adaptive manufacturing solutions, robust scalability, and strong regulatory support while maintaining high quality standards.

How has the shift to patient-centric formulations impacted CDMOs?

Patient-centric methodologies have reshaped CDMO operations, emphasizing pharmaceutical solutions tailored for convenience, adherence, and personalization, especially for pediatric and rare disease populations. [This can be demonstrated by] focusing on advanced formulation approaches like taste masking and flexible clinical dosing, boosting compliance and therapeutic outcomes. The adoption of digital and AI technologies supports predictive modeling and process optimization, reducing development risks and formulation failures. As a result, CDMOs now offer adaptive GMP [good manufacturing practice] manufacturing and integrated clinical testing to meet the complex needs of patient-centric drug development.

In developing patient-centric formulations, where can CDMOs best support sponsor companies?

CDMOs play a pivotal scientific role in the advancement of patient-centric drug formulations, particularly through expertise in enhancing solubility and bioavailability, and in developing innovative drug delivery systems, such as modified-release and targeted formulations. An integrated formulation strategy [can] enable rapid optimization using real-time clinical pharmacokinetic data, which minimizes development risk and shortens proof-of-concept timelines. Beyond initial design, CDMOs manage scale-up and ensure commercial readiness, addressing key patient requirements like reduced pill burden and improved dosing convenience. Their ability to align formulation science with manufacturing processes guarantees that patient-centric therapies remain scalable, regulatory compliant, and clinically effective.

How early do CDMOs get involved in discovery/formulation of a novel orphan or rare-disease drug?

CDMOs are increasingly integrated into the preclinical stages of orphan drug development, frequently commencing support during pre-formulation and discovery. Their scientific expertise is vital for maximizing the efficiency of limited API, expediting development timelines, and navigating intricate regulatory frameworks. Early-stage involvement [can] enable design of patient-ready formulations within significantly reduced timeframes, thereby conserving scarce APIs and facilitating accelerated regulatory pathways. Through the deployment of specialized infrastructure and adaptive manufacturing processes, CDMOs effectively address the unique challenges associated with small, heterogeneous patient cohorts and the bespoke requirements inherent to niche pharmaceutical manufacturing.

How important are CDMOs in the formulation and regulatory approval of orphan drugs?

CDMOs play a pivotal role in the development and commercialization of orphan drugs, leveraging specialized expertise in small-batch manufacturing, advanced packaging solutions, and global regulatory compliance. Their integrated platforms facilitate efficient management of complex CMC [chemistry, manufacturing, and controls] processes, ensuring rigorous quality standards and adherence to multi-jurisdictional regulatory requirements. By streamlining workflows and mitigating risks particularly associated with accelerated approval pathways, CDMOs enable rapid scale-up and supply chain resilience for niche patient populations. This strategic collaboration extends beyond formulation, encompassing risk management, and expedited market access, thereby maximizing therapeutic outcomes for orphan and rare diseases.

What do you anticipate for 2026 and beyond for outsourcing formulation services?

The outsourcing landscape for pharmaceutical formulation services is projected to exhibit robust growth, fueled by increased biotechnology investment, the increasing sophistication of novel therapeutic modalities, and mounting requirements for integrated development platforms. The sector is being revolutionized by the deployment of AI, machine learning, and advanced automation, particularly in the rational design of formulations, which facilitates substantial reductions in development cycles. Strategic alliances, such as the Quotient Sciences-Intrepid Labs collaboration (3), exemplify the utilization of predictive modeling to refine formulation parameters and curtail experimental iterations, thereby enhancing efficiency and scientific rigor in drug development.

1. FDA. CDER Patient-Focused Drug Development. 

https://www.fda.gov/drugs/development-approval-process-drugs/cder-patient-focused-drug-development

2. FDA. FDA Patient-Focused Drug Development Guidance Series for Enhancing the Incorporation of the Patient’s Voice in Medical Product Development and Regulatory Decision Making. 

https://www.fda.gov/drugs/development-approval-process-drugs/fda-patient-focused-drug-development-guidance-series-enhancing-incorporation-patients-voice-medical

3. Quotient Sciences. Quotient Sciences and Intrepid Labs form Strategic Partnership to Accelerate AI-guided Formulation Development. Press Release. Dec. 4, 2025.

Articles

Patient-centric drug development prioritizes patient experiences and needs, enhancing adherence and treatment outcomes. The FDA's 2025 guidance supports incorporating patient input into drug development. This approach, especially for cancer and rare diseases, often involves CDMOs for formulation services. CDMOs have evolved into strategic partners, offering advanced manufacturing solutions and regulatory support. They play a crucial role in enhancing solubility, bioavailability, and drug delivery systems. Early involvement in orphan drug development maximizes efficiency and accelerates regulatory pathways. The future of outsourcing in formulation services is driven by biotechnology investment and advanced technologies.

Contract development and manufacturing organizations offer specialized services to help sponsor companies develop drug products that better serve the unique needs of patients.

The Impact of Patient-Centric Formulations on Service Providers

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Liquid Chromatography Research | Image Credit: ©

Aseptic processing must be conducted in a manner that assures sterility (1). Analytics play an integral role in each step of an aseptic process as they are required to properly characterize the product and assess and understand its safety profile and quality to ensure they align with strict regulatory standards (2). Raw materials and buffers must be tested, utilities (steam/gas, water-for-injection) are routinely monitored, and a wide variety of analyses are performed during formulation/compounding and fill/finish activities, including pre-use post-sterilization integrity testing (PUPSIT), and pre/post-use filter integrity tests, environmental monitoring, and container closure integrity (CCI) testing.

The degree of analytical testing varies from one unit operation to another based on process step criticality, time limitations, scale of production, and product application, according to Rajiv Gangurde, vice-president, technical operations, cell and gene therapy at Parexel. Some testing, notably environmental monitoring, is performed in advance of process initiation as a preventive measure. Quality control (QC) release testing confirms sterility, endotoxin levels, particulates, identity/purity/potency, and CCI.

What analytical methods are widely used during aseptic processing?

Several analytical techniques are used during aseptic processing. Marie-Sophie Quittet, Strategic Projects Manager at Adragos Pharma, highlights the following:

Raman and near-infrared spectroscopy deliver fast, non-invasive identification and concentration verification for raw materials, buffers, and protein solutions, reducing both cycle times and sampling risk.

Tunable diode laser absorption spectroscopy and other related laser headspace analytics enable quantitative, 100% residual oxygen/moisture checks, which is tightly linked to product stability and CCI performance.

Deterministic CCI (high-voltage leak detection, vacuum/pressure decay) provides sensitive, scalable integrity testing with strong regulatory acceptance.

Automated visual inspection, increasingly aided by advanced image analysis, yields consistent particle/defect detection with lower false rejects versus manual inspection.

Biofluorescent particle counters add near-real-time viable air insight to complement traditional environmental monitoring.

Core QC methods including high-performance liquid chromatography (HPLC)/ultra-performance LC, ultraviolet-visible, osmolality, pH, total organic carbon, and sub-visible particle analysis such as micro-flow imaging, remain indispensable for product release, providing specificity and precision for identity, purity, potency, and particles across small-molecule and biologic injectables.

How do regulations drive analytical strategies?

Regulations set the framework and pace of adoption of analytical methods and technologies, according to Quittet. That is why, notes Scott Goldstein, vice president of strategic partnerships with Argonaut Manufacturing Services, a strong quality and regulatory team is instrumental in assuring the facility, analytical technologies and environmental monitoring are aligned with constantly changing regulatory requirements for aseptic processing.

As an example, Quittet points out that Annex 1 of the European Union’s good manufacturing practice guidelines (3) emphasizes a holistic contamination control strategy, using barrier technologies, continuous environmental monitoring, PUPSIT, trending, and strong data integrity, which all drive closed, real-time analytical methods. In the United States, FDA’s aseptic processing guidance (1), ISO 14644 (4), and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) (5) reinforce cleanroom classification, environmental monitoring, and process control basics.

Method validation and lifecycle management are governed by the International Council for Harmonisation’s (ICH) Q2(R2)/Q14 (6), while ICH Q8–Q10 (7) and Q9(R1) (8) emphasize quality-by-design (QbD) and risk management. 

 (USP) chapters—<71> sterility (9) and <85> endotoxin including recombinant Factor C as a validated alternative (10), <787>/<788> particulates (11,12), <1207> CCI (13), <1223> rapid microbiological methods (14), and <1229> sterilization (15)—define baseline expectations.

“Regulators expect scientific justification for alternative/rapid methods, robust electronic records and cybersecurity, meaningful trending with timely action, and formal governance for models/algorithms within validated, change-controlled systems, including periodic performance verification and management review,” Quittet concludes.

What are the essential attributes of analytical methods used in aseptic processing?

The essential attributes of analytical techniques used for release, characterization, in-process control(s), and stability testing during aseptic processing of drug substances (DS) and drug products (DP) that ensure both high performance and regulatory compliance can be, says Gangurde, divided into three main categories. The methods used should be reliable, robust, reproducible and amenable to method qualification and validation; selected and developed to assess safety, quality and efficacy; and include the use of appropriate reference standards and materials, particularly for determining critical attributes such as titer and potency of the DP. Furthermore, methods must minimize the risk of sample contamination, while delivering fast, reliable decisions, Quittet observes.

According to Quittet, preferred attributes should:

include closed or noninvasive operations that are compatible with isolators/restricted access barrier systems (RABS), single-use assemblies, and exposure to vaporized hydrogen peroxide (VHP)/H

be rapid or provide real-time results with sensitivity and specificity matched to the critical attribute (e.g., headspace oxygen, sub-visible particles, low bioburden/endotoxin) and robust against matrix effects and process drift

integrate seamlessly with supervisory control and data acquisition/DCS distributed control system/manufacturing execution system/electronic batch manufacturing record, enabling automated, secure data capture, and alarm management

be maintainable in Grade A/B conditions, resilient to cleaning/decontamination, scalable across sites, and supported by credible vendors with global service and spares.

What factors are important when selecting and transferring methods for aseptic processes?

Method selection primarily depends on the quality and efficacy requirements of the material/product in question. Other important factors, according to Gangurde, include ease of development, tech-transfer requirements, availability and procurement of raw materials, and the equipment needed. He also notes that wherever applicable, orthogonal methods should be selected and applied.

Leveraging experience to determine the optimal starting point can be a real differentiator in assuring appropriate methods are identified and evaluated prior to method development and qualification of analytical testing, according to Goldstein.

When transferring a method, there are additional considerations. “When a drug developer is transferring a method to a contract manufacturer, it has the responsibility to ensure the method is robust and accurate and able to detect any stability issues, anticipate any problems that may exist or arise with the method, and be confident the contract manufacturer has the ability to effectively implement it,” explains Quittet.

Which advances are enhancing the monitoring and control of aseptic processes?

The pharmaceutical industry is highly innovative, and numerous advances in both general technologies and specific analytical techniques are helping to improve the monitoring and control of aseptic processes.

With respect to more general developments, Gangurde points to single-use systems, which eliminate the need for extensive cleaning and sterilization between batches and minimize cross-contamination risks; barrier isolators and restricted access barrier systems, which create physical barriers to minimize microbial contamination; microfluidic devices, which enable rapid microbial detection, supporting real-time decision-making and reducing operational bottlenecks (16); and process analytical technologies, which enable real-time monitoring and control of critical process parameters and integration of QbD design principles into manufacturing (17). Real-time monitoring of cleanrooms (18) and use of big-data analytics (19) are also providing invaluable insights.

“These and other advancements collectively improve the efficiency, sterility, and safety of aseptic processes in biopharmaceutical manufacturing,” contends Gangurde.

Goldstein highlights some specific techniques as being highly impactful. “Real-time viable and non-viable particulate monitoring has been key to assessing issues that might arise during aseptic processing and allows for quicker and more efficient investigation techniques,” he notes. “In addition, fully automated sampling allows for drastic reduction in potential operator contamination during these sampling steps, helping to speed up the process and release of the product while assuring the highest level of quality,” he continues. Automation and digitalization of analytics for aseptic processing are also supporting more rapid testing (17).

What role will AI and ML play in aseptic processing analytics?

AI and machine learning (ML) not only will be important for the future of aseptic processing analytics; they are already in use today. For instance, AI has started to become integrated into filling lines, according to Goldstein, but is not yet making an impact with QC techniques. Both AI and ML are being used to improve monitoring and control of aseptic processes, Gangurde agrees. AI-driven predictive maintenance, automated environmental monitoring, and process control applications are prime examples.

In the latter case, ML is being used to optimize process parameters in real-time, providing data on product quality. Operators can also simulate and test process changes before implementation, which helps with tech-transfer, adaptation, and scaling of processes (20). In addition, ML is being applied in visual inspection systems, notes Quittet, where it is used to limit the rejection rate of good vials and accelerate the release of product batches.

Companies such as GlaxoSmithKline, Pfizer, Merck, Rocher, and Novartis have all implemented AI-driven programs in aseptic processing applications (21).

Looking forward, Gangurde believes an increased dependence on AI and ML is inevitable, as both can improve the overall process of drug development to bring therapies to patients in need. “AI will make a big impact in the automation of aseptic processes and minimizing risk to the patient,” Goldstein adds.

Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing —Current Good Manufacturing Practice

O’Connor, R. Aseptic Processing: A Primer. 

https://www.biopharminternational.com/view/aseptic-processing-primer

EC. Annex 1, Manufacture of Sterile Medicinal Products. 

, The Rules Governing, Medicinal Products in the European Union. Volume 4, 2010.

Cleanrooms and Associated Controlled Environments Part 1: Classification of Air Cleanliness by Particle Concentration

PIC/S Guide to Good Manufacturing Praxtice for Medicinal Products Annexes

, Annex 1 (Manufacture of sterile medicinal products) July 2018. 

https://www.fda.gov.ph/wp-content/uploads/2022/12/PE-009-14-GMP-Guide-Annexes.pdf

USP. General Chapter <71>, Sterility Test. 

 (US Pharmacopeial Convention, Rockville, MD, 2009).

USP. General Chapter <85>, Bacterial Endotoxins. 

 (US Pharmacopeial Convention, Rockville, MD, 2017).

USP. General Chapter <787>, Subvisible Particular Matter in Therapeutic Protein Injections. 

US Pharmacopeial Convention, Rockville, MD, 2014).

USP. General Chapter <788>, Particulate Matter in Injections. 

 (US Pharmacopeial Convention, Rockville, MD, 2007).

USP. General Chapter <1207>, Sterile Product Packaging–Integrity Evaluation. 

 (US Pharmacopeial Convention, Rockville, MD, 2016).

USP. General Chapter <1223>, Validation of Alternative Microbiological Methods. 

 (US Pharmacopeial Convention, Rockville, MD, 2015).

USP. General Chapter <1229>, Sterilization of Compendial Articles. 

 (US Pharmacopeial Convention, Rockville, MD, 2022).

Mirasol, F. How Miniaturized Analytics Are Transforming Aseptic Bioprocessing Control. 

https://www.biopharminternational.com/view/how-miniaturized-analytics-are-transforming-aseptic-bioprocessing-control

Challener, C.A. Advances in Digitalization and Automation of Aseptic Processing. 

https://www.pharmtech.com/view/advances-in-digitalization-and-automation-of-aseptic-processing

Spencer-Jolliffe, N. Continuous Monitoring Expands Aseptic Knowledge and Data in Real Time. 

www.pharmaceutical-technology.com/features/continuous-monitoring-expands-aseptic-knowledge-and-data-in-real-time/

Advanced Analytics: Driving Cleanroom Excellence in Pharmaceutical Manufacturing. 

https://cleanroomtechnology.com/advanced-analytics-driving-cleanroom-excellence-in-pharmaceutical-manufacturing

Vuolo, M.; Koeth, C.; and Wherry, R.J. Enhanced Intervention Detection in Aseptic Fill Using AI/ML. ISPE 

https://ispe.org/pharmaceutical-engineering/may-june-2023/enhanced-intervention-detection-aseptic-fill-using-aiml

“How AI & Machine Learning Are Transforming Aseptic Processing,”Blog post. 

https://www.vonlanthenevents.com/en/ai-transforming-aseptic-processing

Aseptic processing in pharmaceutical manufacturing requires robust analytical methods to ensure product sterility, safety, and quality. These methods must be reliable, reproducible, and validated, with a focus on minimizing contamination risks. Regulatory frameworks, such as those from the FDA and ICH, guide the adoption of these methods, emphasizing quality-by-design and risk management. Advances in technology, including AI and machine learning, are enhancing process monitoring and control, enabling real-time decision-making and improving efficiency. The integration of these technologies is crucial for maintaining high standards in aseptic processing.

Ensuring quality, sterility, and regulatory compliance are essential when choosing analytical methods.

Analytical Strategies for Aseptic Processing

The week’s coverage discusses leveraging agentic AI, sustainability, and resilient supply chains to transform global drug development and safety.

PharmTech Weekly News Roundup – Week of January 12, 2026

In this PharmTech video feature, we highlight the week’s industry news in an easy-to-consume, fun format. New roundups will drop every Friday, so be sure to come back each week.

Collectively, the week’s coverage discusses the pharmaceutical industry’s recent developments and current regulatory landscape. Read on for recaps of each story we’ve covered.

Dycem Celebrates 60 Years of Contamination Control

Dycem celebrates sixty years of innovation in contamination control and high-friction polymers to ensure safety in global regulated industries.

EMA and FDA Collaborate on Framework for AI Use in Drug Development

FDA and EMA establish ten guiding principles for safe, ethical AI application across the entire biopharmaceutical product development lifecycle.

Industry Outlook 2026: Navigating AI, Sustainability, and Operational Resilience

Industry experts predict 2026 will be defined by agentic AI adoption, sustainable manufacturing practices, and resilient, geographically diversified supply chains.

Integrating AI and Machine Learning in Drug Discovery and Development

Pharmaceutical companies leverage AI and machine learning to accelerate early-stage drug discovery, utilize digital twins, and streamline regulatory workflows.

Jubilant Biosys Announces New Facility in India

Jubilant Biosys expands its Noida facility to double chemistry capacity, integrating discovery and early-phase scale-up for pharmaceutical research clients.

Pharma Manufacturing Professionals Are Staying Put Despite Growing Uncertainty

Industry surveys show pharmaceutical manufacturing professionals face rising job insecurity but remain committed to the sector for intellectual stimulation.

Pharmaceutical Supply Chain Resilience in a Shifting Market

Biotech companies mitigate geopolitical risks by auditing supply chains and implementing multi-sourcing strategies to ensure stable essential material access.

Single-Use Systems Enable Commercial-Scale CGT Manufacturing

Single-use systems and robotic automation industrialize cell and gene therapy 

manufacturing by reducing validation burdens and enhancing process scalability.

SÜDPACK Medica to Unveil Next-Generation Sustainable Packaging and Streamlined Services at Pharmapack Europe 2026

SÜDPACK Medica introduces recyclable mono-material blister packaging and streamlined procurement services to advance sustainability in pharmaceutical and medical sectors.

The Transformative Potential of AI to Enhance Patient Treatment

AI technology enhances patient care by prioritizing clinical trials for unmet medical needs and enabling precision prescribing through digital health.

Tjoapack Expands Bottle Packaging at Netherlands Facility

Tjoapack boosts global capacity by adding flexible, GMP-compliant bottle packaging lines in the Netherlands while expanding its United States footprint.

Videos

Jane Zhang is Co-Founder & Co-CEO, ETCH Sourcing.

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

Question mark background | Image Credit: © Leigh-Prather - © Leigh Prather - stock.adobe.com

Q: My company is developing a new product and would like to establish a secure supply chain early on in our development phase. What advice can you provide to help achieve that objective?

A: Establishing and maintaining a secure supply chain requires a strong relationship between all the departments working on the product development process, including the purchasing department. Most supply chain failures don’t start at scale, but during development. When purchasing controls are treated as a downstream activity, companies can unintentionally introduce quality, regulatory, and supply risks that become costly or impossible to unwind in the future. By increasing upfront collaboration with the purchasing group decisions and sharing specifications and material needs, procurement of materials and services can extend to factor in multiple dimensions of quality, risk, and lifecycle performance in addition to controlling expenses.

To help guide the industry, the Parenteral Drug Association (PDA) is revising 

ANSI/PDA Standard 001-2020: Enhanced Purchasing Controls to Support the Bio-Pharmaceutical, Pharmaceutical, Medical Devices and Combination Products Industries

. As stated in the document, “Historically, not all organizations have systems that ensure shared responsibilities for making purchasing decisions or define who is accountable for purchasing decisions and/or what measures/justifications or other controls/criteria are in place to maintain product quality. Although an independent quality unit is often considered the unit with accountability for supplier suitability, fitness, reliability and trustworthiness, other functions within companies share this responsibility” (1). In practice, this means supplier decisions cannot sit within a single function but must be addressed through collaboration across all functions.

The purpose of this document “is to provide guidance on the application of purchasing controls for companies that procure goods and services from GxP-relevant suppliers, whose product or service may affect product quality, patient safety, or regulatory compliance. The guidance applies across the full product life cycle from development through commercialization to discontinuation. It encompasses materials and components, contracted operations such as CMOs, design and logistics services, GxP-critical digital systems and technical service providers” (1).

Often, the development phase of a product has many uncertainties associated, and supply decisions are made on the basis of ‘just for development’ consideration. However, these types of actions can easily develop into a situation where a single supplier ends up with an artificial knowledge advantage over others and removes competitiveness from later on in the process. One of the first actions the development team should take is to develop a dialog and a process for procurement with the purchasing department. The purchasing and quality departments should work together to define the steps the company should employ to determine if a new supplier is needed, establish the selection requirements for suppliers (this includes initial qualification and approval), establish a quality agreement with the supplier which includes how the supplier will be monitored for performance overtime, and establish frequent communication touch-points between the supplier, the purchasing department, and the quality department. Consideration also needs to address how the supplier and the purchaser work together in case of dispute regarding the quality of the material.

A secure and resilient supply chain depends on clear ownership of accountability and alignment across multiple areas. Developmentis accountable for defining what the product needs to do and providing the expertise for the critical performance characteristics, intended use, risk tolerance, and any known suppliers. Quality is accountable for determining what is acceptable. This includes evaluating, qualifying, approving, and maintaining clear records of acceptable and unacceptable suppliers for specific materials and services. Purchasingis accountable for determining who can reliably deliver. This includes sourcing products and services at a competitive price, from a qualified supplier, from a qualified source, in a way that complies with other company procurement expectations and requirements (1).

Maintaining and establishing a sustainable supply chain is achievable when company departments work together and establish acceptable procedures, document actions, and delineate responsibilities with respect to supplier interactions. Organizations that treat purchasing as a strategic partner, not a transactional function, build supply chains that scale with confidence and plan for future potential risks early on. 

. April 2020. *This document revision is in the public review commenting stage and should be released in 2026.

https://www.pda.org/bookstore/product-detail/5596-ansi-pda-standard-001-2020

Establishing a secure supply chain in product development requires collaboration across departments, particularly with purchasing. Early integration of purchasing controls can mitigate quality, regulatory, and supply risks. The Parenteral Drug Association's revised standard emphasizes shared responsibility in purchasing decisions, ensuring product quality and compliance. Development, quality, and purchasing departments must align on supplier selection, performance monitoring, and dispute resolution. Treating purchasing as a strategic partner rather than a transactional function fosters a resilient supply chain, capable of scaling and addressing potential risks throughout the product lifecycle.

The development, quality, and procurement teams should work together to determine which materials and suppliers are needed, says Jane Zhang, Co-Founder & Co-CEO, ETCH Sourcing, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company.

Ensuring the Supply Chain through Purchasing Controls 

Selective focus on blue-white capsule pills in blister pack. Pharmaceutical industry. Drug package. Pharmaceutics concept. Drug use in hospital or drugstore product. Health budget. Global healthcare. | Image Credit: ©

 which is being held in Paris on January 21–22, 

 (Booth 4F12) will showcase a portfolio designed to address sterility and sustainability requirements, headlined by the expansion of the company’s PharmaGuard recyclable blister concept and the launch of the MedHub service (1).

How is mono-material blister technology being advanced?

According to the company, SÜDPACK Medica’s PharmaGuard represents a significant shift away from traditional multi-layer composites that complicate recycling streams (1). Originally known for its award-winning transparent film, the line has expanded to include a white blister film. This new iteration offers high opacity and improved legibility for printed dosage information, which is critical for patient safety and regulatory compliance.

From a technical perspective, the PharmaGuard solution is a polypropylene (PP)-based mono-material. It is engineered to be free from phthalates, vinyl, PFAS, and halogens, addressing growing toxicological and environmental concerns. Despite its simplified material structure, it maintains high-performance characteristics essential for solid oral dosage forms, including a water vapor barrier and "outstanding push-through performance". Crucially for manufacturers, the material is designed for reliable processability on standard packaging machinery, minimizing the need for extensive line re-tooling.

What is the sustainability and lifecycle impact?

For scientists and sustainability officers tasked with reducing a product's carbon footprint, the environmental metrics of PharmaGuard are supported by the data. According to an ISO 14040/44-verified Life Cycle Assessment (LCA) conducted by Sphera, this PP-based solution has a significantly lower climate impact compared to conventional composite materials made of aluminum and polyethylene terephthalate (PET).

Beyond blister packs, the MedGuard brand offers a comprehensive range of low-particle packaging concepts tailored for medical devices and sensitive diagnostic products. These systems include robust rigid and flexible films, as well as specialized pouch concepts manufactured under controlled clean room conditions.

The technical versatility of the MedGuard line allows materials to be equipped with specific barrier and peel properties. These are compatible with various lidding systems, including:

For surgical kits, syringes, and ampoules, the thermoformable rigid films are based on recyclable PET and PP, ensuring that even complex tray packaging aligns with sustainability objectives without sacrificing the stability or sterility of the process chain.

How does MedHub optimize the supply chain?

Recognizing the industry's need for agility, SÜDPACK is introducing MedHub, a service designed to streamline the procurement of pre-made medical bags and pouches (1, 2). This service targets customers requiring steady supplies of standard formats with "minimal effort and reliable delivery".

Customers can order high-quality, pre-made pouches in standard sizes and defined batch quantities either by phone, email, or online. MedHub packaging solutions are always in stock an fulfill the stringent quality requirements of the healthcare industry (2)

All MedHub products are manufactured in ISO-classified clean rooms and backed by standardized certifications to meet the highest safety standards for medical use. The service allows for the fast ordering of three-side seal pouches in various sizes and material combinations, tailored to specific oxygen, moisture, and light barrier requirements.

Pre-made pouches can be used at various stages to package products such as stoppers, filters, or connectors. They can also be used as simple transfer packaging for items such as glass vials, ampoules, or syringes, which are essential for administering liquid parenteral drugs and must remain completely sterile prior to filling (2).

Three-side seal pouches are made from film and Tyvek, which makes them sterilizable, puncture-resistant, and highly resistant to moisture and provides product protection and fast, clean opening, even in high-pressure environments.SÜDPACK also offers three-side seal pouches made of PA/PE in various sizes. These pouches provide a dependable microbial barrier and are also suitable for gamma sterilization (2).

How does SÜDPACK Medica serve the pharma industry?

Headquartered in Baar, Switzerland, SÜDPACK Medica leverages the technological leadership of the broader SÜDPACK Group, particularly in the coextrusion of polymer-based film solutions. With production sites across France, Germany, Switzerland, and the Netherlands, the company utilizes a specialized team of experts in polymer science and process engineering to support global pharmaceutical clients in implementing demanding packaging configurations.

As the industry looks toward 2026, the integration of recyclable polymers into high-barrier sterile packaging marks a pivotal step in the evolution of pharmaceutical manufacturing.

SÜDPACK Medica. A Strong Partner to the Healthcare Industry: SÜDPACK Medica at PharmaPack 2026 in Paris. Press Release. Jan. 15, 2026. https://www.suedpack.com/en/suedpack-group/news/press-releases/press-detail-view/a-strong-partner-to-the-healthcare-industry-suedpack-medica-at-pharmapack-2026-in-paris

SÜDPACK Medica. SÜDPACK Medica launches new service for the healthcare industry. Press Release. Jan. 8, 2026. https://www.suedpack.com/en/suedpack-group/news/press-releases/press-detail-view/suedpack-medica-launches-new-service-for-the-healthcare-industry

SÜDPACK Medica is advancing mono-material blister technology with its PharmaGuard line, which shifts from traditional multi-layer composites to a recyclable polypropylene-based solution. This innovation addresses environmental concerns while maintaining high-performance characteristics essential for solid oral dosage forms. The MedGuard brand offers versatile packaging for sterile medical devices, aligning with sustainability goals. Additionally, the MedHub service optimizes the supply chain by providing pre-made medical bags and pouches, ensuring reliable delivery and compliance with stringent quality standards. SÜDPACK Medica's efforts mark a significant step in integrating recyclable polymers into pharmaceutical packaging.

The company will be highlighting its PharmaGuard recyclable blister solution, MedGuard line, and MedHub procurement service. 

Guiding Principles for AI Use in Drug Development | Created with Canva

The European Medicines Agency (EMA) and FDA, in a significant step in the regulatory oversight of computational tools in the pharmaceutical industry, have established ten core principles intended to support the safe and ethical 

throughout the entire path of a medicine, from early laboratory research to the manufacturing floor and eventual post-market oversight (1,2). This alignment provides a necessary framework to manage the complexity and dynamic nature of these tools, ensuring that the evidence produced is both accurate and reliable.

What are the ten core principles established for pharmaceutical AI?

The joint initiative identifies specific areas where pharmaceutical developers and technical standards organizations can align their practices (2). These principles are as follows:

1. Human-centric by design: The development and use of AI technologies align with ethical and human-centric values (2,3).

2. Risk-based approach: The development and use of AI technologies follow a risk-based approach with proportionate validation, risk mitigation, and oversight based on the context of use and determined model risk (2,3).

3. Adherence to standards: AI technologies adhere to relevant legal, ethical, technical, scientific, cybersecurity, and regulatory standards, including Good Practices (GxP) (2,3).

4. Clear context of use: AI technologies have a well-defined context of use (role and scope for why it is being used) (2,3).

5. Multidisciplinary expertise: Multidisciplinary expertise covering both the AI technology and its context of use are integrated throughout the technology’s life cycle (2,3).

6. Data governance and documentation: Data source provenance, processing steps, and analytical decisions are documented in a detailed, traceable, and verifiable manner, in line with GxP requirements (2,3).

7. Model design and development practices: The development of AI technologies follows best practices in model and system design and software engineering and leverages data that is fit-for-use, considering interpretability, explainability, and predictive performance (2,3).

8. Risk-based performance assessment: Risk-based performance assessments evaluate the complete system including human-AI interactions, using fit-for-use data and metrics appropriate for the intended context of use, supported by validation of predictive performance through appropriately designed testing and evaluation methods (2,3).

9. Life cycle management: Risk-based quality management systems are implemented throughout the AI technologies’ life cycles, including to support capturing, assessing, and addressing issues (2,3).

10. Clear, essential information: Plain language is used to present clear, accessible, and contextually relevant information to the intended audience, including users and patients, regarding the AI technology’s context of use, performance, limitations, underlying data, updates, and interpretability or explainability (2,3).

How will these standards impact drug development and manufacturing?

The implementation of these principles is expected to facilitate more efficient pathways for both traditional medicines and biological products, as the term drug in this context encompasses both categories across various jurisdictions (1-3). In a message to American Association of Pharmaceutical Scientists members (4), Mark Arnold, PhD, owner and principal, Bioanalytical Solution Integration, wrote "Today, after several months of collaboration, the FDA and the European Medicines Agency… are releasing a common set of 10 guiding principles to inform, enhance, and promote the use of [AI] generating evidence across all phases of the drug product life cycle. The integration of AI in drug development has the potential to transform the way drugs are developed and evaluated, ultimately improving health care. AI technologies are anticipated to help promote innovation, reduce time-to-market, strengthen regulatory excellence and pharmacovigilance, and decrease reliance on animal testing by improving the prediction of toxicity and efficacy in humans."

The joint principles mean that future regulatory submissions involving AI will likely require more rigorous multidisciplinary integration and documented data provenance to meet good manufacturing practices expectations. As noted by Arnold, "As an advisor to an AI company, and a user of AI software, these are 10 short and clear guides." By adhering to these standards, companies can better prepare for future jurisdictional guidelines while contributing to a global innovation environment that prioritizes patient safety. European Commissioner for Health and Animal Welfare Olivér Várhelyi stated in an EMA news release, "The guiding principles of good AI practice in drug development are a first step of a renewed EU-US cooperation in the field of novel medical technologies. The principles are a good showcase of how we can work together on the two sides of the Atlantic to preserve our leading role in the global innovation race, while ensuring the highest level of patient safety" (1). This foundational work is expected to evolve alongside the technology, maintaining a focus on demonstrated quality, efficacy, and safety (2).

EMA and FDA Set Common Principles for AI in Medicine Development. Press Release

Guiding Principles of Good AI Practice in Drug Development

Artificial Intelligence for Drug Development. Guiding Principles of Good aI Practice in Drug Development

American Association of Pharmaceutical Scientists. AAPS Community Digest  for Wednesday January 14, 2026. Email Newsletter.

The European Medicines Agency and FDA have established ten core principles to guide the ethical and safe application of AI in the pharmaceutical industry. These principles cover the entire lifecycle of a medicine, from research to post-market oversight, ensuring AI tools produce accurate and reliable evidence. The initiative aims to align practices among pharmaceutical developers and technical standards organizations, promoting innovation, reducing time-to-market, and enhancing regulatory excellence. This collaboration is expected to transform drug development, improve healthcare, and maintain a focus on quality, efficacy, and safety.

FDA and EMA have issued 10 guiding principles for AI in drug development with the intended goal of ensuring safety and innovation across the life cycle of a drug.

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