Behind the Headlines Episode 27

Ask the Expert

Small Molecules, APIs, and Excipients—Trends, Challenges, and Opportunities

Drug Digest September 2025

Artificial intelligence, machine learning, and novel instruments are helping drug developers.

Enhancing Bioanalysis and Drug Development with Advanced Tools and Technologies

J.P. Morgan Report Lists Biologics, Obesity, China

Top Trends Reshaping Pharma R&D

Felicity Thomas is the former Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Oral solid dosage (OSD) forms are commonplace within the pharmaceutical industry thanks to several advantages such a form can offer, including convenience of manufacture, ease of administration, and cost-effectiveness. According to market research, the OSD market outlook is favourable and expected to experience continued growth, driven by the low production cost—particularly within developing nations (1).

The manufacture of all pharmaceutical finished dosage forms, including OSD, must adhere to regulatory guidance and specifications to ensure quality and safety of the products are maximized. Current good manufacturing practices (CGMPs), for example, are the minimum standards that must be met and require a proactive quality approach be taken to the manufacture of finished products so that any risks, such as contamination, are minimized or eliminated (2).

CGMP requirements tend to be general and allow for manufacturers to implement quality controls on an individual basis. “The general expectations for CGMP, relating to OSD forms, revolve around ensuring consistent and acceptable product quality and safety,” confirms Dave DiProspero, senior fellow, Pharmaceutical Process, CRB. “This [practice] follows the traditional five Ps of GMP: people, premises, processes, products, and procedures. Regulatory guidance and good practices are based on these five Ps and focus on protecting the product from contamination and preventing any mix ups. Operations must be fully understood and in control.”

OSD regulatory guidance has been relatively current for many years, explains DiProspero, which is contrary to other areas of manufacturing, such as the sterile environment, where recent updates have been made via documents like Annex 1. “The US Food and Drug Administration (FDA) has issued various technical guidance documents [for OSD forms], most recently around continuous manufacturing; however, the most typical industry guidance is related to ISPE [International Society for Pharmaceutical Engineering Operations] OSD Baseline Guide Volume 2 and ISPE Good Practice Guide Continuous Manufacturing of OSD Forms” (3,4).

Within Europe, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted updated manufacturing guidelines for finished dosage forms in 2017 (5). These updated guidelines addressed legislative requirements and followed the format of the common technical document (CTD) module 3 dossier. Additionally, the changes to manufacturing practices as related to the global, complex supply chains were reflected.

Although no major changes are expected to be made to GMP guidance for OSDs in the near future, DiProspero does point out that regulators are focusing more heavily on manufacturers of nutraceuticals and dietary supplements. “More guidance and closer alignment with [prescription] products are likely to occur in the years ahead,” he says. “Many of the major dietary supplement manufacturers are already greatly improving their facilities and processes to align with pharma facilities.”

“Continuous manufacturing has been the leading new processing platform paving its way in the development of new OSD products and conversion from traditional batch products,” notes DiProspero. It is known that regulatory authorities around the world have proactively supported the use of innovative manufacturing approaches, such as continuous manufacturing (6). “FDA have reacted very positively and strongly in advocating this platform and providing guidance on its use and implementation,” DiProspero confirms.

Recently, there has been greater harmonization around the regulation of continuous manufacturing, DiProspero continues. “The 2022 ISPE Continuous Manufacturing Good Practice Guide was heavily based on establishing a set of minimum equipment requirements for each type of system to function as a part of an integrated process train, making it easier for manufacturers and equipment suppliers to identify and define minimum attributes,” he says. “The March 2023 FDA guidance for industry (Q13 

Continuous Manufacturing of Drug Substances and Drug Products

) describes scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of continuous manufacturing” (7).

“[Further,] FDA’s guidance builds on existing International Council for Harmonisation (ICH) quality guidance (Q13), providing clarification on continuous manufacturing concepts and describing scientific approaches and regulatory considerations specific to continuous manufacturing of drug substances and drug products,” DiProspero adds (8).

Ensuring compliance and quality in modern practices

Currently, to ensure compliance and improved quality of modern finished products, companies are working on improved process containment and closed or integrated systems, DiProspero highlights. “It has always been common to contain and close when dealing with hazardous/potent compounds, but [there are now] improved systems and operations for non-potent and non-hazardous,” he remarks. “Minimizing dust, controlling feed, and improving ergonomics and operator safety are among some of the most common best practices being seen in modern powder handling and OSD manufacturing operations.”

Baseline Guide Vol. 2: Oral Solid Dosage Forms 3rd Edition

. Guidance Document, November 2016.
4. ISPE. 

Good Manufacturing Practice Guide: Continuous Manufacturing of Oral Solid Dosage Forms

. Guidance Document, March 2022.
5. EMA. 

Guideline on Manufacture of the Finished Dosage Form

. Guidance Document, July 2017.
6. Wahlich, J. Review: Continuous Manufacturing of Small Molecule Solid Oral Dosage Forms. 

Q13 Continuous Manufacturing of Drug Substances and Drug Products

. Guidance for Industry, March 2023.
8. ICH. Q13, 

Felicity Thomas is the European/senior editor for Pharmaceutical Technology Group.


Vol. 35, No. 8
August 2023
Pages: 32–33

When referring to this article, please cite it as Thomas, F. Ensuring OSD Quality and Safety. 

Articles

Current good manufacturing practices for oral solid dosage forms protect the product from contamination and potential errors.

Ensuring OSD Quality and Safety

As Europe experiences extreme weather conditions—with sweltering temperatures in Southern areas, wildfires destroying parts of the Greek islands, and deadly storms affecting other parts of the region—it is becoming clear that more action needs to be taken to tackle climate change. For the pharmaceutical industry, tackling climate change is not just about cutting emissions but also about combatting the adverse effects on health that are linked to the warming world.

In 2021, the World Health Organization (WHO) reported that “climate change is the single biggest health threat facing humanity” and predicted that, between 2030 and 2050, it will cause approximately 250,000 extra deaths per year (1). Shortly after WHO’s report, during the United Nations Climate Change Conference of the Parties (COP26), held between 31 Oct. and 13 Nov. 2021, a public-private partnership—the Sustainable Markets Initiative (SMI) Health Systems Task Force—was launched, aimed at speeding up the delivery of net zero healthcare (2).

Members of the Task Force, who include CEOs of large biopharmaceutical companies and public bodies, collaborated on industry commitments that will help support the transition to sustainable healthcare. A year later, during the COP27 meeting in 2022, the Task Force set out some core commitments, actions, and recommendations for industry that focused on three priority areas—“supply chain, patient care pathways decarbonization, and the use of digital innovation in clinical research” (2).

The joint action of the members involved in the Task Force has continued with a further scaling up of targets for suppliers in the industry to try and reach a net zero target. Most recently, Task Force members published an open letter stressing the criticality of action on climate change within the industry, which laid out minimum supplier targets for climate and sustainability across the value chain (3).

Ultimately, climate change is already impacting global health negatively and only a significant collaborative effort is going to reduce that effect. As the Task Force members wrote, “Healthcare supply chains must become greener, more efficient, and circular … Shifting to net zero, climate resilient health systems cannot be achieved in siloes. We must collaborate, across the sector and across borders, to secure a healthier tomorrow” (3).

Open Letter on Supplier Targets from Members of the Sustainable Markets Initiative Health Systems Task Force

When referring to this article, please cite it as Thomas, F. A Healthier Tomorrow? 

Only a significant joint effort across the supply chain will help to make healthcare more sustainable and reduce the impact of climate change on global health.  

A Healthier Tomorrow?

Cheryl Barton is director of PharmaVision, 

On 5 May 2023, the World Health Organization (WHO) declared that COVID-19 was no longer a public health emergency following a decrease in COVID-19 deaths, hospitalizations, and intensive care unit admissions across the globe over the past several months (1). On 6 July 2023, the European Medicines Agency (EMA), the European Commission (EC), and the Heads of Medicine Agencies (HMA) announced they would be phasing out the extraordinary COVID-19 regulatory flexibilities introduced in August 2022 in response to the pandemic (2).

Extraordinary regulatory flexibilities introduced during COVID-19

The extraordinary regulation encompassed several different aspects to ensure the continuity of supplies of medicines during the public health emergency. These included greater flexibility for:

good manufacturing practice (GMP) and good distribution practice (GDP) issues

issues related to marketing authorization (MA) and MA procedures

manufacturing and importation of finished products and APIs (3).

EMA’s quick response to the crisis highlighted the need for rapid and coordinated feedback to developers and the importance of continued dialogue with them, to ensure that adaptions to the regulatory environment were workable for the industry (4).

From this point onwards, the regulatory flexibilities that were introduced jointly by the EC, EMA, and HMA during COVID-19 will no longer be granted (3). For products that have already received approved labelling flexibilities, such as COVID-19 vaccines with English-only labelling, the application will be extended until the end of 2023 to prevent any disruptions to supplies; after which time, manufacturers will revert to the original legislations on product labelling (3).

Conversely, on-site GMP and GDP inspections have been reinitiated following their postponement or implementation of remote visits performed during the pandemic (3). GMP and GDP certificates have been extended until the end of 2023, and the GMDP inspectors working group will provide further details over the coming months following a review of information gleaned from remote working of qualified persons during the pandemic (5).

Future regulation, preparedness, and response tools

The COVID-19 pandemic highlighted the importance of deploying a coordinated EU-wide strategy and revealed some vulnerabilities in the current system, including limitations in the regulations, preparedness, and response tools (6). In November 2020, the EC proposed a series of measures, including a revised regulation on serious cross‑border threats to health and proposals to extend the mandates of EMA and the European Centre for Diseases Prevention and Control (ECDC) in public health emergencies, to create a European Health Emergency Preparedness and Response Authority (HERA) (7). In February 2021, the EC also announced that it may consider targeted amendments to the pharmaceutical legislation including developing new regulatory tools to introduce an emergency authorization of vaccines at the EU level with shared liability among member states, during public health threats (6).

On 26 April 2023, EMA published two legislative proposals—a new regulation 2023/0131 and a new directive 2023/0132—to replace the current European Union (EU) regulatory framework for all medicines (8,9). As part of the overhaul, EMA plans to introduce some contingency planning procedures including the compilation of an EU-wide list of critical medicines and recommendations to companies to strengthen the supply chains should the need arise. Under the new proposal, all MA holders will need to put in place a shortage prevention plan for each medicine on the market, any critical shortages would need to be reported to EMA. In addition, the new regulation provides temporary measures such as emergency MA for crisis‑related medicines allowing the EU to take control of drug manufacturing in response to an emergency, this controversial point has raised concerns amongst some pharma industry leaders (10).

The new regulatory framework is currently being reviewed by the European Parliament and the European Council and a decision on the proposed reform is unlikely to take place before the 2024 EU parliamentary elections. In the meantime, data are being gathered by EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products regarding manufacturers’ experience of the COVID-19 regulatory flexibilities (11). EMA will then reflect on how lessons learned during the pandemic can inform best practices for confronting medicine shortages in the presence of new and emerging health challenges in the future (2).

Statement on the Fifteenth Meeting of the IHR (2005) Emergency Committee on the COVID-19 Pandemic

Phasing out of Extraordinary COVID-19 Regulatory Flexibilities

Questions and Answers on Regulatory Expectations for Medicinal Products for Human Use During the COVID-19 Pandemic

, 11 Aug. 2022.
4. Cavaleri, M.; Sweeney, F.; Gonzalez-Quevedo, R.; Carr, M. Shaping EU Medicines Regulation in the Post-COVID-19 Era. 

, 9, 100192.
5. Taylor, N.P. Euro Roundup: EMA Starts Phasing Out Regulatory Flexibilities Provided During the COVID-19 Pandemic. 

, RAPS, 13 July 2023.
6. Beaussier, A.; Cabane, L. Strengthening the EU’s Response Capacity to Health Emergencies: Insights from EU Crisis Management Mechanisms. 

HERA Incubator: Anticipating Together the Threat of COVID-19 Variants

Reform of the EU Pharmaceutical Legislation

Proposal For a Regulation of the European Parliament and of the Council Laying Down Union Procedures for the Authorization and Supervision of Medicinal Products for Human Use And Establishing Rules Governing The European Medicines Agency, Amending Regulat

. Regulation, 26 April 2023.
10. Barton, C. 

EMA Overhauls the Medicine Legislative and Regulatory Framework

Executive Steering Group on Shortages and Safety of Medicinal Products

Cheryl Barton is director at PharmaVision, Pharmavision.co.uk.

When referring to this article, please cite it as Barton, C. Phasing Out COVID-19 Regulatory Flexibilities. 

What impact will EMA’s decision to phase out COVID-19 regulatory flexibilities have on the pharma industry?

Phasing Out COVID-19 Regulatory Flexibilities

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

US Capital Building. | Image Credit: © W.Scott McGill - © W.Scott McGill - stock.adobe.com

As the federal government began to roll out the rules and procedures for negotiating prices of drugs reimbursed by Medicare Part D plans, biopharma companies launched an attack on the legality of the controversial program. Merck took the lead in filing a detailed lawsuit on June 6, 2023 in the Washington, D.C. federal district court, claiming that the negotiation process established by the Inflation Reduction Act (IRA) violates the constitutional rights of manufacturers (1).

Merck and Bristol Myers Squibb (BMS), which filed a similar lawsuit a few days later in New Jersey, charged that the Medicare price setting program would involve a “taking” of private property for public use without just compensation, in violation of the Fifth Amendment to the US Constitution (2). In addition, these companies claimed that the IRA also is unconstitutional under the First Amendment right to free speech because the process would coerce a manufacturer to sign an agreement it opposes: any company that wants to walk away from a price negotiation deal it doesn’t agree with would have to pay an onerous fine for doing so and thus is denied free speech. Both manufacturers have much to lose under the new pricing program, as lead targets for the scheme include Merck’s Januvia and Keytruda and BMS’ Eliquis and Opdivo, which would undermine company efforts to test and reformulate these therapies for new life-saving and profitable uses.

Similar to the Merck and BMS suits and to subsequent filings by Johnson & Johnson and Astellas Pharma, the US Chamber of Commerce filed a complaint in Ohio also charging that the price negotiation program violates the manufacturers’ constitutional rights. It additionally claims that Congress lacks the power to levy the specified excise tax for noncompliance because that would “compel” commerce (3).

Next up, on June 21, 2023, the Pharmaceutical Research and Manufacturers of America (PhRMA) joined a lawsuit filed by National Infusion Center Association (NICA) and the Global Colon Cancer Association (GCCA) challenging the constitutionality of the price negotiation provisions in the IRA (4). The plaintiffs take issue with the IRA’s excise tax—the provision that sets an 18% fine or more on a drug’s annual revenues for refusing to comply with the negotiated rate. Such a penalty, they claim, is an “excessive fine” and violates the constitution because there is no provision for judicial review of the many decisions involved in determining negotiated prices under the program. The plaintiffs also argue that the new law breaches due process by denying public input on the how the program will be implemented.

Beyond the specific legal issues raised in these lawsuits, which ultimately may end up before the Supreme Court, biopharma companies continue to claim that the administration’s price negotiation scheme will discourage investment in more risky research and development programs for new cures, particularly for rare diseases. Although the program exempts orphan drugs from negotiations, manufacturers note that this applies only to the first approved indication, and not to additional uses of the therapy. That provision is expected to undermine manufacturers’ plans to test additional uses for therapies hit by negotiated prices, cutting off industry’s main strategy for discovering and developing new treatments for cancer and rare diseases.

The Centers for Medicare and Medicaid Services (CMS) meanwhile is working to implement the drug price negotiation program, as mapped out in a final guidance published June 30, 2023 (5). That document made some changes from its initial memorandum issued on March 15, 2023, responding partially to the industry lawsuits challenging CMS’ planned process for reaching agreement on negotiated prices by 2026 (6).

The documents outline what information CMS will require from manufacturers in order to select the first 10 drugs for negotiations by Sept. 1, 2023. The agency then will propose “maximum fair prices” in February 2024 and final prices by August 2024, which would become effective Jan. 1, 2026.The June advisory allows for more public discussion of the negotiation process and provides leeway for manufacturers to disclose proposed prices if they choose to do so.

The bottom line will be whether Medicare price negotiations actually reduce program outlays for drugs, as promised by the Biden administration alongside critics of high drug prices. Congressional approval of the program represented an unprecedented defeat for the pharmaceutical industry’s long-time efforts to block government price control initiatives. Pharma companies claim that they have long tried to facilitate patient access to needed medicines, but through individual discounts and other strategies that maintain market share. Industry also points to health insurers and pharmacy benefit managers for thwarting these efforts and limiting opportunities to reduce patient outlays for medicines. The legal challenges are only just beginning, and much can happen in Washington between now and 2026.

Wilson, M. R. Merck Sues HHS Over Drug Negotiation, Claims Program ‘tantamount to extortion’. 

BMS. Impact of the Inflation Reduction Act on Innovative Medicines for Patients. 

Stempel, J. US Chamber of Commerce Sues Over Government’s Drug Pricing Power. Reuters.com. June 9, 2023.

PhRMA, NICA, GCCA, PhRMA Litigation Asserts Price Setting
Provisions in the Inflation Reduction Act are Unconstitutional. Press
Release. June 21, 2023.

Medicare Drug Price Negotiation Program: Revised Guidance, Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year 2026

edicare Drug Price Negotiation Program: Initial Memorandum, Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year 2026, and Solicitation of Comments

Jill Wechsler is Washington reporter for 

When referring to this article, please cite it as Wechsler, J. Industry Challenges Medicare Price Negotiation Scheme. 

Manufacturer lawsuits prompt CMS to [slightly] modify pricing plan.

Industry Challenges Medicare Price Negotiation Scheme

Chris Spivey is director of Industry Relations and Strategic Partnership, MJH Life Sciences.

The term microbiome may have first been used in an agriculture paper (1), but widespread traction was sparse until Francis Collins (then head of the National Human Genome Research Institute) talking through upcoming funding limits for simply sequencing yet another organism, with Broad Institute head, Eric Lander, had a true eureka moment, to seize upon sequencing the human microbiome—skin, gut, hair, and so forth, for multiple funding projects going forward. Suddenly all things microbiome became in vogue. However, as recently as February 2020, scientific papers were still proposing vague notions that, “The mechanisms by which microbiomes impact on cancers can yield new diagnostics and treatments, but much remains unknown” (2). What had seemed administrative legerdemain at that time of Collins eureka moment is, in 2023, absolutely a therapeutic window to drill down on. The tumor microenvironment as therapeutic approach has come of age, and the tool of the hour is messenger RNA (mRNA).

Acknowledging that bacteria and fungi form complex colonies with solid tumors, an approach to unravel this microbiome community was developed with mRNA molecules encoded to produce a toxin lethal to cohabitating bacteria. In this experiment, pseudomonas exotoxin A domain III was packaged into lipid nanoparticles and injected into the tumor bed. “We hypothesized that encoding the active domain only, without the binding and translocation domains of the original toxin, will allow potent intracellular effect upon mRNA translation, while reducing the risk of side-off effects in case of toxin release from target cells,” related professor Dan Peer, co-lead author of the study (3). Unlike chemotherapy where resistance gathers pace during extended exposure, this approach is easily amenable to simply switching to a different natural toxin. The study goes on to describe that most of the lipid nanoparticles reached cancer cells, destroying 44–60% of them.

While the history of drug discovery science is replete with false dawns, it is encouraging to see mRNA make an alliance with deeper understanding of the mechanics of the tumor microbiome. mRNA may be a modality whose chief advances are yet to come.

2. Xavier, J.; Young, V.; Skufca, J., et al. The Cancer Microbiome: Distinguishing Direct and Indirect Effects Requires a Systemic View. 

March 6(3), doi: 10.1016/j.trecan.2020.01.004.

3. Granot-Matok, Y.; Ezra, A.; Peer, D.; et al. Lipid Nanoparticles-loaded with Toxin mRNA Represents a New Strategy for the Treatment of Solid Tumors. 

When referring to this article, please cite it as Spivey, C. New Magic from mRNA. 

mRNA may be a modality whose chief advances are yet to come.

New Magic from mRNA

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

Q: I work for a virtual company that outsources our manufacturing. We recently made a regulatory filing, and I wonder what information we need to share with our contract manufacturing organization (CMO)?

A: This is an easy question. Share everything you can. Whether you filed an investigational new drug application, a new drug application, an abbreviated new drug application, a biologics license application, or a marketing authorization application, the more information you share with your contract provider(s) the smoother the approval process will be for your organization. Because you are a virtual company, your approval inspections will most likely be at your designated manufacturing facility. If you are using a different facility to test your product, the contract testing laboratory also needs to have critical information to provide the best service because they might also be audited. So, in my opinion, the contract provider(s) need to know as much as the applicant.

In today’s regulatory environment, it is important for organizations to know the regulations with the same depth of knowledge and understanding as regulators. If an organization happens to be a contract manufacturer, it might also find itself in the position of providing that in-depth regulatory expertise to customers. In either case, the contract manufacturer and its customers must be able to work with each other and within the regulatory requirements to assure that the product manufactured and released for patients is of the highest quality. The partnership between the contract provider and contract giver must reflect the requirements and time commitments as defined in the regulations. The most efficient way to establish a transparent relationship where you have the freedom to share the necessary information is to establish a robust quality agreement with your contract provider(s). If you are using a contract manufacturing organization and a different contract testing organization, it is important for you to have quality agreements with both organizations. It is ideal if you can encourage your two contract providers to enter in a quality agreement with respect to your product filing.

Because you are using contract providers, complaints are an area where the more information that is shared between all parties, the sooner a resolution to the complaint investigation can be achieved. Another area where it is necessary for all parties to have access to critical information contained in your filing is investigations for out-of-specification (OOS) results. Whether you are using multiple contract organizations or just one, those organizations should have the information needed to perform a thorough investigation into complaints or the OOSs. The complaint standard operating procedure (SOP) and the quality agreements should address the turnaround requirements needed to investigate complaints associated with adverse or serious unexpected adverse events. For these complaints, the turnaround time must be able to accommodate tighter regulatory requirements. The license holder (i.e., the client) is required to submit a Field Alert within three working days after becoming aware of a reported problem either through a complaint or internal testing. In these cases, the complaint must be investigated quickly by the contract manufacturer and/or the contract test laboratory. The turnaround time for these types of investigations must be more expeditious than the timelines for handling routine investigations. OOS reports also require an expedited timeline for communicating confirmed results to the client because of the potential impact to product already distributed for use. When there are agreements in place that allow the sharing of information that can potentially be used for resolving investigation and ensuring they are completed in a timely manner, the stronger your compliance posture will be when it comes time for your pre-approval inspection.

In today’s environment, all parties must take responsibility for product quality and regulatory compliance through clear delineation and communication of responsibilities through quality agreements and internal SOPs.

Susan J. Schniepp is distinguished fellow with Regulatory Compliance Associates.

When referring to this article, please cite it as Schniepp, S.J. Sharing Critical Information for the Best Outcome. 

The more information shared, the smoother the approval process, says 
Susan J. Schniepp, distinguished fellow with Regulatory Compliance Associates. 

Sharing Critical Information for the Best Outcome

Mike Hennessy Jr. is the Chairman and CEO of 

In June 2021, the Biden–Harris administration announced a task force to address “short term supply chain discontinuities” (1). This included strengthening Executive Order 13944, a list of essential medicines, medical countermeasures, and critical inputs (2). A report published in May 2022 highlights fundamental pillars one would expect (3).

A proposed bill by US Senator Gary Peters (MI), Chairman of the Homeland Security and Governmental Affairs Committee, building off several reports he released in the past few years, proposes to assess national security vulnerabilities in the pharmaceutical supply chain by the Mapping America’s Pharmaceutical Supply (MAPS) Act. This database will include key information about critical drugs such as the country of origin and quantity so supply chain weaknesses can be identified (4). While this might seem duplicative of other database systems such as North American Industry Classification System codes, it can be seen as part of a macro trend for government, to take further action in an already highly regulated industry. The Inflation Reduction Act (IRA) and the National Biotechnology and Biomanufacturing Initiative are cut from the same cloth.

Rumors have swirled about an under-the-radar White House initiative to gather pharmaceutical supply feedback to present potentially radical options. On this initiative, but specifically commenting on generics, Elisabeth Reynolds, a Massachusetts Institute of Technology lecturer and former special assistant to Biden for manufacturing and economic development at the National Economic Council, said, “There’s a lot of resistance in the industry to more transparency or anything that requires more cost in this low-margin business. We have to find ways to provide incentives to invest in quality, or put in place requirements to make them responsible for quality” (5).

Tom Kraus, VP government relations for the American society of health-system pharmacists, strongly supports MAPS, saying, “By requiring HHS to coordinate with other agencies and the private sector to map the pharmaceutical supply chain, threats to the US pharmaceutical supply chain can be identified and addressed before they place patients at risk” (5).

1. White House. FACT SHEET: Biden-Harris Administration Announces Supply Chain Disruptions Task Force to Address Short-Term Supply Chain Discontinuities. 

2. FDA. Reports, Executive Order 13944 List of Essential Medicines, Medical Countermeasures, and Critical Inputs. August 2020.

3. The Advanced Regenerative Manufacturing Institute (ARMI). 

Essential Medicines Supply Chain and Manufacturing Resilience Assessment

. BioFabUSA Roadmap Reports, Special Reports.

4. Senator Gary Peters Office, Peters Introduces Bipartisan Bill to Assess National Security Vulnerabilities in the Pharmaceutical Supply Chain. Press Release. July 20, 2023.

5. Griffin, R.; Edney, A.; Swetlitz, I. Secret White House Team Tackles Drug Shortages, Quality Woes. 

Mike Hennessy Jr. is the President and CEO of 

When referring to this article, please cite it as Hennessy, M. 
Supply Chain Securities. 

Mapping America’s Pharmaceutical Supply (MAPS) Act aims to establish a database including key information about critical drugs so supply chain weaknesses can be identified.

Supply Chain Securities

Customized for shear-sensitive applications with low to medium viscosity, the ROSS Model CDA-200 features a two-wing anchor agitator and two medium-speed agitators, each fit with five rows of three-blade pitched turbines. The mixer was supplied with two portable stainless-steel mixing vessels and transport covers for semi-continuous operation, a four-gallon charging hopper for introducing ingredients to the batch, and a thermoprobe for accurate temperature readings.

All three agitators are driven independently by explosion-proof inverter-duty motors. The two-wing anchor includes Teflon scrapers that contact the jacketed sidewall and bottom surfaces. Double FlexiLip seals and silicone O-rings enable vacuum operation up to 29.5 Hg for creating air-free pastes, slurries, gels, and suspensions.

Designed for heavy-duty use, the ROSS line of Multi Shaft Mixers standardizes on precision bearings with large bearing spans that reduce agitator shaft deflection and vibration, contributing to the quality and longevity of these machines. With no bearings and seals in the product zone, ROSS Multi-Shaft Mixers are designed to offer better protection against contamination compared to other designs with bottom-entering agitators

The ROSS Model CDA-200 is fitted with multiple agitators for semi-continuous operation. 

ROSS Multi-Agitator Low-to-Medium Viscosity Mixer

Sphere Fluidics’ Cyto-Mine is an automated cell line platform that integrates single cell screening, sorting, dispensing, imaging, and clone verification into one solution. Intended for use in various research areas, including antibody discovery, cell-line development, cell engineering, and synthetic biology, the device uses a unique microfluidic picodroplet technology that is designed to enable screening of up to 40 million cells over the course of several hours.

Recent software updates to the Cyto-Mine have been made to ensure compliance with current good manufacturing practice regulations. These updates include 21 

 Part 11, FDA’s regulation for electronic documentation and electronic signatures, and a full installation qualification/operation qualification package, which is intended to support quick and easy equipment qualification.

Sphere Fluidics’ Cyto-Mine is an automated cell line platform that is designed to enable screening of up to 40 million cells over the course of several hours. 

Versatile Cell Line Platform

transcription (IVT) messenger RNA (mRNA) synthesis service is designed to offer a comprehensive solution for researchers seeking high-quality, customizable mRNA synthesis with fast turnaround times. The synthesis service is intended for use in molecular biology, drug discovery, vaccine development, and gene therapy, among other fields.

The IVT mRNA synthesis service is designed to handle various applications and includes customizable mRNA synthesis capabilities to meet specific research needs. Researchers can customize mRNA transcripts in various ways, including modifying the sequence, length, and purity of the mRNA.

Eurofins Genomics Blue Heron IVT mRNA synthesis service is designed to provide researchers a customizable solution. 

Featured Content

Behind the Headlines Episode 27

Ask the Expert

Drug Digest September 2025

Enhancing Bioanalysis and Drug Development with Advanced Tools and Technologies

Top Trends Reshaping Pharma R&D