Digital Transformation in Pharma Manufacturing

Patent Cliff Deals, Tariff Pressures, and the In Vivo Cell Therapy Bet

Behind the Headlines, Episode 23

ICH Q12 and Post-Approval Changes

Speed, Flexibility Top Large-Molecule Manufacturing Trends

Drug Digest July 2025

Key Insights from Industry Survey Results

Bio/Pharma's Tariff Response

Science laboratory test tubes, laboratory equipment | Image Credit: © BillionPhotos.com - © BillionPhotos.com - stock.adobe.com

Integrated Biosciences, a biotechnology company that uses synthetic biology and machine learning to develop next-generation therapeutics for age-related diseases, announced on May 28, 2024, that it is collaborating with Illumina Ventures Labs to create novel therapeutics targeting the transcriptome. Integrated Biosciences will integrate the company’s drug discovery engine with Illumina sequencing.

Integrated Biosciences, which is developing a portfolio of preclinical-stage assets to treat multiple age-related diseases, stated in a press release that the partnership “will generate additional therapeutic assets and new discovery platforms that hold the promise of reshaping drug discovery” (1). The partnership will include monetary and scientific support and allow Integrated Biosciences to discover and design new classes of small-molecule therapeutics that shape the transcriptomes and methylomes of cell populations. The company plans for these drug candidates to be applicable to diseases where cell state and identity are important, including diseases related to aging and development.

“All drugs act by modifying cellular components, and nucleic acids are particularly important. This partnership is a nexus to using small molecules to systematically target RNA expression and DNA modifications across cell types, such that we can control exactly how cells behave,” said Felix Wong, PhD, co-founder of Integrated Biosciences, in the press release (1). “We will generate unprecedented large-scale datasets that provide maps of cell states and how to alter them, charting the course for definitive cures for age-related diseases.”

“Illumina Ventures supports innovative companies that are pursuing breakthrough science, and our partnership with Integrated Biosciences, through our Illumina Ventures Labs, represents an investment in the intersection of healthcare, genomics, and sequencing,” said Ron Mazumder, PhD, partner at Illumina Ventures, in the release. “Integrated Biosciences is an outlier early stage company that has already pioneered breakthroughs in drug discovery. Illumina Ventures is convinced that, with our unique support and resources, Integrated Biosciences will unlock novel therapeutic candidates and modalities that bring next-generation sequencing to the forefront of drug discovery.”

In December 2023, Integrated Biosciences announced a new class of small-molecule antibiotics discovered leveraging an artificial intelligence (AI)-powered platform (2). Researchers at the Massachusetts Institute of Technology (MIT), the Broad Institute of MIT and Harvard, the Wyss Institute for Biologically Inspired Engineering, and the Leibniz Institute of Polymer Research in Dresden, Germany, collaborated on the study, which screened more than 12 million candidate compounds.

“This discovery of a new class of antibiotics is a breakthrough result showing that artificial intelligence and explainable deep learning are uniquely capable of catalyzing drug discovery,” said Wong (2). “Our work makes publicly available several high-powered models to accurately predict both antibiotic activity and toxicity. Importantly, this is one of the first demonstrations that deep learning models can explain what they are predicting, with immediate and far-reaching implications to how drug discovery is done and how efficiently we can find new drugs using AI.”

“An important implication of this study is that deep learning models in drug discovery can, and in many cases should, be made explainable. While AI continues to make an impact, it is also limited by the many black box models that are commonly used and obfuscate the underlying decision-making process. By opening up these black boxes, we aim to create more generalizable insights that may be more useful in accelerating the use and development of next-generation approaches to drug discovery,” said Satotaka Omori, PhD, founding member and Head of Aging Biology at Integrated Biosciences (2).

Integrated Biosciences. Integrated Biosciences Collaborate with Illumina Ventures Labs to Design Novel Therapeutics Targeting the Transcriptome. Press Release. May 28, 2024.

Integrated Biosciences. Integrated Biosciences Announces Nature Publication Identifying New Class of Antibiotics Discovered Via Company’s AI-Powered Platform. Press Release. 

Articles

The partnership will create therapeutic assets and new discovery platforms and potentially reshape drug discovery.

Integrated Biosciences Collaborates with Illumina Ventures Labs Collaborate on Novel Therapeutics

Alan M. Mancini, RPh, is a pharmaceutical scientist.

Nishant B. Thakar, RPh, PharmD is assistant professor Clinical Sciences, Roosevelt University College of Science, Health, and Pharmacy.

Varanya Chaiyaperm, RPh, PharmD is clinical assistant professor, University of Illinois College of Pharmacy.

Pharmacist pouring white powdered chemical | Image Credit: @Kzenon- stock.adobe.com

Mathematic calculations are a critical activity in pharmaceutical compounding. All compounded preparations will require calculations at some time during their lifecycle. Types of calculations are many and varied—basic math, drug concentration, dose adjustments, batch size changes, stability testing, and many others—all of which require human performance.

Pharmaceutical Compounding Calculations in a Workplace Environment

This discussion describes the following series of activities to execute calculations for preparation of compounded dosage forms:

Stage 1 equation design. Work prior to actual calculations; integrating information, resolving inconsistencies, equation set-up, and initiating documentation.

Stage 2 numeric operations. Equation execution, result evaluation, and completing documentation.

Stage 3 independent review. Verification of information, calculations, and documentation

Management responsibilities. Key activities, personnel, priorities, and workplace culture.

Activities described address performance in the workplace environment. These may be performed by an individual person in a 503A pharmacy or by multiple people in 503B outsourcing facilities, pharma industry, and other settings.

Content in this discussion reflects academic teaching, personal experiences in multiple organizations, and published accounts of adverse events. Textbooks (1–9) and academic education provide theory. Application in the workplace is much different—actual drugs, sick patients, medication orders in multiple formats, time pressures, information discrepancies, and workplace interruptions and distractions—all of which have potential for errors. Calculations errors may have significant ramifications: patients receive toxic overdoses or ineffective underdoses; healthcare practitioners suffer personal remorse (10); management is embarrassed (11); and organizations face legal consequences (12).

Additional discussion on this topic including case studies is available under the same title at PharmTech.com (13). The calculations process in this discussion is focused on specific calculations activities separate from a comprehensive dosage form compounding process.

Stage 1, equation design, comprises activities in advance of actual calculations (i.e., thinking, planning, verifying information, estimating, setting up equations, and initiating documentation). Stage 1 emphasizes proactive thinking about the calculations to be performed.

Calculations objective. Calculations for preparation of a compounded dosage form must be clearly identified. Three questions are fundamental:

What is to be calculated? What is the desired final outcome of the calculations? Where are we going?

What information is known? What is given, what is relevant, what is not relevant? What is the medication order telling us? Excess information sometimes confuses identifying the calculation objective.

What is unknown? What don’t we know, what is missing, what is questionable and needs confirmation, and how do we get this information?

This is a tried-and-true process in problem solving, troubleshooting, investigations, and related activities. It forces thorough and logical thinking. A plan to accomplish the calculations objective is needed. One cannot begin to set up equations without initiating logical and common-sense thought. Especially relevant in these activities are the associated units of measure for all values.

Compile information. Concurrent with identification of the calculations objective is the collection of relevant information. Missing information must be obtained; questionable information must be investigated. Pertinent information must be written; do not make assumptions or depend on memory. Correctly executed calculations using erroneous information may be fatal (14). Verbal information must be repeated and confirmed in writing. Misunderstanding due to language dialects may contribute to errors.

Paul L. Pluta, RPh, PhD, is a pharmaceutical scientist. Alan M. Mancini, RPh, is a pharmaceutical scientist. Nishant B. Thakar, RPh, PharmD is assistant professor Clinical Sciences, Roosevelt University College of Science, Health, and Pharmacy. Varanya Chaiyaperm, RPh, PharmD is clinical assistant professor, University of Illinois College of Pharmacy.

When referring to this article, please cite it as Pluta, P.L.; Mancini, A.M.; Takar, N.B.; Chaiyaperm, V. Pharmaceutical Compounding Calculations in a Workplace Environment. 

Pharmaceutical Technology Trends in Manufacturing

An ordered process describing calculations activities for compounded dosage forms is described.

Joe Payne, Scorpius BioManufacturing, explains why CDMOs are essential to biopharma drug development.

A Different CDMO Experience: Q&A With Scorpius’ President & COO Joe Payne

Learn about Scorpius’ president and COO, Joe Payne, as a thought leader who is also approachable, energetic, and in-tune with client needs.

Learn about Scorpius’ competitive advantages in biomanufacturing of small-volume, early-stage large molecules.

Learn what it takes to produce an end product that can be shared with both prospective clients and prospective employees.

Videos

Joe Payne, Scorpius BioManufacturing, comments on the unique needs of today's biopharmaceutical companies looking to develop and manufacture small-volume, early-stage large molecules.

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

 podcast, Felicity Thomas, European/Senior Editor, chats with Alexander Natz, Secretary-General of EUCOPE, about the European Health Data Space (EHDS), which was formally adopted by the European Parliament in April 2024. The EHDS aims to improve individual’s the access to and control of their own health data and also to allow for the secondary use of health data in research, innovation, policy-making, and regulatory activities.

 is Secretary-General of the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE). As Secretary-General, Alex advises innovative pharmaceutical and biotech companies, including start-ups, in regulatory and pricing and reimbursement matters from the European Union law and German law perspective. From 2008 to 2013, he was Head of the Brussels Office of Bundesverband der Pharmazeutischen Industrie e.V. (BPI). Before, he worked as a lawyer at Sträter Law Firm in Germany with a special focus on managed entry agreements and licensing of pharmaceuticals. Alex has also worked in the field of competition law with the European Commission and in the pharmaceutical industry. As a research assistant at Duke University (USA) he has dealt with international pharmaceutical law.

 presents the Drug Solutions podcast, where the editors will chat with industry experts from across the pharmaceutical and biopharmaceutical supply chain. Join us as experts share insights into your biggest questions—from the technologies, to strategies, to regulations related to the development and manufacture of drug products.

Podcasts

In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.

Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail

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

Mary (Nora) Disis, MD, University of Washington

Pablo Guasp, PhD, Memorial Sloan Kettering Cancer Center (MSK)

American Society of Gene and Cell Therapy’s (ASGCT’s) 27th Annual Meeting

 in Baltimore, Md., which occurred May 7–11, 2024, Pablo Guasp, PhD, MSK asked himself the question, “What can we use to teach the immune system how to recognize cancer cells?” Replying, “… the neoantigen that arise from the accumulation of mutations in cancer cells can be good candidates … while a limitation is that neoantigens usually impose a restriction towards personalized treatments; therefore, we need a delivery platform that allows for modularity where we can include and exclude neoantigens based on the mutations of each individual patient. Also, we need a platform that allows us to do this in a timely manner, so we can treat patients soon after they are diagnosed. We believe that nucleic acid [developments] have been a breakthrough in this field, and in particular mRNA [messenger RNA] is showing very promising results”. Guasp then considered which patients benefit the most from this approach, stating, “If we look at vaccines against infectious agents we see that vaccines are always given in a prophylactic setting before the patient develop[s] the disease. But, paradoxically, cancer vaccines historically have been tested in patients with advanced and metastatic disease, and we think that this may not be the best scenario. We think that cancer vaccines may work best in patient with minimal disease, such as patients that had their tumors surgically resected” he averred. 

MSK partnered with BioNTech and Genentech to launch the first clinical trial of personalized mRNA cancer vaccines in pancreatic cancer. The results of this trial were published in 2023 (1). In only nine weeks, patients were receiving their own individualized cancer vaccine. This happened in such a timely manner, “because of a huge collaborative effort between all the members involved in the teams, but also because mRNA allows for this quick modularity, and this speed that I was mentioning before,” Guasp said.

During those nine weeks, the patient received a single dose of anti programmed cell death ligand 1 immunotherapy with atezolizumab and then received eight priming doses of the vaccine, followed by a standard-of-care chemotherapy and a single vaccine boost dose. “We identified specific responses elicited by the vaccine in half of the patients that receive[d] the vaccine. Not only that, but response to the vaccine correlate[s] with a delay recurrence time. … We know that this is a small clinical trial with a small number of patients, but the results are promising” Guasp added.

1. Rojas, L. A.; Sethna, Z.; Soares, K. C.; et al. Personalized RNA Neoantigen Vaccines Stimulate T Cells in Pancreatic Cancer. 

, 144–150. DOI: 10.1038/s41586-023-06063-y

In an ASGCT Panel on nucleic acid- and cell-based vaccines in oncology, work on a personalized mRNA vaccine was highlighted.

Highlighting Personalized mRNA-Based Vaccines for Pancreatic Cancer (ASGCT 2024)

Feliza Mirasol is the science editor for 

AGC Biologics announced on May 22, 2024 that is has formed a new strategic partnership with BioConnection, a contract manufacturing organization specializing in aseptic filling of vials and syringes for clinical and commercial production. The companies plan to provide end-to-end biopharmaceutical development and manufacturing capabilities for drug substance and drug product.

The goal of this partnership is to offer full-service clinical-stage development and manufacturing to shorten timelines and bring biopharmaceuticals to market more efficiently, a “gene to vial” value chain service that comprises a single contract and project management team for the project lifecycle, according to a company press release. The partnership addresses the industry’s ongoing needs in light of the proposed 

 proposed by US legislators in January 2024, which states, “Specifically, the bill prohibits executive agencies from 1) procuring or obtaining any biotechnology equipment or service produced or provided by a biotechnology company of concern, or 2) entering into a contract or extending or renewing a contract that uses such equipment or service or that will require the direct use of such equipment or services. Those agencies may not obligate or expend loan or grant funds for such purposes” (1).

“By having a combined end-to-end solution that uses facilities in Japan, the United States, and Europe, developers now have a reliable and secure supply of services for development, manufacturing (including freeze-drying) and aseptic filling for their drug product’s needs,” stated Biogen in its press release.

According to the release, AGC Biologics is well-positioned to support drug developers’ needs, especially those who may be impacted by the proposed legislation. “Developers seeking alternatives from their current outsourcing partner benefit from access to AGC Biologics’ single-use network utilizing ubiquitous bioreactor technology, enabling an easier transfer of platform processes and reduction in process changes associated with changing outsourcing partners,” the company stated in the press release.

AGC Biologics protein-biologics services comprise cell line development through to commercial-scale manufacturing, and the company’s capabilities support drug substance manufacturing from microbial- and mammalian-based systems as well as plasmid DNA and messenger RNA. BioConnection’s aseptic filling capabilities for vials and syringes offer tailored solutions for clinical and commercial production of either liquid or freeze-dried products.

“Now more than ever global pharmaceutical companies and developers need reliable facilities to produce and fill their drug products, and by combining our resources with BioConnection we are offering a new end-to-end solution for them under one contract with AGC Biologics,” said Patricio Massera, CEO of AGC Biologics, in the press release. “We believe BioConnection has a strong acumen, and this established partnership will enhance our biopharmaceutical manufacturing offering by providing drug product services for protein biologics, allowing us to create deeper relationships with developers to help get their products to patients in need.”

Alexander Willemse, CEO of BioConnection, added in the release, "We are excited to join forces with AGC Biologics to offer integrated manufacturing solutions that address the complexities of biopharmaceutical development. Together, we are well-positioned to support our clients at every stage."

The partnership aims to provide end-to-end development and manufacturing for biopharmaceutical drug substance and drug product. 

AGC Biologics Partners with BioConnection to Offer Biopharma Drug Substance and Drug Product Development and Manufacturing

On May 22, 2024, Biogen announced that it is acquiring Human Immunology Biosciences (HI-Bio), a privately-held US-based clinical-stage biotechnology company specializing in targeted therapies for severe immune-mediated diseases (IMDs). The transaction is worth potentially up to $1.8 billion, which includes a $1.15 billion upfront payment and up to $650 million in potential milestone payments. The deal is expected to close in the third quarter of 2024, subject to necessary regulatory approvals and customary closing conditions.

With the acquisition, Biogen gains felzartamab, HI-Bio’s lead asset. Felzartamab is a fully human anti-CD38 monoclonal antibody (mAb) that has been shown to selectively deplete CD38+ cells in clinical studies. This selective depletion includes plasma cells and natural killer (NK) cells. This action may allow for additional applications that improve clinical outcomes in a broad range of immune-mediated diseases, Biogen stated in a company press release.

“We believe this late-stage asset, which has demonstrated impact on key biomarkers and clinical endpoints in three renal diseases with serious unmet needs, is a strategic addition to the Biogen portfolio as we continue to augment our pipeline and build on our expertise in immunology,” said Priya Singhal, MD, head of Development at Biogen, in the press release. “We look forward to welcoming HI-Bio employees into Biogen and, together, working to advance potential therapies for patients with rare immune diseases with high unmet need.”

FDA has granted felzartamab breakthrough therapy designation and orphan drug designation for development in treating primary membranous nephropathy (PMN). The mAb has also received orphan drug designation for treating antibody-mediated rejection (AMR) in kidney transplant recipients. Felzartamab has completed Phase II studies in PMN and AMR and remains in ongoing Phase II studies in immunoglobulin A nephropathy (IgAN). HI-Bio plans to advance the mAb to Phase III studies in each indication; the company is presenting two abstracts at the 

 in Stockholm, which is occurring May 23–26, 2024. HI-Bio’s presentation includes complete Phase II data from the AMR study in kidney transplant patients and interim data from the Phase II IgAN study, according to the press release. Studies have also generated clinical data for felzartamab in the AMR, PMN, and IgAN indications.

“With its deep development and commercialization capabilities, Biogen is in a position to accelerate the development of new medicines, including felzartamab, for patients with severe immune-mediated diseases,” said Travis Murdoch, MD, chief executive officer of HI-Bio, in the release. “We are excited to combine the HI-Bio team’s expertise with Biogen’s global footprint.”

In addition to the felzartamab lead program, HI-Bio’s pipeline consists of izastobart/HIB210, an anti-C5aR1 antibody currently in a Phase I trial. This candidate has the potential for continued development in a range of complement-mediated diseases. HI-Bio also has discovery-stage mast cell programs with potential application in a range of immune-mediated diseases.

The treatment of IMDs has largely benefitted from the evolution of targeted biologic therapies. Targeted biologics have demonstrated efficacy, speed of onset, and tolerability. What’s more, research efforts have shown that clinically unrelated immune-mediated inflammatory conditions can share similar immune dysregulation. This discovery has since led to a shift in way IMDs and other inflammatory disorders are managed (1).

1. Kuek, A.; Hazleman, B. L.; Ostör A. J. Immune-Mediated Inflammatory Diseases (IMIDs) and Biologic Therapy: A Medical Revolution. 

 (978), 251–260. DOI: 10.1136/pgmj.2006.052688

With the acquisition, Biogen gains felzartamab, HI-Bio's lead investigational mAb candidate being developed for the treatment of a range of immune-mediated diseases. 

Biogen to Acquire HI-Bio in Deal Worth Potentially Up to $1.8 Billion

Merck KGaA, Darmstadt, Germany, will acquire Mirus Bio, a US-based life science company, in a $600 million deal, or approximately €550 million, according to a May 22, 2024 announcement. Pending regulatory clearance and other customary closing conditions, the transaction is expected to close in the third quarter of 2024.

The acquisition will strengthen Merck KGaA’s offerings in the viral vector manufacturing sector because Mirus Bio specializes in the development and commercialization of transfection reagents. Transfection reagents are used to introduce genetic material into cells and play a key role in producing viral vectors for use in cell and gene therapies (CGTs), according to a company press release.

“This strategic acquisition is a further building block for accelerating growth in the break-through technologies of the future. As a leader in the production of viral vectors, our goal is to make the significant potential of cell and gene therapy available for patients worldwide,” said Belén Garijo, chair of the executive board and CEO of Merck KGaA, Darmstadt, Germany, in the company press release.

The Mirus Bio acquisition represents an important step towards Merck KGaA’s goal to offer solutions for every step of viral vector manufacturing for the advancement of CGTs, from preclinical through commercial production, the company stated in the press release. Merck KGaA’s services cover a variety of viral vector types, including adeno-associated virus, lentivirus, and adenovirus. Additionally, the company offers both contract testing services and a range of comprehensive contract development and manufacturing services for viral vector manufacturing.

According to the company, the global market for process products for novel modalities such as CGTs, antibody-drug conjugates, and messenger RNA (mRNA) is expected to grow by approximately 20% per year over the mid-term (i.e., within 10 years). The overall number of CGTs in development has doubled since 2019, and more candidates are advancing to the commercial stage, for example.

“Novel modalities, such as viral vector-based cell and gene therapies, hold immense promise to improve the lives of patients. Combining Mirus Bio's leading technology with our bioprocessing expertise and portfolio allows us to provide solutions for almost every step of viral vector development and manufacturing,” said Matthias Heinzel, member of the executive board of Merck KGaA, Darmstadt, Germany, and CEO Life Science, in the press release. “With our integrated offering along the viral vector value chain, we are now well-positioned to support our customers in this fast-growing market to positively impact the lives and health of patients worldwide.”

Viral vectors are a key component in the production of these therapies. Thus, to support that growth, Merck KGaA opened its second Carlsbad, Calif.-based viral vector contract development manufacturing facility in 2021 (1). The company invested €100 million (US$108 million) in the site, which more than doubled the company’s capacity for supporting large-scale commercial and industrial manufacturing for viral vector-based gene therapies.

In addition to its second viral vector manufacturing facility, Merck KGaA also continues to invest in R&D that will enable new therapeutics to be brought to market. In April 2024, the company announced it was investing more than €300 million (US$325 million) to establish a new life science research center at its global headquarters in Darmstadt (2). The investment will harness research on key technologies for the manufacture of antibodies, novel modalities such as CGTs and mRNA applications, and additional products required for biotechnological production.

“We have been driving innovation in nucleic acid delivery for two decades,” said Dale Gordon, CEO of Mirus Bio, in the press release. “The broad portfolio, scale, and global reach of Merck KGaA, Darmstadt, Germany, combined with our leading transfection reagents, will help take our business to even greater heights and allow us to serve more customers, and ultimately patients, worldwide.”

1. Merck KGaA. Merck KGaA, Darmstadt, Germany, Completes New Viral Vector Contract Development Manufacturing Facility for Gene Therapy. Press Release, Oct. 12, 2021.
2. Merck KGaA. Merck KGaA, Darmstadt, Germany, Invests More Than € 300 Million in New Life Science Research Center. Press Release, April 25, 2024.

With this acquisition, Merck KGaA will have the capability to offer integrated services for viral vector manufacturing.

Merck KGaA Announces $600 Million Deal to Acquire Mirus Bio

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Hospira, a Pfizer company, announced on May 21, 2024 that it was voluntarily recalling the lots listed in the table below of Buprenorphine Hydrochloride Injection Carpuject Units and Labetalol Hydrochloride Injection, USP Carpuject Units because of incomplete crimp seals. The company also received a customer complaint of a leaking unit.

The recalled lots were distributed nationwide to wholesalers/hospitals in the United States from September 2023 through April 2024. The National Drug Code (NDC), lot number, expiration date, and configuration details for the recalled lots are as follows:

Buprenorphine Hydrochloride Injection–CIII, Carpuject Single-dose Cartridge/Tube Unit with Luer Lock. NDC: Carton 0409-2012-32, Cartridge 0409-2012-03; lot number HJ3965, expiration date 2024/09; lot number HJ8546, expiration date 2024/10. Both have a concentration of 0.3 mg base/mL and are 10 cartridge units/carton.

Labetalol Hydrochloride Injection, USP Carpuject Single-dose Cartridge Unit with Luer Lock. NDC: Bundle 0409-2339-34, Carton/Cartridge 0409-2339-24; lot number HJ7566, expiration date 2025/05; lot number HN8747, expiration 2025/09; HN8749 expiration date 2025/09. Both have a concentration of 20 mg/4 mL (5 mg/mL) and are 10 carton/ cartridge units/bundle. 

While Pfizer has not received any related reports of adverse events, if an impacted product is administered, there is an increased risk for lack of efficacy and systemic infection that might require additional treatment, according to the company. Adverse events may be reported to FDA through the agency’s MedWatch program.

“Pfizer places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Pfizer has notified direct consignees by letter to arrange for the return of any recalled product,” the company stated in a press release (1).

Buprenorphine HCl Injection, a clear, sterile, injectable agonist-antagonist analgesic intended for intravenous or intramuscular administration, is used to manage pain for which alternate treatments are inadequate. Labetalol HCl Injection is a treatment for controlling blood pressure in severe hypertension.

In December 2023, the company had another voluntary recall. That recall was of lots of 4.2% Sodium Bicarbonate Injection, USP ABBOJECT Glass Syringe, 5 mEq/10 mL; 8.4% Sodium Bicarbonate Injection, USP Lifeshield ABBOJECT Glass Syringe, 50 mEq/50 mL; and Atropine Sulfate Injection, USP Lifeshield ABBOJECT Glass Syringe, 1 mg/10 mL because of the presence of glass particulate matter found during product inspection (2).

“Potential complications related to injection of visible and subvisible inert particles include inflammation of a vein, granuloma, and blockage of blood vessels or life-threatening blood clot events. The frequency and severity of these adverse events could vary depending upon a variety of factors including the size and number of particles in the drug product, patient comorbidities (such as age, compromised organ function), and presence or absence of vascular anomalies,” the company stated in the release (2).

Hospira. Hospira Inc. Issues a Voluntary Nationwide Recall for Buprenorphine Hydrochloride Injection CarpujectTM Units and Labetalol Hydrochloride Injection, USP CarpujectTM Units Due to the Potential for Incomplete Crimp Seals.

Hospira. Hospira, Inc. Issues A Voluntary Nationwide Recall For 4.2% Sodium Bicarbonate Injection, 8.4% Sodium Bicarbonate Injection, and Atropine Sulfate Injection Due to the Potential Presence of Glass Particulate Matter. Press Release. 

The units are being recalled because of incomplete crimp seals and one complaint of a leaking unit.

Hospira Recalls Buprenorphine Hydrochloride Injection Carpuject Units and Labetalol Hydrochloride Injection, USP Carpuject Units 

Bristol Myers Squibb (BMS) announced on May 22, 2024 that it is creating a 10-year plan—ASPIRE (Accessibility, Sustainability, Patient-centric, Impact, Responsibility and Equity)—to expand access to its therapies to more than 200,000 patients in low- and middle-income countries (LIMCs) by 2033. The ASPIRE plan will include strategies and the development of access plans to increase affordability and availability of BMS’ medicines in LMICs to ensure 100% of the company’s marketed products are supported by access plans. 

BMS has introduced local brands of their drugs, with the company filing 11 local brands in 2023; five have received regulatory approvals. “BMS local brands are making an impact in countries [such as] Thailand, which has the highest prevalence of beta thalassemia, by providing treatment options [such as] Rojusna to help combat this widespread disease,” the company stated in a press release (1).

Part of the ASPIRE plan is for BMS to collaborate with the Access to Oncology Medicines (ATOM) Coalition to bring its cancer treatment, Opdivo (nivolumab), to Pakistan, Rwanda, Zambia, and other countries. ATOM is led by the Union for International Cancer Control and includes 40 global partners to address the challenges of availability, affordability, and appropriate use of oncology medicines.

“Access to potentially life-saving innovative medicines is very limited in some parts of the world, leaving patients with few treatment options for serious diseases [such as] cancer,” said Christopher Boerner, PhD, board chair and chief executive officer, Bristol Myers Squibb, in the press release. “Bristol Myers Squibb believes patients who can benefit from our medicines should have access to them. Our ASPIRE strategy is an important step toward accelerating and expanding patient access to these much-needed treatments.”

In countries where BMS does not have a commercial presence, the company is making its medicines available through the Direct Import and the Direct-to-Institution (DTI) pathways. BMS is providing 12 medicines using a tiered pricing commensurate to more than 80 LIMCs through the Direct Import pathway. The DTI pathway, which provides safe, broad, and timelier access to BMS medicines through collaboration with local institutions, includes efforts in five LMICs in East Africa and Pakistan and West Africa in 2025. The goal is to include more than 15 LMICs by 2026.

“By investing in solutions that reduce quality-of-care gaps and strengthen health systems, BMS will help drive equitable access to innovative medicines to patients around the world, regardless of where patients live. Enabling timely access to innovative medicines in LMICs is part of BMS’ commitment to health equity globally and our Environmental, Social and Governance (ESG) strategy,” the company stated in the release.

 that it is has established an agreement with Cellares, a US-based integrated development and manufacturing organization specializing in cell therapy manufacturing, to reserve global capacity and supply for manufacturing chimeric antigen receptor T-cell therapies. The deal is valued at up to $380 million in upfront and milestone payments (2). 

Bristol Myers Squibb Announces 10-Year Strategy to Reach More Patients in Low- and Middle-Income Countries.

Bristol Myers Squibb. Bristol Myers Squibb and Cellares Announce a $380M Worldwide Capacity Reservation and Supply Agreement for the Manufacture of CAR T Cell Therapies to Bring the Promise of Cell Therapy to More Patients, Faster. Press Release. April 22, 2024.

The company is collaborating with the Access to Oncology Medicines Coalition to expand patient access to immuno-oncology therapy Opdivo.

Featured Content

Digital Transformation in Pharma Manufacturing

Behind the Headlines, Episode 23

ICH Q12 and Post-Approval Changes

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