Pharmaceutical Technology Editors

, which launches during the CPHI Frankfurt event from Nov. 1–3, 2022, there is predicted to be an expansion in the demand for contract research organizations (CROs) and contract development and research organizations (CDMOs) in the pharmaceutical space. This demand will be driven by volumes of venture capital (VC) and private equity cash reserves.

Brian Scanlan of Edgewater Capital is quoted in the report, saying, “Despite the economic and inflationary uncertainty, CRO[s] and CDMOs are likely to be the chief beneficiaries of the investment capital that has poured into biotech during the last two years—with little slowdown in growth—despite the more challenging market conditions.” Funding will support contract sector valuations and investment in CRO/CDMO infrastructure, according to Scanlan.

“Putting pandemic-related factors aside, a significant portion of the heightened demand for CRO/CDMO services has been driven by VC-backed pharma and biopharma companies. Presently, VC-funded biotechs are sitting on two to three years of cash reserves, and this will ultimately transfer through, in part, to contract services. On top of this, biotech funding that has been raised over the last couple of years … is likely to be deployed relatively soon because these closed-end investment vehicles must be used in deals within four to five years,”added Scanlan in the report.

Smaller and medium CDMOs are forecasted to see growth from new compounds entering development, the report states. CPHI says these compounds in development “are effectively already ‘queued up’ for further development as public markets swing back and funding levels resume.” Larger CDMOs are expected to benefit most from later-phase compounds.

Reshoring in supply chains is also a factor in the increase in investment, according to CPHI. “The Russian/Ukraine conflict, EU [European Union] energy concerns, and US–China tensions [are] all creating uncertainty about moving vital materials around the globe,” according to a CPHI press release.

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The CPHI Annual Report 2022 predicts cash reserves from venture capitalists and private equities will drive expansion in the demand for contract research organizations and contract development and research organizations.

Venture Capital Funding to Fuel Pharma Outsourcing

CSafe, a US-based provider of active and passive temperature-controlled shipping solutions, and BioLife Solutions, a US-based supplier of bioproduction tools and services for the cell and gene therapy (CGT) and broader biopharma markets, have formed a new partnership to provide a combined global service network to support CGT products. The partnership will focus on enhanced reliability, security, and quality, according to an Oct. 11, 2022 company press release.

BioLife expects to support 10,000–12,000 shipments of CGT starting materials and manufactured doses over the next 12 months using its evo cold chain management platform. The new partnership with CSafe will provide BioLife with expanded supply chain options for any CGT product at any stage of development, from early clinical-phase trials to global commercial scale. CSafe operates more than 50 service centers worldwide.

“CSafe is honored to partner with the team at BioLife Solutions, whose range of CGT bioproduction tools and services is peerless in the market. We are excited to merge these exceptional tools and services with our expertise in global, reliable scaled delivery,” said CSafe CEO Patrick Schafer in the press release. “CGT is hitting its stride and needs global support. We know how important these therapies are to patients everywhere, and it’s our mission at CSafe to protect every shipment.”

“We’re excited to work with a global partner with a strong history of reliability and performance and a deep dedication to innovative therapies,” said BioLife Solutions CEO Mike Rice in the release. “We have the best LN2 [liquid nitrogen] technology and [C]GMP [current good manufacturing practice] storage facilities in the market, in addition to our other world-class CGT solutions, and we are confident our collaboration with CSafe will extend our reach and result in even more reliability and real-time service for CGT partners.”

The newly formed partnership between CSafe and BioLife will expand cold chain supply chain solutions for the cell and gene therapy market.

CSafe and BioLife Solutions Partnership Will Expand Supply Chain for Cell and Gene Therapies

On Oct. 24, 2022, AstraZeneca announced that FDA has approved Imjudo (tremelimumab), a human monoclonal antibody (mAb), in combination with Imfinzi (durvalumab), also a human mAb, for treating adult patients with unresectable hepatocellular carcinoma (HCC). HCC is the most common type of liver cancer.

The approval was based on positive results from a Phase III trial (HIMALAYA), which demonstrated that patients treated with the combination of Imjudo and Imfinzi experienced a 22% reduction in the risk of death compared to sorafenib, an oral kinase inhibitor used to treat late-stage liver cancer. The results of the Phase III trial also showed evidence that the combination therapy allowed an estimated 31% of patients to live three years after administration, compared to 20% of sorafenib-treated patients, who showed the same longevity.

The novel dose and schedule of combination entails a single dose of Imjudo at 300 mg added to Imfinzi at 1500 mg, and this regimen is followed by Imfinzi every four weeks. In addition to the United States, regulatory applications for Imjudo in combination with Imfinzi are currently under review in Europe, Japan, and several other countries.

“Patients with unresectable liver cancer are in need of well-tolerated treatments that can meaningfully extend overall survival. In addition to this regimen demonstrating a favorable three-year survival rate in the HIMALAYA trial, safety data showed no increase in severe liver toxicity or bleeding risk for the combination, important factors for patients with liver cancer who also have advanced liver disease,” said Ghassan Abou-Alfa, MD, attending physician at Memorial Sloan Kettering Cancer Center and principal investigator in the HIMALAYA Phase III trial, in an AstraZeneca company press release.

“With this first regulatory approval for Imjudo, patients with unresectable liver cancer in the US now have an approved dual immunotherapy treatment regimen that harnesses the potential of CTLA-4 [cytotoxic T-lymphocyte-associated protein 4] inhibition in a unique combination with a PD-L1 [programmed cell death ligand 1] inhibitor to enhance the immune response against their cancer,” said Dave Fredrickson, executive vice-president, Oncology Business Unit, AstraZeneca, in the release.

AstraZeneca’s Imjudo (tremelimumab) was approved by FDA in combination with Imfinzi (durvalumab) for treating unresectable liver cancer.

FDA Approves AstraZeneca’s Imjudo for Combination Liver Cancer Treatment

Cambrex announced on Oct. 4, 2022 the expansion of Q1 Scientific, its stability storage business, which offers environmentally controlled stability storage services to the pharmaceutical, medical device, and life sciences industries. Its existing facility in Waterford, Ireland will have an additional 10,000 ft2 expansion, and a new 20,000 ft2 current good manufacturing practices (CGMP) facility will be opened in Belgium.

The new temperature-controlled and monitored storage facility in Belgium will be located in the Liege region. The facility will provide 35,000 temperature-controlled storage spaces. The Waterford-based Ireland facility has doubled in size over the past two years and continues to grow with this new 10,000 ft2 expansion.

“With Cambrex’s scientific expertise and scale, we are able to accelerate our growth plans and launch a second site in 2023,” said Stephen Delaney, managing director of Q1 Scientific, in a company press release. “Operating two sites will be a great benefit to our European customers, who can now expect even faster turnaround times for the return of samples. Meanwhile, we will also be able to provide greater temperature-controlled transport options in mainland Europe.”

Cambrex has expanded its stability storage business, Q1 Scientific, in Ireland and Belgium.

Cambrex Announces Stability Storage Expansions in Ireland and Belgium

According to World Health Organization’s (WHO’s) global classification system for national medical product regulatory authorities, WHO has ranked South Africa’s vaccine regulatory system at a functional level of maturity. This ranking recognizes that South Africa has a stable, well-functioning, and integrated regulatory system to ensure the quality, safety, and effectiveness of vaccines manufactured, imported, or distributed in the country.

WHO confirmed that the country has attained maturity level three (ML3), the third of four levels in WHO’s classification system. Maturity level four (ML4) is the highest.

“This achievement affirms South Africa’s trailblazing endeavor in health research. Beyond its technical aspects, this milestone carries real implications for people’s health. We cannot talk about better health care without quality medical supplies,” said Matshidiso Moeti, WHO regional director for Africa, in a press release. “This is an important new step not only for South Africa, but for the region, toward self-sufficiency in vaccines and medicines.”

“This rapid progress on vaccines regulation is a significant milestone for South Africa, the Southern African region, and the continent. It is an important win for vaccine equity, as the country is a major manufacturer of medical products, and this regulatory milestone will help maximize the impact of the mRNA [messenger RNA] vaccine technology hub,” said Tedros Adhanom Ghebreyesus, WHO director-general, in the release.

South Africa’s vaccine regulator has reached new WHO level to ensure safety, quality, and effectiveness.

WHO Ranks South Africa’s Vaccine Regulatory System at a Functional Level of Maturity

Societal CDMO, a US-based contract development and manufacturing organization (CDMO), announced on Oct. 20, 2022 that it has entered into two new contract development and manufacturing (CDMO) service agreements. Under the new agreements, the company will offer a range of analytical method, technical transfer, formulation, manufacturing, and packaging services in support of ongoing development programs for novel therapeutic candidates.

With the first contract, the services provided will go toward supporting the ongoing clinical development of a modified release, bead-filled capsule formulation of an oral biologic that is already approved in Canada and indicated for pancreatic insufficiency. The range of services under this contract will include analytical method development and validation, technical transfer combined with formulation optimization, clinical trial batch manufacturing, and primary packaging for the drug. Societal CDMO’s activities will also support a planned Phase III clinical trial as part of an ongoing clinical development program for the drug in the United States.

Under the second contract, Societal CDMO will conduct a range of activities to support the development of a novel interleukin-2 (IL-2) analog for the treatment of cancer. The company will provide services such as formulation development, analytical method transfer and verification, and good manufacturing practice (GMP) batch manufacturing as well as fill/finish. The program for this drug is currently in preclinical development.

“[O]ur support of the late clinical-stage oral biologic program has the potential to contribute to an increase in our commercial revenues and is also evidence of the strong reception that our Clinical Trial Services offerings are receiving from drug developers,” said David Enloe, CEO of Societal CDMO, in a company press release.

Under two new agreements, Societal CDMO will offer analytical, technical transfer, formulation, manufacturing, and packaging services for novel therapeutics.