Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2603

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2603
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actices, lot consistency and timely availability of raw materials. Even if we obtain marketing approval for any of our product candidates,
there is no assurance that our manufacturers will be able to manufacture the approved product to specifications acceptable to the FDA
or other comparable foreign regulatory authorities, to produce it in sufficient quantities to meet the requirements for the potential
commercial launch of the product or to meet potential future demand. Additionally, if we advance a biological candidate into IND-enabling
studies, the manufacturing processes for biological products is more complex and expensive than with small molecule products and additional
manufacturing suppliers may be needed to manufacture clinical supplies for these programs. If our manufacturers are unable to produce
sufficient quantities for clinical trials or for commercialization, our development and commercialization efforts would be impaired,
which would have an adverse effect on our business, financial condition, results of operations and growth prospects.

The
manufacture of drug products, and particularly biologics, is complex and our third-party manufacturers may encounter difficulties in
production. If any of our third-party manufacturers encounter such difficulties, our ability to provide supply of our current product
candidates or any future product candidates for clinical trials or our products for patients, if approved, could be delayed or prevented.

Manufacturing
drugs, particularly biologics, especially in large quantities, is often complex and may require the use of innovative technologies to
handle living cells. Each lot of an approved biologic must undergo thorough testing for identity, strength, quality, purity and potency.
Manufacturing biologics requires facilities specifically designed for and validated for this purpose, and sophisticated quality assurance
and quality control procedures are necessary. Slight deviations anywhere in the manufacturing process, including filling, labeling, packaging,
storage and shipping and quality control and testing, may result in lot failures, product recalls or spoilage. When changes are made
to the manufacturing process, we may be required to provide preclinical and clinical data showing the comparable identity, strength,
quality, purity or potency of the products before and after such changes. If microbial, viral or other contaminations are discovered
at the facilities of our manufacturers, such facilities may need to be closed for an extended period of time to investigate and remedy
the contamination, which could delay clinical trials and adversely harm our business.

In
addition, there are risks associated with large scale manufacturing for clinical trials or commercial scale including, among others,
cost overruns, potential problems with process scale-up, process reproducibility, stability issues, compliance with good manufacturing
practices