Biopharmaceuticals: An Overview

Biological medical products, also known as biologics, or biopharmaceuticals, are being developed at a fast pace due to the consistently increasing demand throughout the healthcare industry. According to The National Center for Biotechnology Information (NCBI), biopharmaceuticals refer to “pharmaceuticals produced in biotechnological processes using molecular biology methods”. This is opposed to the chemical synthesis process that is used in traditional pharmaceutical manufacturing.

Biotech vs Pharma

Biotechnology involves the use of technology and living organisms or other biological systems to create medicines, foods, or other products. Biotech is used for therapeutic proteins, gene therapy, and other types of medicinal products. It’s also used for other purposes, such as agricultural, environmental, and industrial. 

The pharmaceutical industry develops and produces medicines used for disease prevention and treatment, as well as prevention and treatment for other medical conditions. Standard pharmaceutical manufacturing typically uses chemical synthesis to create medicine. 

The NCBI compares the biopharmaceutical manufacturing industry to the synthetic process to outline some key differences between the two. These include “the nature of the product, the source of the active agent, bioequivalence criteria, identity, structure, manufacturing methods, composition, dosing, formulation, handling, intellectual property rights, legal regulations, and marketing”.

Biopharmaceutical Companies 

Biopharmaceutical companies have an increasingly valuable role in the treatment and prevention of diseases in the United States and other countries. The biopharmaceutical processes used for creating protein therapeutics, vaccine manufacturing, monoclonal antibody production, gene therapy, and other products are providing alternative forms of treatment to traditional pharmaceutical products. In recent years, some of these biopharmaceutical products have been used or have been in research and development to treat infectious diseases and potentially life-threatening illnesses, such as cancer. 

With some major distinctions throughout the development process, biopharmaceutical companies face different challenges that pertain specifically to the biopharmaceutical manufacturing process. Solutions to overcome these challenges differ for every step along the drug’s lifecycle, from discovery to clinical research to packaging.

Let’s review some critical considerations for the production of biopharmaceuticals and explore some solutions pertaining to the packaging portion of biopharmaceutical manufacturing.

Important Regulations for Biopharma 

The pharmaceutical industry and the biopharmaceutical industry in the United States are both subject to strict regulations in order to ensure quality and safety. The pharmaceutical industry and biopharmaceutical industry have the same U.S. Food and Drug Administration (FDA) regulations. However, the path to approval for each pharmaceutical product or biopharmaceutical product is different. 

Biopharmaceutical Product Approval 

The approval path for biotech in the United States involves submitting a Biologics License Application (BLA) to the Center for Biologics Evaluations and Research (CBER). The BLA for each biologics product must be approved by the CBER. This regulatory process for biopharmaceuticals is an important part of ensuring that products are safe before entering the market. 

Pharmaceutical Product Approval 

The approval path for traditional pharmaceutical products involves submitting a New Drug Application (NDA) through the FDA’s Center for Drug Evaluation and Research (CDER). The NDA includes test results for the product, manufacturing information, data from clinical trials, and a proposed label with information on the reason for use, how to use it, and potential risks. If the product’s benefits outweigh any known risks, the regulatory agency approves it for commercial manufacturing. 

DSCSA 

Applying to every drug, whether developed synthetically or naturally, the Drug Supply Chain Security Act (DCSCA) was created in the United States to improve traceability in the supply chain for pharmaceutical products. This act has several provisions that are aimed at making it easier to keep track of pharmaceutical products that enter the supply chain. This helps reduce the risk of having patients or consumers end up with counterfeit drugs or medicines. Although the law was enacted in 2013, full DSCSA implementation is set to occur in 2023, causing both pharmaceutical and biopharmaceutical companies to ask the question: Is our organization ready? 

Biopharmaceutical Manufacturing Process

Biopharmaceutical Processing 

The biopharmaceutical manufacturing process is more complex than other processes used to make synthetic or traditional pharmaceutical products. For biologics, process development involves having to obtain, grow, or reproduce living organisms, such as bacteria or cells, in order to create medicinal products. Working with living organisms rather than chemicals or other synthetic materials results in certain challenges in ensuring safety, quality, and efficacy.

Biopharmaceutical Packaging: Optimizing the Process

The packaging process is a significant part of these challenges since biologics need to remain in good condition until they are administered. These types of medicine are usually injected rather than taken in oral form or used in topical form. Unlike traditional pharmaceutical medicines, biopharmaceuticals are much more sensitive to temperature changes and environmental factors. Finding ways to optimize the biopharmaceutical packaging process can help biopharmaceutical companies reduce costs and keep their products in good condition. 

Key Challenges in Manufacturing Biologics 

Manufacturing biopharmaceuticals requires more complicated processes. The living organisms and biotechnology used for these products create challenges that make it difficult to produce, store, package, and transport them. This can lead to biologics that are deemed unsafe, ineffective, or unsuitable for use once they reach healthcare facilities or pharmacies. Knowing more about these challenges can help companies find solutions for handling them and optimizing the biopharmaceutical manufacturing and packaging processes overall. 

Cost

Manufacturing biopharmaceutical products typically has a high cost. When products cannot be used due to contamination, damage from heat, or other causes, this can cost biopharmaceutical companies a considerable amount of money. The companies then have to spend additional money on producing biologics again and run the risk of having the same or similar problems occur. 

Packaging solutions can provide an effective way for biopharmaceutical companies to keep lower costs since they help protect these products from damage, contamination, and other problems. 

Environmental Control

Pharmaceutical products made from chemicals have raw materials that aren’t as susceptible to temperature changes and other environmental factors. This makes it easier to store and transport  products without a high risk of having an active pharmaceutical ingredient become damaged or contaminated. 

With biopharmaceutical products, cells, bacteria, or other living organisms are much more vulnerable to damage or contamination due to environmental factors, such as changes in temperature or moisture exposure. These products tend to be highly sensitive to heat and can become easily contaminated. Ensuring environmental control throughout storage and transportation is essential, yet difficult to achieve. 

Regulations 

The pharmaceutical industry faces a number of regulations that help ensure drug safety. From purification processes to unit operations for drug manufacturing, these regulations are an important part of improving both product and patient safety. With so many pharmaceutical products being developed on a commercial scale and the increasing demand for biologics, companies must keep up with changes and new regulations. This can be a considerable challenge for biopharmaceutical manufacturing.

Innovative Packaging Solutions to Meet Biopharma’s Unique Needs

MPI has years of experience providing high-quality, dependable packaging solutions for pharmaceutical products. This extensive experience has allowed our company to develop effective solutions that help ensure medicinal products maintain their efficacy and are safe to use after being packaged and shipped to healthcare facilities or pharmacies.

This expertise extends to the biopharmaceutical industry with its unique needs and challenges. Our packaging solutions can help ensure that biopharma products avoid contamination and damage during storage and transportation. Our systems also contribute to overall operational efficiency and reduce medication errors. These solutions can help offset the high cost of producing biopharma products while ensuring that these products remain safe for use. 

MPI Products for Biopharma

At MPI, we offer packaging solutions aimed at meeting the challenges of storing and transporting biopharma products. Our oral liquid packaging products provide comprehensive solutions to virtually any liquid biopharmaceutical packaging requirement. Alongside our products, MPI’s Drug Master File (DMF) provides speed-to-market regulatory and technical support, helping our customers through the approval process in a shorter time period. 

The biopharma industry includes many products that are in the early stages of development. These products do not require large-volume manufacturing or packaging. Our cost-effective packaging solutions for specialty pharma manufacturers and repackagers ensure fast and efficient packaging that helps support the development and validation process. 

Liquid Medication Solutions 

FD-Pharma®

MPI offers an innovative solution for liquid medications. Our FD-Pharma Unit Dose Packaging System provides barcode packaging that ensures precise dosing for oral liquid medications. This cost-effective solution is suitable for clinical trials, validation runs, and low-volume production, as well as full production. FD-Pharma is a printing and pumping system for use with our MPI-certified packaging materials that meet FDA regulations. 

Fluidose® Series 6

The Fluidose Series 6 Unit Dose Packaging System from MPI is another barcoding packaging solution for liquid medications. This solution has a built-in syringe pump mechanism and can produce up to 22 doses per minute. Fluidose meets the Joint Commission’s regulations for dispensing liquid medications and includes our Pak-EDGE UD Barcode Labeling Software. 

Contact MPI for More Information on Our Biopharmaceutical Packaging Solutions!

If you are looking for more information on solutions for optimizing biopharmaceutical manufacturing and packaging, please contact MPI. Our team of experts is happy to help you find the best packaging solution for your unique organization and market. 

Medical Packaging Inc., LLC (MPI) is excited to announce the release of our new Pak-EDGE^® UD Barcode Labeling Software Version 2.0. 

The latest edition of our customizable labeling program, which provides user interface for MPI’s packaging solutions, offers simplified access to packaging features, enhanced security options, increased library capabilities and additional design elements to users for their medication labeling needs.

The design enhancements and added improvements to our barcode labeling software support our commitment to hospital pharmacy and pharmaceutical professionals with establishing medication management that increases efficiency and enhances patient safety.

Learn more about barcode labeling software by visiting the product page on our website. Please feel free to contact us to speak with a product expert for additional information, pricing and to order Pak-EDGE^® UD Barcode Labeling Software Version 2.0 for your facility.