There are many similarities between traditional pharmaceuticals and biopharmaceuticals. However, the key distinction is that biopharmaceuticals are products derived from biological sources and are manufactured in living organisms such as bacteria or human cells. Pharmaceuticals, on the other hand, are synthetic and are manufactured via chemical synthesis.

Biopharmaceutical products are employed across the healthcare industry to treat various diseases and other conditions. There is a myriad of different biopharmaceutical applications including vaccines, allergenics, hormones, blood factors and components, and gene and cell therapies. In some cases, biopharmaceuticals are able to more effectively treat a patient than traditional pharmaceuticals. For this reason, the biopharmaceutical industry continues to expand due to continuous innovation and demand, pushing the boundaries of science. With this growth, the manufacturing of biopharmaceutical products must also advance – highlighting the impact of silicone injection molding on the biopharmaceutical industry. Silicone injection molding processes are able to produce high volumes of products, such as syringes and implants, that make the delivery and administration of biopharmaceuticals easier, safer and more efficient. Simply put, the biopharmaceutical industry is directly linked to – and heavily relies on – silicone injection molding, and will continue to do so as both industries grow.

Why are Silicones a Good Fit for Biopharmaceuticals?

Silicone has long been a popular material for medical device manufacturers, and many of the benefits of using silicones in traditional pharmaceuticals are the same as in the biopharmaceutical industry.

Silicone is an excellent choice for biopharmaceutical products due to its durability, wide useful temperature range, chemical inertness, high tensile strength, vast range of available durometers, low toxicity, and compatibility with many sterilization methods. But the key characteristic that makes silicone the perfect match for biopharmaceuticals is its biocompatibility.

Biopharmaceutical devices and products often come in contact with the human body – either externally on a patient’s skin or internally as an implant that contacts tissue and fluids. Silicone is compatible with human tissue and body fluids, has a very low tissue response when implanted, and does not support bacteria growth. Simply put, medical grade silicones are unmatched in their biocompatibility, making silicones an excellent option for the biopharmaceutical industry. Additionally, medical grade silicones are often processed in special facilities called cleanrooms that reduce the potential for contamination. For example, all of ProMed’s manufacturing facilities are equipped with certified class 10,000 / ISO Class 7 cleanrooms, demonstrating a strong commitment to quality.

One application where medical-grade silicones really shine is drug-eluting implantable devices. Before molding, silicones can be compounded with biopharmaceuticals, such as hormones, which can then be steadily released into a targeted area of the patient’s body over time once the molded implant is inserted. Drug-eluting implants are able to maintain the desired dosage in the patient much more consistently and over a longer period of time than both pills and injections. Also, since the implant can usually be inserted near the targeted organ or tissue, lower doses are needed because the active biopharmaceutical ingredients do not need to spread throughout the entire body before reaching the targeted area. Silicone implantables are just one example of the impact silicone injection molding has on the biopharmaceutical industry.

Have a biopharmaceutical project that requires high quality and reproducibility?
Contact the ProMed team to discuss our silicone injection molding solutions.

Why is Silicone Injection Molding Best for the Biopharmaceutical Industry?

Silicone injection molding has several benefits compared to other molding processes, and below are some of its key advantages. Due to the high volumes required for many devices and products used in the biopharmaceutical sector, injection molding is often the most cost-effective manufacturing solution.

  • High Quality & Very Reproducible: silicone injection molding produces products that are virtually identical from part to part which provides excellent brand consistency and part reliability during high volume runs – this is especially crucial for parts and devices used in the biopharmaceutical industry. High reproducibility also allows for production to be scaled up to very large volumes, resulting in low costs per unit after the upfront equipment set-up costs are paid.
  • Excellent Versatility: silicone injection molding is a good choice for a wide range of part sizes, materials, and colors. Additionally, injection molding allows for the use of multiple materials simultaneously, allowing for a high degree of customization.
  • Able to Produce Complex Parts: silicone injection molding is typically performed at high pressure which forces the silicone into small crevices in the mold (that other molding processes are unable to reach), enabling the production of small, intricate and complex parts for the biopharmaceutical sector.
  • Efficient Production: silicone injection molding is a very fast process that generates high-output production compared to other molding methods, making injection molding a more efficient and cost-effective solution.
  • Low Waste Generation: silicone injection molding manufactures smooth products that have minimal finishing requirements after removal from the mold – resulting in less waste generation compared to other molding techniques.

ProMed Pharma’s Capabilities

ProMed Pharma is a leading contract manufacturer of polymer-based drug releasing molded dosage forms and combination device components, such as drug-eluting products. Working with both established and early-stage medical device and pharmaceutical companies, we develop robust manufacturing processes and platforms for extended drug release from a variety of materials, including silicones and thermoplastics.

We have garnered a reputation as the world benchmark of implantable silicone components and assemblies – and are one of few companies in the world to provide contract manufacturing of drug-eluting products.

ProMed has expertise in working with the full spectrum of silicones covering a wide range of properties and characteristics – including Liquid Silicone Rubber (LSR) that is an excellent option for drug-eluting medical products. We will assist in your material selection to help ensure all design requirements are met. Our manufacturing facilities and equipment are designed for a single purpose—to mold medical and implantable silicone, combination components, and bio-material grade plastics with uncompromising quality and service. We currently have four divisions that are located within two manufacturing sites. All are certified class 10,000 / ISO Class 7 cleanrooms.

Contact ProMed today at 763-331-3800 to discuss your next medical molding project.

Summary
Silicone Injection Molding’s Impact on the Biopharmaceutical Industry
Article Name
Silicone Injection Molding’s Impact on the Biopharmaceutical Industry
Description
Silicone injection molding’s impact on the biopharmaceutical industry including silicone’s biocompatibility, reproducibility, and ease of manufacturing.
Author
Publisher Name
ProMed Molding
Publisher Logo