<p><img src="https://imageproxy.pbkrs.com/https://www.pharmaceutical-technology.com/wp-content/uploads/sites/24/2026/01/shutterstock_2578214995-430x241.jpg?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" original-src="https://imageproxy.pbkrs.com/https://www.pharmaceutical-technology.com/wp-content/uploads/sites/24/2026/01/shutterstock_2578214995-430x241.jpg"/></p>
<p>Phillips Medisize 的前端創新總監 Tony Bradford 讚揚高劑量生物製劑作為關鍵藥物遞送形式的當前和未來潛力。圖片來源：OMG_Studio via ShutterStock.com。</p>
<p>隨着製藥行業進一步進入個性化醫療時代，下一代靶向和疾病修飾生物製劑在所有主要疾病子類別中變得越來越普遍。</p>
<p>在向先進療法轉變的同時，公司現在正致力於開發以患者為中心的藥物——將患者的舒適度和生活質量（QoL）置於開發過程的首位。</p>
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<h4>生物仿製藥在製藥中的應用：基於激素的代謝疾病療法...</h4>
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<p>這一趨勢促使公司逐漸放棄靜脈（IV）製劑，轉而採用皮下（SC）版本的旗艦療法，這可以減少患者的治療管理時間。在某些情況下，藥物也可以在家中服用——減少了患者的旅行負擔和全球醫療系統的資源挑戰。</p>
<p>根據藥物遞送專家 Phillips Medisize 的前端創新總監 Tony Bedford 的説法，行業將繼續向 高劑量 SC 給藥 的生物製劑轉變，重點關注預填充注射器和自動注射器。</p>
<p><em>注意：本次採訪已編輯以便於長度和清晰度。</em></p>
<h3>Annabel Kartal-Allen（AKA）：您能談談當前藥物遞送的趨勢嗎——特別是關於 SC 給藥的使用？</h3>
<p><strong>Tony Bedford (TB)：</strong> 確實存在向 SC 給藥的趨勢，這種趨勢已經持續了一段時間。在前十名暢銷藥物中，有八種是 SC 形式；這本身就説明了問題。向 SC 的轉變通常是通過對 IV 療法的重新配方實現的，儘管有些藥物一開始就是作為 SC 配方開發的。</p>
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<h3>AKA：為什麼行業中高劑量和大容量注射劑的普遍性有所增加？</h3>
<p><strong>TB：</strong> 主要驅動因素來自制藥行業，但其優勢也惠及患者和醫療專業人員（HCPs）。從生命週期管理的角度來看，製藥公司通過創造新的高劑量配方的暢銷藥物，可以幫助延長 藥物市場獨佔期。高劑量 SC 配方還可以將療法引入不同的臨牀環境，這有助於提高療法在其運營市場的接受度。</p>
<p>高劑量配方也使患者和 HCPs 受益，因為它們可以在門診設施中安全地施用這些療法，這比臨牀護理環境要快得多且便宜。這減少了醫療服務的 “牀位阻塞”，同時減少了患者對長達四小時的醫院就診的依賴，這在 IV 給藥中是必需的。</p>
<p>然而，在討論 SC 生物製劑時，關於支付方和保險的某些問題仍未得到解答——主要源於這些藥物的覆蓋範圍和方式。</p>
<p><img src="https://imageproxy.pbkrs.com/https://www.pharmaceutical-technology.com/wp-content/uploads/sites/24/2026/01/Tony-Bedford-portrait-white-bg.jpg?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" original-src="https://imageproxy.pbkrs.com/https://www.pharmaceutical-technology.com/wp-content/uploads/sites/24/2026/01/Tony-Bedford-portrait-white-bg.jpg"/></p>
<p>Tony Bedford，Phillips Medisize 的前端創新總監</p>
<h3>AKA：您能談談當前高劑量 SC 給藥的最常見做法嗎？</h3>
<p><strong>TB：</strong> 我們通常看到大容量 SC 模型，劑量在 9-23ml 之間，通過蝴蝶式注射器注入 SC 組織。</p>
<p>為了確保 SC 組織能夠接受進入的藥物，公司正在使用透明質酸酶進行配方，這是一種滲透增強劑。它還可以加速藥物遞送過程。</p>
<p>我們還看到預填充注射器和自動注射器的使用增加，這些設備通常容量在 5 毫升以下，因為通過這種方式成功輸送更高容量的藥物是有疑問的。這些配方通常包含透明質酸酶，因為它適合這種輸送工具。機械設備——無論是電機驅動還是機械驅動——也被使用。這些設備可以是像貼片泵這樣的體內設備，或者是一般形式的近體設備，通常是某種形式的導管。</p>
<p>這些類型的設備最適合慢性護理場景，這意味着患者需要在中長期內持續治療。</p>
<h3>也就是説：皮下療法的興起會對醫療服務提供者產生任何意想不到的影響嗎？</h3>
<p><strong>TB:</strong> 大容量皮下模型通常需要較長時間的努力來施用，這可能會讓施治者感到不適——尤其是當藥物粘度較高時。</p>
<p>雖然目前沒有關於這種影響的數據，但我們確實聽説醫療服務提供者在施用這些皮下藥物時會感到不適或疼痛——儘管開發者通常更關注患者的舒適度，而不是醫療服務提供者的疼痛。</p>
<p>然而，公司正在探索通過配方方面的滲透增強劑（如透明質酸酶）來防止這種情況。或者，可以增加藥物的體積以降低劑量的濃度——儘管這兩者之間可能存在權衡。</p>
<p>我們還可以使用細壁針頭並減慢輸注速度，這樣會稍微容易一些。</p>
<h3>也就是説：您認為目前有哪些輸送方法正在推動從靜脈輸注轉向皮下輸送？</h3>
<p><strong>TB:</strong> 我想説是體內設備，但現在我認為是體內和近體設備的結合。當我們在 2016 年看到第一個體內注射器（OBI）推出時，我們都認為會有大量不同的配方通過 OBI 輸送，但這並沒有發生。</p>
<p>重要的是要注意，在從靜脈輸注轉向皮下輸送時，我們有很多工具可以幫助實現這一目標，已經有十幾種 輸送設備 獲得了批准。技術已經存在，因此製藥公司只需找到合適的設備來成功且安全地施用他們的藥物。</p>
<h3>也就是説：您對高劑量皮下藥物輸送的未來有什麼預測？</h3>
<p><strong>TB:</strong> 我認為手動推注射器在未來肯定會被使用。在這種格式下，我認為我們不會看到超過 23 毫升的藥物，但我們可能會看到新藥的劑量達到 15 毫升。我們還將看到大容量自動注射器的持續增加，分配 2-5 毫升。自動注射器和預填充注射器的使用將會增加，這將通過更高水平的透明質酸酶或等效的滲透增強劑來促進。</p>
<p>我們可能最終會看到體內貼片泵的使用，儘管對於高達 5 毫升的劑量，自動注射器可能會被優先選擇。</p>
<p>我想在未來幾年內，近體輸送會有所增加，這可以是任何從 5 毫升以上的皮下配方。過去 18 個月，近體產品的增長已經非常巨大，所以我不明白為什麼這種趨勢不會繼續。</p>
<p>我也希望看到進一步的進展，以 使更多的腫瘤藥物實現皮下輸送，這在某些其他疾病領域已經證明更具挑戰性，因為它們的高毒性。通過引入與這種藥物輸送方法兼容的配方，將使患者和醫生都更容易，因為治療不需要在重症監護場景中進行。我們已經有近體和體內注射器，以及自動注射器和預填充注射器來實現這一目標，但必須在更大範圍內實施這些類型的配方。</p>

<p>菲利普醫療的首席執行官託尼·貝德福德預測，隨着製藥行業向皮下（SC）藥物遞送轉變，高劑量生物製劑將成為行業標準。這一趨勢是由於對以患者為中心的療法的需求，這些療法能夠提高舒適度並減少治療時間。目前，前十名暢銷藥物中有八種已採用 SC 形式，顯然正在逐步擺脱靜脈（IV）製劑。高劑量的 SC 給藥允許門診治療，減輕了醫療系統的壓力，儘管在這些療法的保險覆蓋方面仍然存在挑戰</p>

<p><img src="https://imageproxy.pbkrs.com/https://www.pharmaceutical-technology.com/wp-content/uploads/sites/24/2026/01/shutterstock_2578214995-430x241.jpg" alt="" original-src="https://www.pharmaceutical-technology.com/wp-content/uploads/sites/24/2026/01/shutterstock_2578214995-430x241.jpg"/></p>
<p>Phillips Medisize’s director of Front-End Innovation, Tony Bradford, touts the current and future potential of high-dose biologics as a key drug delivery format. Image credit: OMG_Studio via ShutterStock.com.</p>
<div class="lb-trans"><p>Phillips Medisize 的前端創新總監 Tony Bradford 讚揚高劑量生物製劑作為關鍵藥物遞送形式的當前和未來潛力。圖片來源：OMG_Studio via ShutterStock.com。</p>
</div><p>As the pharmaceutical industry progresses further into the age of personalised medicine, next-generation, targeted and disease-modifying biologics are becoming increasingly commonplace across all major disease subcategories.</p>
<div class="lb-trans"><p>隨着製藥行業進一步進入個性化醫療時代，下一代靶向和疾病修飾生物製劑在所有主要疾病子類別中變得越來越普遍。</p>
</div><p>Alongside the shift to advanced therapies, companies are now looking to develop drugs with patient centricity in mind – putting a patient’s comfort and quality of life (QoL) at the forethought of the development process.</p>
<div class="lb-trans"><p>在向先進療法轉變的同時，公司現在正致力於開發以患者為中心的藥物——將患者的舒適度和生活質量（QoL）置於開發過程的首位。</p>
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</div><p>This trend has prompted companies to move away from intravenous (IV) formulations in favour of subcutaneous (SC) versions of flagship therapies, which can reduce the time of treatment administration for patients. In some cases, medication can also be taken at home – reducing both travel burden on patients and resource challenges on overstretched global healthcare systems.</p>
<div class="lb-trans"><p>這一趨勢促使公司逐漸放棄靜脈（IV）製劑，轉而採用皮下（SC）版本的旗艦療法，這可以減少患者的治療管理時間。在某些情況下，藥物也可以在家中服用——減少了患者的旅行負擔和全球醫療系統的資源挑戰。</p>
</div><p>According to Tony Bedford, director of Front-End Innovation at drug delivery specialist Phillips Medisize, the industry will continue to see a move towards high-dose SC administration of biologics, with a prime focus on prefilled syringes and autoinjectors.</p>
<div class="lb-trans"><p>根據藥物遞送專家 Phillips Medisize 的前端創新總監 Tony Bedford 的説法，行業將繼續向 高劑量 SC 給藥 的生物製劑轉變，重點關注預填充注射器和自動注射器。</p>
</div><p><em>Note: This interview has been edited for length and clarity.</em></p>
<div class="lb-trans"><p><em>注意：本次採訪已編輯以便於長度和清晰度。</em></p>
</div><h3>Annabel Kartal-Allen (AKA): Could you talk me through the current trends in drug delivery – specifically around the use of SC delivery?</h3>
<div class="lb-trans"><h3>Annabel Kartal-Allen（AKA）：您能談談當前藥物遞送的趨勢嗎——特別是關於 SC 給藥的使用？</h3>
</div><p><strong>Tony Bedford (TB):</strong> There is definitely a trend towards SC administration, which has been ongoing for some time. Of the top 10 selling drugs, eight are in a SC format; that in itself tells a story. The move towards SC is often seen through the reformulation of an IV therapy, though some drugs are developed as a SC formulation to start with.</p>
<div class="lb-trans"><p><strong>Tony Bedford (TB)：</strong> 確實存在向 SC 給藥的趨勢，這種趨勢已經持續了一段時間。在前十名暢銷藥物中，有八種是 SC 形式；這本身就説明了問題。向 SC 的轉變通常是通過對 IV 療法的重新配方實現的，儘管有些藥物一開始就是作為 SC 配方開發的。</p>
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</div><h3>AKA: Why has the industry seen an increase in the prevalence of high-dose and large-volume injectables?</h3>
<div class="lb-trans"><h3>AKA：為什麼行業中高劑量和大容量注射劑的普遍性有所增加？</h3>
</div><p><strong>TB:</strong> The main driver is coming from pharma, but the advantage spreads to patients and healthcare professionals (HCPs) as well. It benefits pharma from a life cycle management perspective, as creating new, high-dose formulations of best-selling drugs can help extend the life of a drug’s market exclusivity. High-dose SC formulations can also introduce therapies into different clinical settings, which can help to boost a therapy’s uptake across the market it operates in.</p>
<div class="lb-trans"><p><strong>TB：</strong> 主要驅動因素來自制藥行業，但其優勢也惠及患者和醫療專業人員（HCPs）。從生命週期管理的角度來看，製藥公司通過創造新的高劑量配方的暢銷藥物，可以幫助延長 藥物市場獨佔期。高劑量 SC 配方還可以將療法引入不同的臨牀環境，這有助於提高療法在其運營市場的接受度。</p>
</div><p>High-dose formulations also benefit patients and HCPs, as they can allow these therapies to be safely administered in an outpatient facility, which is much faster and cheaper than the clinical care setting. This reduces ‘bed blocking’ for healthcare services, while reducing the patient’s reliance on up to four-hour-long hospital visits required for IV delivery.</p>
<div class="lb-trans"><p>高劑量配方也使患者和 HCPs 受益，因為它們可以在門診設施中安全地施用這些療法，這比臨牀護理環境要快得多且便宜。這減少了醫療服務的 “牀位阻塞”，同時減少了患者對長達四小時的醫院就診的依賴，這在 IV 給藥中是必需的。</p>
</div><p>However, there are some unanswered questions around how payers and insurance when discussing SC biologics – primarily stemming from where and how these drugs get covered.</p>
<div class="lb-trans"><p>然而，在討論 SC 生物製劑時，關於支付方和保險的某些問題仍未得到解答——主要源於這些藥物的覆蓋範圍和方式。</p>
</div><p><img src="https://imageproxy.pbkrs.com/https://www.pharmaceutical-technology.com/wp-content/uploads/sites/24/2026/01/Tony-Bedford-portrait-white-bg.jpg" alt="" original-src="https://www.pharmaceutical-technology.com/wp-content/uploads/sites/24/2026/01/Tony-Bedford-portrait-white-bg.jpg"/></p>
<p>Tony Bedford, director of Front-End Innovation at Phillips Medisize</p>
<div class="lb-trans"><p>Tony Bedford，Phillips Medisize 的前端創新總監</p>
</div><h3>AKA: Can you talk me through the current most common practices for high-dose SC administration?</h3>
<div class="lb-trans"><h3>AKA：您能談談當前高劑量 SC 給藥的最常見做法嗎？</h3>
</div><p><strong>TB:</strong> We commonly see large volume SC models, with doses between 9-23ml given through a butterfly-type syringe into the SC tissue.</p>
<div class="lb-trans"><p><strong>TB：</strong> 我們通常看到大容量 SC 模型，劑量在 9-23ml 之間，通過蝴蝶式注射器注入 SC 組織。</p>
</div><p>To ensure that the SC tissue accepts the drug coming in, companies are formulating with hyaluronidase, which is a permeation enhancer. It can also speed up the drug delivery process.</p>
<div class="lb-trans"><p>為了確保 SC 組織能夠接受進入的藥物，公司正在使用透明質酸酶進行配方，這是一種滲透增強劑。它還可以加速藥物遞送過程。</p>
</div><p>We’re also seeing increased use of prefilled syringes and autoinjectors, which tend to be under 5ml, as it’s questionable if a higher volume will be successfully delivered through this method. These formulations often include hyaluronidase, as it’s suitable for that kind of delivery vehicle. Mechanised devices – either electromechanical or mechanical – are also used. These can be either an on-body device like a patch pump, or a near-body device, which is generally some form of cannula.</p>
<div class="lb-trans"><p>我們還看到預填充注射器和自動注射器的使用增加，這些設備通常容量在 5 毫升以下，因為通過這種方式成功輸送更高容量的藥物是有疑問的。這些配方通常包含透明質酸酶，因為它適合這種輸送工具。機械設備——無論是電機驅動還是機械驅動——也被使用。這些設備可以是像貼片泵這樣的體內設備，或者是一般形式的近體設備，通常是某種形式的導管。</p>
</div><p>Most of these types are best suited to chronic care scenarios, meaning patients are needing consistent treatment over a mid- or long-term basis.</p>
<div class="lb-trans"><p>這些類型的設備最適合慢性護理場景，這意味着患者需要在中長期內持續治療。</p>
</div><h3>AKA: Will the rise of SC therapies have any unforeseen impacts on HCPs?</h3>
<div class="lb-trans"><h3>也就是説：皮下療法的興起會對醫療服務提供者產生任何意想不到的影響嗎？</h3>
</div><p><strong>TB:</strong> Large volume SC models generally take a prolonged period of effort to administer, which may be uncomfortable for the person giving the treatment – especially if the drug is of a high viscosity.</p>
<div class="lb-trans"><p><strong>TB:</strong> 大容量皮下模型通常需要較長時間的努力來施用，這可能會讓施治者感到不適——尤其是當藥物粘度較高時。</p>
</div><p>While there isn’t currently any data on this impact, we do hear that HCPs are dealing with discomfort or pain when administering these SC drugs – though it’s generally more common for developers to consider comfort for the patient rather than pain on the HCP side.</p>
<div class="lb-trans"><p>雖然目前沒有關於這種影響的數據，但我們確實聽説醫療服務提供者在施用這些皮下藥物時會感到不適或疼痛——儘管開發者通常更關注患者的舒適度，而不是醫療服務提供者的疼痛。</p>
</div><p>However, companies are exploring ways to prevent this on the formulation side with permeation enhancers like hyaluronidase. Alternatively, the volume of the drug can be increased to reduce the dose’s concentration – though there can be a trade-off between the two.</p>
<div class="lb-trans"><p>然而，公司正在探索通過配方方面的滲透增強劑（如透明質酸酶）來防止這種情況。或者，可以增加藥物的體積以降低劑量的濃度——儘管這兩者之間可能存在權衡。</p>
</div><p>We can also employ thin-wall needles and slow the rate of infusion, which makes it a little easier.</p>
<div class="lb-trans"><p>我們還可以使用細壁針頭並減慢輸注速度，這樣會稍微容易一些。</p>
</div><h3>AKA: Are there any delivery approaches you believe are currently championing the shift from IV to SC?</h3>
<div class="lb-trans"><h3>也就是説：您認為目前有哪些輸送方法正在推動從靜脈輸注轉向皮下輸送？</h3>
</div><p><strong>TB:</strong> I’d like to say it’s on-body, but right now I think it’s a combination of on-body and near-body. When we saw the first on-body injector (OBI) launch in 2016, we all thought the floodgates would open and there would be a bunch of different formulations delivered through OBI, and that hasn’t happened.</p>
<div class="lb-trans"><p><strong>TB:</strong> 我想説是體內設備，但現在我認為是體內和近體設備的結合。當我們在 2016 年看到第一個體內注射器（OBI）推出時，我們都認為會有大量不同的配方通過 OBI 輸送，但這並沒有發生。</p>
</div><p>It’s important to note that, when making the switch from IV to SC, there are plenty of tools at our disposal that can help achieve this goal, with a dozen or so d elivery devices already gaining approval. The technology is out there, so now pharma companies just have to find the right device to successfully and safely administer their drug.</p>
<div class="lb-trans"><p>重要的是要注意，在從靜脈輸注轉向皮下輸送時，我們有很多工具可以幫助實現這一目標，已經有十幾種 輸送設備 獲得了批准。技術已經存在，因此製藥公司只需找到合適的設備來成功且安全地施用他們的藥物。</p>
</div><h3>AKA: What are your predictions for the future of high-dose SC drug delivery?</h3>
<div class="lb-trans"><h3>也就是説：您對高劑量皮下藥物輸送的未來有什麼預測？</h3>
</div><p><strong>TB:</strong> I think manual push syringes will definitely be used moving forward. In this format, I don’t think we will see anything much larger than 23ml, but we will likely see new drugs come in at up to 15ml. We’ll also see a continued increase in larger volume autoinjectors dispensing 2-5ml. Both autoinjectors and prefilled syringes will see a rise, which will be facilitated by higher levels of hyaluronidase or an equivalent permeation enhancer.</p>
<div class="lb-trans"><p><strong>TB:</strong> 我認為手動推注射器在未來肯定會被使用。在這種格式下，我認為我們不會看到超過 23 毫升的藥物，但我們可能會看到新藥的劑量達到 15 毫升。我們還將看到大容量自動注射器的持續增加，分配 2-5 毫升。自動注射器和預填充注射器的使用將會增加，這將通過更高水平的透明質酸酶或等效的滲透增強劑來促進。</p>
</div><p>We may also finally see uptake of on-body patch pumps, though autoinjectors may be chosen over these solutions for doses up to 5ml.</p>
<div class="lb-trans"><p>我們可能最終會看到體內貼片泵的使用，儘管對於高達 5 毫升的劑量，自動注射器可能會被優先選擇。</p>
</div><p>I imagine there will be an increase in near-body delivery over the next few years, which can be anything from 5ml upwards for SC formulations. The growth of near-body products over the last 18 months has been enormous already, so I don’t see why that wouldn’t continue.</p>
<div class="lb-trans"><p>我想在未來幾年內，近體輸送會有所增加，這可以是任何從 5 毫升以上的皮下配方。過去 18 個月，近體產品的增長已經非常巨大，所以我不明白為什麼這種趨勢不會繼續。</p>
</div><p>I’d also hope to see further strides to make more oncology drugs SC, which has proven more challenging than in some other disease areas due to their high toxicity. By introducing formulations compatible with this type of drug delivery method, it would make it easier for both the patient and physician, as treatment doesn’t need to be conducted in the critical care scenario. We’ve got near and on-body injectors, as well as autoinjectors and prefilled syringes to achieve this goal, but more work must be done to implement these types of formulations on a broader scale.</p>
<div class="lb-trans"><p>我也希望看到進一步的進展，以 使更多的腫瘤藥物實現皮下輸送，這在某些其他疾病領域已經證明更具挑戰性，因為它們的高毒性。通過引入與這種藥物輸送方法兼容的配方，將使患者和醫生都更容易，因為治療不需要在重症監護場景中進行。我們已經有近體和體內注射器，以及自動注射器和預填充注射器來實現這一目標，但必須在更大範圍內實施這些類型的配方。</p>
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高劑量生物製劑的輸送將成為行業標準