<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 的前端创新总监 Tony Bradford 赞扬高剂量生物制剂作为关键药物递送形式的当前和未来潜力。图片来源：OMG_Studio via ShutterStock.com。</p>
<p>随着制药行业进一步进入个性化医疗时代，下一代靶向和疾病修饰生物制剂在所有主要疾病子类别中变得越来越普遍。</p>
<p>在向先进疗法转变的同时，公司现在正致力于开发以患者为中心的药物——将患者的舒适度和生活质量（QoL）置于开发过程的首位。</p>
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<p>这一趋势促使公司逐渐放弃静脉（IV）制剂，转而采用皮下（SC）版本的旗舰疗法，这可以减少患者的治疗管理时间。在某些情况下，药物也可以在家中服用——减少了患者的旅行负担和全球医疗系统的资源挑战。</p>
<p>根据药物递送专家 Phillips Medisize 的前端创新总监 Tony Bedford 的说法，行业将继续向 高剂量 SC 给药 的生物制剂转变，重点关注预填充注射器和自动注射器。</p>
<p><em>注意：本次采访已编辑以便于长度和清晰度。</em></p>
<h3>Annabel Kartal-Allen（AKA）：您能谈谈当前药物递送的趋势吗——特别是关于 SC 给药的使用？</h3>
<p><strong>Tony Bedford (TB)：</strong> 确实存在向 SC 给药的趋势，这种趋势已经持续了一段时间。在前十名畅销药物中，有八种是 SC 形式；这本身就说明了问题。向 SC 的转变通常是通过对 IV 疗法的重新配方实现的，尽管有些药物一开始就是作为 SC 配方开发的。</p>
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<h3>AKA：为什么行业中高剂量和大容量注射剂的普遍性有所增加？</h3>
<p><strong>TB：</strong> 主要驱动因素来自制药行业，但其优势也惠及患者和医疗专业人员（HCPs）。从生命周期管理的角度来看，制药公司通过创造新的高剂量配方的畅销药物，可以帮助延长 药物市场独占期。高剂量 SC 配方还可以将疗法引入不同的临床环境，这有助于提高疗法在其运营市场的接受度。</p>
<p>高剂量配方也使患者和 HCPs 受益，因为它们可以在门诊设施中安全地施用这些疗法，这比临床护理环境要快得多且便宜。这减少了医疗服务的 “床位阻塞”，同时减少了患者对长达四小时的医院就诊的依赖，这在 IV 给药中是必需的。</p>
<p>然而，在讨论 SC 生物制剂时，关于支付方和保险的某些问题仍未得到解答——主要源于这些药物的覆盖范围和方式。</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 的前端创新总监</p>
<h3>AKA：您能谈谈当前高剂量 SC 给药的最常见做法吗？</h3>
<p><strong>TB：</strong> 我们通常看到大容量 SC 模型，剂量在 9-23ml 之间，通过蝴蝶式注射器注入 SC 组织。</p>
<p>为了确保 SC 组织能够接受进入的药物，公司正在使用透明质酸酶进行配方，这是一种渗透增强剂。它还可以加速药物递送过程。</p>
<p>我们还看到预填充注射器和自动注射器的使用增加，这些设备通常容量在 5 毫升以下，因为通过这种方式成功输送更高容量的药物是有疑问的。这些配方通常包含透明质酸酶，因为它适合这种输送工具。机械设备——无论是电机驱动还是机械驱动——也被使用。这些设备可以是像贴片泵这样的体内设备，或者是一般形式的近体设备，通常是某种形式的导管。</p>
<p>这些类型的设备最适合慢性护理场景，这意味着患者需要在中长期内持续治疗。</p>
<h3>也就是说：皮下疗法的兴起会对医疗服务提供者产生任何意想不到的影响吗？</h3>
<p><strong>TB:</strong> 大容量皮下模型通常需要较长时间的努力来施用，这可能会让施治者感到不适——尤其是当药物粘度较高时。</p>
<p>虽然目前没有关于这种影响的数据，但我们确实听说医疗服务提供者在施用这些皮下药物时会感到不适或疼痛——尽管开发者通常更关注患者的舒适度，而不是医疗服务提供者的疼痛。</p>
<p>然而，公司正在探索通过配方方面的渗透增强剂（如透明质酸酶）来防止这种情况。或者，可以增加药物的体积以降低剂量的浓度——尽管这两者之间可能存在权衡。</p>
<p>我们还可以使用细壁针头并减慢输注速度，这样会稍微容易一些。</p>
<h3>也就是说：您认为目前有哪些输送方法正在推动从静脉输注转向皮下输送？</h3>
<p><strong>TB:</strong> 我想说是体内设备，但现在我认为是体内和近体设备的结合。当我们在 2016 年看到第一个体内注射器（OBI）推出时，我们都认为会有大量不同的配方通过 OBI 输送，但这并没有发生。</p>
<p>重要的是要注意，在从静脉输注转向皮下输送时，我们有很多工具可以帮助实现这一目标，已经有十几种 输送设备 获得了批准。技术已经存在，因此制药公司只需找到合适的设备来成功且安全地施用他们的药物。</p>
<h3>也就是说：您对高剂量皮下药物输送的未来有什么预测？</h3>
<p><strong>TB:</strong> 我认为手动推注射器在未来肯定会被使用。在这种格式下，我认为我们不会看到超过 23 毫升的药物，但我们可能会看到新药的剂量达到 15 毫升。我们还将看到大容量自动注射器的持续增加，分配 2-5 毫升。自动注射器和预填充注射器的使用将会增加，这将通过更高水平的透明质酸酶或等效的渗透增强剂来促进。</p>
<p>我们可能最终会看到体内贴片泵的使用，尽管对于高达 5 毫升的剂量，自动注射器可能会被优先选择。</p>
<p>我想在未来几年内，近体输送会有所增加，这可以是任何从 5 毫升以上的皮下配方。过去 18 个月，近体产品的增长已经非常巨大，所以我不明白为什么这种趋势不会继续。</p>
<p>我也希望看到进一步的进展，以 使更多的肿瘤药物实现皮下输送，这在某些其他疾病领域已经证明更具挑战性，因为它们的高毒性。通过引入与这种药物输送方法兼容的配方，将使患者和医生都更容易，因为治疗不需要在重症监护场景中进行。我们已经有近体和体内注射器，以及自动注射器和预填充注射器来实现这一目标，但必须在更大范围内实施这些类型的配方。</p>

<p>菲利普医疗的首席执行官托尼·贝德福德预测，随着制药行业向皮下（SC）药物递送转变，高剂量生物制剂将成为行业标准。这一趋势是由于对以患者为中心的疗法的需求，这些疗法能够提高舒适度并减少治疗时间。目前，前十名畅销药物中有八种已采用 SC 形式，显然正在逐步摆脱静脉（IV）制剂。高剂量的 SC 给药允许门诊治疗，减轻了医疗系统的压力，尽管在这些疗法的保险覆盖方面仍然存在挑战</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 的前端创新总监 Tony Bradford 赞扬高剂量生物制剂作为关键药物递送形式的当前和未来潜力。图片来源：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>随着制药行业进一步进入个性化医疗时代，下一代靶向和疾病修饰生物制剂在所有主要疾病子类别中变得越来越普遍。</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>在向先进疗法转变的同时，公司现在正致力于开发以患者为中心的药物——将患者的舒适度和生活质量（QoL）置于开发过程的首位。</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>这一趋势促使公司逐渐放弃静脉（IV）制剂，转而采用皮下（SC）版本的旗舰疗法，这可以减少患者的治疗管理时间。在某些情况下，药物也可以在家中服用——减少了患者的旅行负担和全球医疗系统的资源挑战。</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>根据药物递送专家 Phillips Medisize 的前端创新总监 Tony Bedford 的说法，行业将继续向 高剂量 SC 给药 的生物制剂转变，重点关注预填充注射器和自动注射器。</p>
</div><p><em>Note: This interview has been edited for length and clarity.</em></p>
<div class="lb-trans"><p><em>注意：本次采访已编辑以便于长度和清晰度。</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）：您能谈谈当前药物递送的趋势吗——特别是关于 SC 给药的使用？</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> 确实存在向 SC 给药的趋势，这种趋势已经持续了一段时间。在前十名畅销药物中，有八种是 SC 形式；这本身就说明了问题。向 SC 的转变通常是通过对 IV 疗法的重新配方实现的，尽管有些药物一开始就是作为 SC 配方开发的。</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：为什么行业中高剂量和大容量注射剂的普遍性有所增加？</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> 主要驱动因素来自制药行业，但其优势也惠及患者和医疗专业人员（HCPs）。从生命周期管理的角度来看，制药公司通过创造新的高剂量配方的畅销药物，可以帮助延长 药物市场独占期。高剂量 SC 配方还可以将疗法引入不同的临床环境，这有助于提高疗法在其运营市场的接受度。</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>高剂量配方也使患者和 HCPs 受益，因为它们可以在门诊设施中安全地施用这些疗法，这比临床护理环境要快得多且便宜。这减少了医疗服务的 “床位阻塞”，同时减少了患者对长达四小时的医院就诊的依赖，这在 IV 给药中是必需的。</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，在讨论 SC 生物制剂时，关于支付方和保险的某些问题仍未得到解答——主要源于这些药物的覆盖范围和方式。</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 的前端创新总监</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：您能谈谈当前高剂量 SC 给药的最常见做法吗？</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> 我们通常看到大容量 SC 模型，剂量在 9-23ml 之间，通过蝴蝶式注射器注入 SC 组织。</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>为了确保 SC 组织能够接受进入的药物，公司正在使用透明质酸酶进行配方，这是一种渗透增强剂。它还可以加速药物递送过程。</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>我们还看到预填充注射器和自动注射器的使用增加，这些设备通常容量在 5 毫升以下，因为通过这种方式成功输送更高容量的药物是有疑问的。这些配方通常包含透明质酸酶，因为它适合这种输送工具。机械设备——无论是电机驱动还是机械驱动——也被使用。这些设备可以是像贴片泵这样的体内设备，或者是一般形式的近体设备，通常是某种形式的导管。</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>这些类型的设备最适合慢性护理场景，这意味着患者需要在中长期内持续治疗。</p>
</div><h3>AKA: Will the rise of SC therapies have any unforeseen impacts on HCPs?</h3>
<div class="lb-trans"><h3>也就是说：皮下疗法的兴起会对医疗服务提供者产生任何意想不到的影响吗？</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较长时间的努力来施用，这可能会让施治者感到不适——尤其是当药物粘度较高时。</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>虽然目前没有关于这种影响的数据，但我们确实听说医疗服务提供者在施用这些皮下药物时会感到不适或疼痛——尽管开发者通常更关注患者的舒适度，而不是医疗服务提供者的疼痛。</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，公司正在探索通过配方方面的渗透增强剂（如透明质酸酶）来防止这种情况。或者，可以增加药物的体积以降低剂量的浓度——尽管这两者之间可能存在权衡。</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>我们还可以使用细壁针头并减慢输注速度，这样会稍微容易一些。</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>也就是说：您认为目前有哪些输送方法正在推动从静脉输注转向皮下输送？</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> 我想说是体内设备，但现在我认为是体内和近体设备的结合。当我们在 2016 年看到第一个体内注射器（OBI）推出时，我们都认为会有大量不同的配方通过 OBI 输送，但这并没有发生。</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，在从静脉输注转向皮下输送时，我们有很多工具可以帮助实现这一目标，已经有十几种 输送设备 获得了批准。技术已经存在，因此制药公司只需找到合适的设备来成功且安全地施用他们的药物。</p>
</div><h3>AKA: What are your predictions for the future of high-dose SC drug delivery?</h3>
<div class="lb-trans"><h3>也就是说：您对高剂量皮下药物输送的未来有什么预测？</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> 我认为手动推注射器在未来肯定会被使用。在这种格式下，我认为我们不会看到超过 23 毫升的药物，但我们可能会看到新药的剂量达到 15 毫升。我们还将看到大容量自动注射器的持续增加，分配 2-5 毫升。自动注射器和预填充注射器的使用将会增加，这将通过更高水平的透明质酸酶或等效的渗透增强剂来促进。</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>我们可能最终会看到体内贴片泵的使用，尽管对于高达 5 毫升的剂量，自动注射器可能会被优先选择。</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>我想在未来几年内，近体输送会有所增加，这可以是任何从 5 毫升以上的皮下配方。过去 18 个月，近体产品的增长已经非常巨大，所以我不明白为什么这种趋势不会继续。</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>我也希望看到进一步的进展，以 使更多的肿瘤药物实现皮下输送，这在某些其他疾病领域已经证明更具挑战性，因为它们的高毒性。通过引入与这种药物输送方法兼容的配方，将使患者和医生都更容易，因为治疗不需要在重症监护场景中进行。我们已经有近体和体内注射器，以及自动注射器和预填充注射器来实现这一目标，但必须在更大范围内实施这些类型的配方。</p>
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高剂量生物制剂的输送将成为行业标准